CREW: Food and Drug Administration - Plan B: OL4

Oct-07-05 ' 08 :57am From-5laushte r 202-225-7822 T-642 P .
002/D07 F-32 6
October 7, 2005
Andrew von Eschenbach, M .D.

Acting Commissioner
.Food and Drug Administration
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 2085 2
RE : Docket No . 2005N-034 5
Dear Acting Commissioner von Eschenbach:
As Members of the Bipar tisan Congressional Pro-Choice Caucus, we are submitting the
following remarks in response to your request for public comment on over-the-counter sales_ of
Plan B .
First and foremost, we are very disappointed with then-Conumu5sioner Crawford'srYatiaotmcement a a

on August 26, 2005, to further delay the FDA's decision on over-the-counter
. :r . sales of Plan B
~
emergency contraception (EC) . We believe this new delay does not truly reflect va4d scientific
or regulatory concerns .
In late 2003, the FDA's own expert Advisory Panel voted overwhelmingly in favor (23-4) of
allowing over-the-counter sales .of Barr Laboratones'
: Plan
~. B_ The
.~Advisory
. Panel d FDA's
professional and scientific staff concluded. . that EC.~.:mccts standard
.~,~;:.•~. . criteria
. _ . ..~ for over.. untez
.,..~,~ . ~. , . .
:.. .~..
use : low-toxicity; no potential for overdose or addaehon ; no teratog enicrty ('u not fiazmful to an
existing pregnancy) ; no need for medical screening.- self-identification of the need; t I i niform
dosage ; and no significant drug interactions . Yet, 20 montbs later, the FDA still rcj$ ses to
accept a sensible, safe solution to preventing unintended pregnancies .
Other studies have also proven the effectiveness and safety of Plan B . A recent policy statement
by the American Academy of Pediatrics highlights the fact that Plan : Bhas no contriindtca .~ s
. Y. ., .. __. _ ..tion ....,.:.
and points to a study featured in the Journal.of Obstetrics & Gynecology, t which concludes that
young women are able to use EC "effectively and safely without health care provid~r
intervention : " Experts estimate that wider access to EC would prevent 1 .7 million,#niatended
pregnancies and 800,000 abortions each year. By further delaying the FDA's decisioa to .expand
access to EC, you are seriously hindering efforts to reduce abortions across the U.S .;
. ..
Raymond EG, Chen, PL, Da(ebout SM . "Actual use" study'of emergency contraceptive p Is provided i n
4
a simulated over-the-counter manner. Obstet GynecoL 2003 ; 102:17-23 .
__ ... .__ . .__. . ._. ,.~ .: . .. _,_ . .- ._ ~-- - ~
PRINTED ON P9C7p.E0 PhAER;

Oct-07-05 08 :57am From-Slaughter Z02-Z25-7822 T-642 P .003/007 F-32 6
Last May, the FDA rejected Barr Laboratories' first application for providing EC over-the-
counter. The FDA cited the concern tat ~ ._ .easier
m,. ~access to EC~ might lead to promiscuity amon g
. ..:.~~
women under the age of 16, despite numerous studies disproving this claim . The FDA stated
that unless an age-based sales distinction was made, it would aot approve Baku Labaitatories'
application . In order to address the FDA's concern, Barr Laboratories_ . submitted
, a :qew
..
application to the FDA to provide over-the-counter sales of ECto : women . 16 years and older.
On August 26, 2005, more than one year later, the FDA released a statement expressing its
sentiment that selling EC to two different age groups would present regulatory conc6rns . We
find it contradictory and disconcerting that the FDA's concerns are a direct result ofthe agency's
own recommendatrions last May .
We are displeased that the FDA continues to delay, postpone and create impedimenis to is suing a
decision on an application that its own expert advisory committee endorsed nearly 20 months
ago . U,iifortuuately, this important decision has been delayed too long and at the expense of
women's reproductive health_ throughout the country. We, therefore, strongly urge t~.e FDA to
approve Barr Laboratories' application without further delay . Thank you for your fmmediate
consideration .
Sincerely,
-T---
Oct-07-05 OB :56am From-Slauihter 202-ZZ5-7822 ' T-642 i P :004/007 F-326
Oct-07-05 08 :58am From-Slauirhter Z02-1Z5- 7 822 T-64 P .005/007 F-32 8
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Oct-O7-05 08 :58am From-Slauihter 202-225-7822 T-642 i P .006/00T F-326
li
Oct-D7-05 08 :58am From-Slaughte r 202-225-7B22 T-642 P : 0 77 017 F-32 6
1 . Louise M . Slaughter, Member of Congress 32. Luis V . Gutierrez, , Member, of Congress

2 . Judy Biggert, Member of Congres s 33 . Jane Hannan, Member of C?ngres s
3 . Diana L . DeGette, Member of Congres s 34. Maurice Hinchey, Member of Congress
4. Robert R. Simmons . Member of Congress 35 . Jesse Jackson, Jr. , Member of Congress
5 . Rosa DeLauro,lVieznber of Congres s 36 . Rick Larsen, Member of Congres s
6. Sherwood L . Boehlert, Member of Congress 37 . Barbara Lee, Member of Congress
7 . Tom Lantos, Member of Congres s 38 . Sheila Jackson Lee, Mexnbe~ of . Congress
8 . Nancy L . Johnson, Member of Congress 39 . Sander Levin, Member of Congress
9 . Nita M. Lowey, Member of Congress 40 . John Lewis, Member of Corigress
10 . Mark S . Rirk, Member of Congress 41 . Zoe Lofgren, Member of Cangres s
11 . Henry A. Waxman, Member of Congress 42 . Carolyn Maloney, Member of Congress
12_ Christopher Shays, Member of Congress 43 . Betty McCollum, Member of Congress
. . ., . . .
13 . Neil Abercrombie, Member of Congress 44_ Tim McDeirmott; Member oConsres s
14. Thomas H . Allen, Member of Congress 45 . James P : McGovern, Member of Congress
15 . Joe Baca, Member of Congres s 46 . Gwen Moore, Member of Congress
16. Tammy Baldwin, Member of Congress 47 . Jerrold Nadler, Member of Congress
17- Earl Blumenauer, Member of Congress 48 . John W. OIver; Member of Congres s
18 . Sherrod Brown, Member of Congress 49 . Steven R. Rothman, Member of Congress
19. Lois Capps, Member of Congres s 50 . Lucille Roybal-All ard, Mer~ber of Congress
20. Michael E . Capuano, Member of Congress 51 . Martin 01av Sabo, Member of Congres s
21 . Russ Carnahan, Member of Congres s 52 . Linda T. Sanchez, Member of Congress
22. Julia Carson, Member of Congress 53 . Bernard Sanders, Member of Congress
23 : Joseph Crowley, Member of Congress 54. Jan Schakowsky, Member Of Congress
24 . Elijah Cummings, Member of Congress 55 . Adam Schiff, Member of Congres s
25 . Susan Davis, Member of Congress 56 . Debbie Wasserman Schultz„ Member of
26. Peter DeFazio, Member of Congress Congress
27 . William Delabunt, Member of Congress 57 . Adam Snsith, Member of Congress
28 . Lloyd Doggett, Member of Congres s 58 . Hilda L. Solis, Member of Congress
29 . Anna Eshoo,lV.[ember of Congress 59 . Pete Statk, Member of Conoes s
30 . Sam Farr, Member of Congres s 60. Chris Van Holleq Member of Congress
31_ Raul M. Grijalva, Member of Congress 61 . Diane E .Watson, Member Qf Congress
62 . Lynn Woolsey, Member of Congress
Oct-07-05 0847am From-Slaughte r 202-225-7822 T-842 rP :001/007 F-32 6
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FROM THE WASHIIKGTOIN OFFICE OF

CONGRESSWOMAN LOUISE M. SLAUGS'T'ER
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CommmstTs: PD R i.~oc.4k No . 20015 N -r 0 3 q5
If you did not receive all pages, please call (202) 225-361 5
Washington office fax number, (202)'22S-7822

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICE S
Food and Drug Administration

Rockville MD 2085 7
The Honorable Judy Biggert

Rouse of Representatives
Washington, D . C . 20515 1313 NOV 1 2005
Dear Ms . Biggert :
Thank you for the letter of October 7, 2005, co-signed by 61 other members of the Pro-Choice
Caucus in the House of Representatives concerning the Food and Drug Administration's
(FDA or the Agency) review of the application by Barr Laboratories to market their product,
Plan B, over-the-counter (OTC) instead of by prescription .
On September 1, 2005, FDA created a new public docket for the purpose of receiving
comments regarding the advance notice of proposed rulemaking (ANPR) announced by FDA
concerning the proposal to change Plan B to OTC status . This Docket No .'2005N-0345 will
be open to receive comments until November .1, 2005 . We have forwarded your letter to be
included as a formal part of the docket record on this issue . Since over a thousand comments
already have been received, the Center for Drug Evaluation and Research (CDER) soon will
begin reviewing and compiling the suggestions and comments received on the several issues
addressed in the rulemaking .
At the top of page two of your letter, however, you a ttribute to FDA a concern that the
Agency has never expressed about the proposed Plan B switch to OTC status and we would
like to correct the record on this matt er at this time . Your letter says "The FDA cited the
concern that easier access to EC might lead to promiscuity among women under the age of
16 . . . ." Although similar statements may have appeared in other writings outside of the
Agency concerning this issue, FDA has never made such a statement . So there will be no
confusion about the public statements FDA actually has made conce rning the Plan B
application, we are enclosing copies of the two press releases dated May 7, 2004, an d
August 26, 2005, that the Agency has issued concerning this application . In addition, we are
enclosing a copy of the May 6, 2004, letter fr om Steve Galson,M .D . ,' Director of CDER, to
Barr Laboratori es an d the letter identi fi ed as NDA 21-045/S-01 l from former
.. Commissioner
_
of Food and Drugs, Lester M . Crawford, D .Vavi :, Ph:D ; to Duramed Research, Inc .,
concerning the ANPR .
Page 2 - The Honorable Judy Biggert
Thank you again for your continued interest in this matter . An identical letter has been sent
to your co-signers . If we can be of further assistance, please let us know .
Sincerely ,
Patrick Rona n
Associate Commissioner
for Legislation 1
4 Enclosures
cc : Docket Management Branch - HFA-305

(Docket No . 2005N-0345)
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servic e

Rockville MD 2085 7
The Honorable Joseph Crowley

House of Representatives
Washington, D .C . 20510-320 7 MAR 2 ZUU U
Dear Mr. Crowley :
Thank you for the letter of September 22, 2005, co-signed by Representative Carolyn B . Maloney
in which you exp re ss your conce rn s about the Food and Drug Administration's (FDA or the
Agency) processing of the supplemental new drug application from Barr Laboratori es (now owned
by Duramed Research, Inc .) that proposes to change the marketing status of the d ru g, Plan B, from
prescri ption only to over-the-counter (OTC) .
Your letter cites the 23-4 vote taken at the joint advisory commi tt ee meeting in December 2003,
recommending that Plan B be sold OTC . Advisory commi ttee opinions are only advisory in
nature and are not binding on the Agency . The final determination on any new drug application
(NDA) always is the responsibility of FDA . It is up to the Agency to clari fy any unanswered
questions that may remain after the close of an adviso ry commi tt ee meeting or that were identified
du ri ng the meeting, even though a vote may have been taken on the main question(s) before the
committee . The busy schedules of the committee members-.require that advisory committee
meetings be scheduled well in advance . We certainly value the input from adviso ry committee
members and the opportunity to hear an exchange of ideas on proposed new products from expe rts
in their respective scientific fields . It should not be presumed, however, that a favorable vote by
an advisory committee automatically means that a product is ready to go to the pharmacy shelves .
FDA is charged by Congress with reviewing new drug applications to determine a proposed new
product's safety and effectiveness for the uses put forth by the manufacturer in the application .
As a science-based agency, it is FDA that must make that final determination on whether an
application for a product adequately demonstrates that the data presented supports the proposed
uses stated by the manufacturer in the proposed labeling . A product cannot be approved until
FDA determines that the product is safe and effective for the indications stated in the proposed
labeling .
We would like to take this opportunity to clarify below the current status of the Agency's
activities concerning the application of the sponsor, to change the marketing status of Plan B from
prescription only to OTC . In May of 2004, FDA completed its first review of the new drug
application to switch Plan B to OTC, and concluded that the application could not be approved at
that time because : 1) adequate data were not provided to support a conclusion that young
adolescent women can safely and effectively use Plan B for emergency contraception
i
Page 2 - The Honorable Joseph Crowle y
without the professional supervision of a licensed practitioner, and 2) an amended proposal

submitted by the sponsor during the review cycle to change the requested indication to allow for
marketing of Plan B as a prescription only product for women under 16 years of age and a
nonprescription product for women 16 years and older was incomplete and inadequate for a full
review. This message was conveyed to the sponsor by the Acting Director of FDA's. Center.for.
Drug Evaluation and Research (CDER) with a full explanation of the reasons behind FDA's .
decision in a Not Approvable letter dated May 6, 2004 (copy enclosed) and available online at :
(www.fda .gov/cder/drug/anfopage/planB_NALetter .pdf ) .
That decision by the Acting Director of CDER was made after full review of-all the underlying
data and analysis and after discussions ,with all_of the appropriate Agency personnel . This
decision was based on his assessment that the data in the supplemental application did not contain
sufficient information about whether younger adolescent women could understand the label and
use the product safely and effectively for emergency contraception without the professional
supervision of a licensed practitioner . Therefore, the data in the application did not support
approval of the supplement . In its Not Approvable letter to the sponsor, FDA outlined some
additional information that would be required for approval to market Plan B as an OTC drug . The
issuance of a Not Approvable letter did not mean that a supplemental application could not or
would not be approved in the future .
In July 2004, the drug's sponsor amended its supplemental application seeking to mak e
Plan B an OTC product for women age 16 and over, and to have it remain prescription only for
women under age 16. The company also sought to market Plan B in a single package, and sold
either as prescription only or OTC, depending on the age of the purchaser .
In August 2005, FDA wrote a letter to the Duramed. Research, Inc ., (copy enclosed and available
at : http ://www .fda .gov/cder/drug/infopage/planB/Plan_B_Ietter20050826.pdj) stating that FDA
had completed its review of the application and that the scientific data suppo rt ed the safe and
effective use of Plan B as an OTC product for women ages 17 and over. FDA also stated,
however, that it was unable at that time to reach a final decision on the approvability of the
application due to unresolved issues that related to the application .
In the lett er to the sponsor, FDA identifi ed three diffi cult and _novel issues presented by the
application, issues for which the Agency is committed to a process for resolving . That process
was initiated with the publication on September 1, 2005, of an Advance Notice of Proposed
Rulemaking (ANPRM) in the Federal Register seeking comment on questions related to section
503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act ( Title 21, United States Code
353(b)) . The questions the interested pa rt ies were asked to respond to concern when an active
ingredient of a drug may be simultaneously marketed as both a presc ri ption an d as an OTC drug
product, whether and how OTC availability of a product could be rest ri cted to a pa rticular
subpopulation, and whether the same packaged product could be sold either as presc ri ption only or
OTC, depending on the age of the purchaser . A related conce rn is how, as a practical matter, an
age-based distinction could be enforced.
r
Page 3 - The Honorable Joseph Crowle y
As the Agency has said many times during the course of the review, of this application, the
questions that FDA was asked to answer, and the proposal that was put forward by the sponsor,
presented the Agency with many very difficult and novel policy and regulatory questions . In
some cases, the questions requiring an FDA response were unprecedented for this Agency .
An ANPRM is a mechanism to ask for public comments on whether the Agency should initiate a
rulemaking to codify our interpretation of section 503(b) of the FD&C Act regarding when an
active ingredient can simultaneously be marketed in both a prescription drug product and an OTC
drug product for the same indication, strength, dosage form and route of administration .
Although the Agency typically solicits public comment for a minimum of 90 days when initiating
this type of process, in the interest of moving quickly on this issue, the comment period was
shortened to 60 days for this ANPRM . The public comment period on these questions closed as
of November 1, 2005, and FDA is reviewing the comments and letters it received . While we,
cannot put an exact timeline on how long it will take to process these comments, we are
committed to moving forward as quickly as possible .
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in the sponsor's
application . For example, as set forth in the letter FDA sent to Duramed Research, Inc ., on
August 26, 2005, while the application sought approval for the switch for ages 16 and older,
CDER found that the data supported only for ages 17 and older . Moreover, the outcome of
FDA's rulemaking process may impact the approvability of the proposed packaging and the use of
age as a criterion on which to base a distinction between OTC and prescription use . Accordingly,
Duramed may need to amend its supplemental application . Please note, however, that as FDA's
August 26 letter to Duramed describes, CDER has completed its scientific review of their pending
supplemental application .
The Agency has found that considerable misinformation has circulated about this_ application and
the reasons FDA has taken the actions it has to this point . So there will be no confusion about the
public statements FDA actually has made concerning the Barr/Duramed Plan B/OTC application,
in addition to the two letters to the sponsor mentioned above, we are enclosing copies of the two
press releases dated May 7, 2004, and August 26, 2005, that the Agency issued concerning this
application .
Thank you again for your continued interest in this matter . If we can be of further assistance,
please let us know . A similar copy of this letter has been sent to Representative Maloney .
Patrick Rona n
for Legislation
4 Enclosures
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Rockville MD 2085 7
The Honorable Carolyn B . Maloney

House of Representatives
Washington, D .C . 20510-321 4 MAR 2 2006
Dear Ms . Maloney :
Thank you for the letter of September 22, 2005, co-signed by Representative Joseph Crowley in
which you express your concerns about the Food and Drug Administration's (FDA or the Agency)
processing of the supplemental new drug application from Barr Laborato ri es (now owned by
Duramed Research, Inc .) that proposes to change the marketing status of the drug, Plan B, from
prescription only to over-the-counter (OTC) .
Your letter cites the 23-4 vote taken at . the joint advisory committee meeting in December 2003,
recommending that Plan B be sold OTC . Advisory committee opinions are only advisory in
nature and are not binding on the Agency. The final determination
.-on any new drug application
(NDA) always is the responsibility of FDA . It is up to the Agency to clarify any unanswered
questions that may remain after the close of an advisory committee meeting or that were identified
during the meeting, even though a vote may have been taken on the main question(s) before the
committee . The busy schedules of the committee members require that advisory committee
meetings be scheduled well in advance. We certainly value the input from advisory committee
members and the opportunity to hear an exchange of ideas on proposed new products from experts
FDA is charged by Congress with reviewing new drug applications to determine a proposed new
product's safety and effectiveness for the uses put forth by the manufacturer in the application .
As a science-based agency, it is FDA that must make that final determination
.__ . ~ ._ ._ : _on whether
_ .~.,~~ .. ... . .>.at_,,....,
n .. .
d .aplictonfrduaeqtlymonsraehtdpsenuorthpse
uses stated by the manufacturer in the proposed labeling . A product cannot be approved until
FDA determines that the product is safe and effective for the indications
_ stated in. .the _,_ . proposed
labeling.
that time because : I) adequate data were not provided to support a conclusion that young
Page 2 - The Honorable Carolyn B . Maloney

review . This message was conveyed to the sponsor by the Acting Director of FDA's Center fo r
Drug Evaluation an d Research (CDER) with a full explanation of the reasons behind FDA's
(www .fda .gov/cder/drug/infopage/planB NALetter.pdf) .
.__ . .
That decision by the Acting Director of CDER was made after full review ._ . ._ ... ._of. .all
,_._the
. . underlying
data and an alysis and after discussions with all of the approp riate Agency personnel This
sufficient information about whether younger adolescent women ~ . __ could
._ understand the label an d
use the product safely and effectively for emergency_ contraception without the p r_of _ essional
Plan B an OTC product for women age 16 and over, and to have it remain presc ri ption only for
women under age 16 . The company also sought to market Plan B . in , a single package, and sold
either as prescription only or OTC, depending on the age of the :p u.rcYiaser.
In August 2005, FDA wrote a letter to the Duramed Research, Inc., (copy enclosed and available
at: http ://www .fda .gov/cder/drug/infopage/p1anB/Plan_B_Ietter20050826 .pdf) stating that FDA
had completed its review of the application and that the scientific data supported the safe and
effective use of Pl an B as an OTC product for women ages 17 and over. FDA also stated,
In the le tt er to the sponsor, FDA identified three difficult and novel issues presented by the
Rulemaking ( ANPRM) in the Federal Register seeking comment .-on : _ questions related to sectio n
503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Titl , e 21, United States Code
353(b)) . The questions the interested pa rties were asked to respond to conce rn when an active
ingredient of a drug may be simultaneously marketed as both a presc ri ption and as an OTC drug
product, whether and how OTC availability of a product c ould be restri cted to a part icular
subpopulation, and whether the same packaged product could be sold either as prescription only or
OTC, depending on the age of the purchaser. A related conce rn is how, as a practical matt er, an
age-based distinction could be enforced .
Page 3 - The Honorable Carolyn B . Maloney
As the Agency has said many times during the course of the review of this application, the
of November 1, 2005, and FDA is reviewing the comments and letters it received . While,we
application . For example, as set forth in the letter FDA sent to Duramed Research, In ., on
The Agency has found that considerable misinformation has circulated about this application and
application .
Thank you again for your continued interest in this matter. If we can be of further assistance,
please let us know . A similar copy of this letter has been sent to Representative Crowley.
Sincerely ,
Patrick Rona n
for Legislation
4 Enclosures
Tungrrss of f4P Umfrb OfafPs
tts 4ingtnn, 11C
September 22, 2005
Dr . Lester Crawford, Commissioner

Room 147 1
Dear Dr . Crawford :
We write as representatives of many New York women who are severely disappointed
with the Food and Drug Administration's (FDA) continued delay tactics on Plaii; B(r), a
concentrated dosage of ordinary birth control pills that, if taken within 72 hours lpf
contraceptive failure or unprotected sex, can reduce a woman's risk of pregnancy-by up to
89 percent . We are concerned that your agency's August 26th, 2005 decision to delay
issuing a final ruling on Plan B(r) as an over-the-counter (OTC) medication is ,
endangering the reputation of the FDA and having a direct and irreversible effect on the
health and well-being of thousands of women . Americans have long relied on the .FD A
to make scientific, evidence-based decisions that are in the best interest of the American
public and that will help improve our health. The decision to withhold Plan B(ry from
OTC use and limit its access when it has been deemed safe and effective for this purpos e
is not in the best interest of the American public .
While the FDA imposed 60-day comment pe riod may appear brief and harmless,'the
reality is that this 60-day period is in addition an already extended process . As you r~`jy
recall, on December 16, 2003 a joint panel of the FDA's Rep roductive Health Drugs . ;~
Advisory Committee and Non-prescription Drugs Advisory Committee voted 28=0 that
Plan B(r) could be safely sold as an over-the-counter medication ; it then voted 23-4 3" °
recommend that the FDA approve the application to make Plan B(r) available ._ over-the-
counter for women of all ages . At the beginning of 2005, the FDA declined to isque a
decision on the application by the pre-set deadline . A 60-day comment period in~ddition
to the previous delays appears to be excessive :
Based on the evidence and the history of this process, it appears that politics and
ideology has been allowed to influence sound science . The _recent
.~. _.announcement
by by the
Director of the Office of Women's Health, Susan-Wood, who resigned in August Citing
concerns about Plan B(r), is evidence of this serious problem . Specifically, she noted that
"scientific and clinical evidence" is effectively being "overruled ." This is a dangerous
path to tread .
The reasons for approving Plan B(r) for over-the-counter use remain the same . Millions
of women have successfully used Plan B(r) . Plan B(r) does not result in more frequent
usage or more unprotected sex . However, Plan B(r) will result in fewer abortions and
unintended pregnancies . Moreover, as determined by the expert panels, Plan B(r) meets
the requirements to be available OTC as extensive evidence shows that Plan B(r) is safe
and effective for OTC use .
PRINTED ON RECYC LED PAPER
~o ~-_ lj tl~O
Dr . Lester Crawford
September 22, 2005
Page 2
The data proves that this product should be made available for OTC use . Americans rely
on the FDA to protect them from harm. They must also be able to rely on the FDA to
protect them from part isan politics that could prevent them from accessing the best
available care . We encourage you to act on this issue and make Pl an B(r) available for
OTC use .
Sincerely,
Caroly&B . Malone
Member of Congress
i,_
J+~ssmc~,,,~ '
a f
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
. ''t► ~~o
Rockville MD 20857
The Honorable Joseph I . Lieberman

United States Senat e
Washington, D .C . 20510-070 3 FEB ? 7 20a1~
Dear Senator Lieberman :
Thank you for the letter of October 24, 2005, on behalf of several of your constituents in
Connecticut . The constituents express concerns about the Food and Drug Administration's (FDA
or the Agency) processing of the supplemental new drug application from Barr Laboratories (now
owned by Duramed Research, Inc .) that proposes to change the marketing status of the drug ,
Plan B, from prescription only to over-the-counter (OTC) .
As you know, FDA is charged by Congress with reviewing new drug applications (NDA) to
determine a proposed new product's safety and effectiveness for the uses put forth by the
manufacturer in the application . As a science-based agency, it is FDA that must make that final
determination on whether an application for a product adequately demonstrates that the data
presented supports the proposed uses stated by the manufacturer in the proposed labeling . A
product cannot be approved until FDA determines that the product is safe and effective for the
indications stated in the proposed labeling .
Some individuals have referenced the 23-4 vote taken at the joint advisory committee meeting in
December 2003, recommending that Plan B be sold OTC . Advisory committee opinions are only
advisory in nature and are not binding on the Agency, since the final determination on any NDA
always is the responsibility of FDA . It is up to the Agency to clarify any unanswered questions
that may remain after the close of an advisory committee meeting or that were identified during
the meeting, even though a vote may have been taken on the main question(s) before the
committee . The busy schedules of the committee members require that advisory committee
meetings be scheduled well in advance . We certainly value the input from advisory committee
members and the opportunity to hear an exchange of ideas on proposed new products from experts
prescription only to OTC . In May of 2004, FDA completed its first review of the NDA to switch
Plan B to OTC, and concluded that the application could not be approved at that time because : 1)
adequate data were not provided to support a conclusion that young adolescent women can safely
and effectively use Plan B for emergency contraception without the professional supervision of a
Page 2 - The Honorable Joseph I . Lieberma n
licensed practitioner, and 2) an amended proposal submi tted by the sponsor during the review
cycle to change the requested indication to allow for marketing of Plan B as a presc ription only
product for women under 16 years of age and a non-presc ri ption product for women 16 years an d
older was incomplete an d inadequate for a full review . This message was conveyed to the
sponsor by the Acting Director of FDA's Center for Drug Evaluation and Research ( CDER) with a
full expl anation of the reasons behind FDA's decision in a Not Approvable le tter dated May 6,
2004, (copy enclosed) an d available online at :
(wwrv .fda .gov/cder/drug/infopage/planB NALetter .pdf) .
That decision by the Acting Director of CDER was made after full review of all the underlying
data and an alysis and after discussions with all of the approp ri ate agency personnel . This
use the product safely an d effectively for emergency contraception without the professional
approval of the su.pplement . In its Not Approvable letter to the sponsor, FDA outlined some
issu an ce of a Not Approvable letter did not mean that a supplemental application could not or
In July 2004, the drug's sponsor amended its supplemental application seeking to make Plan B an
OTC product for women age 16 and over, and to have it remain prescription only for women
under age 16 . The company also sought to market Plan B in a single package, and sold either as
prescription only or OTC, depending on the age of the purchaser .
In August 2005, FDA wrote a letter to the Duramed Research, Inc ., (copy enclosed and available
at : http ://www.fda .gov/cder/drug/infopage/planB/Plan_B letter20050826 .pdJ) stating that FDA
effective use of Plan B as an OTC product for women ages 17 and over . FDA also stated,
In the letter to the sponsor, FDA identified three difficult and novel issues presented by the
503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21, United States Code '' .
353(b)) . The questions the interested parties were asked to respond to concern when an active
ingredient of a drug may be simultaneously marketed as both a prescription and as an OTC drug
product, whether and how OTC availability of a product could be restricted to a particular
subpopulation, and whether the same packaged product could be sold either as prescription only or
OTC, depending on the age of the purchaser . A related concern is how, as a practical matter, an
As the Agency has said many times du ring the course of the review of this application, the
questions that FDA was asked to answer, an d the proposal that was put forward by the sponsor,
Page 3 - The Honorable Joseph I . Lieberman
Although the Agency typically solicits public comment for a minimum of 90 . days when initiating
thi s this type of process, in the interest of moving quickly on this issue, the comment period was
of November 1, 2005, and FDA is reviewing the comments and letters it received . While we
application. For example, as set forth in the letter FDA sent to Duramed Research, Inc ., on
age as a criterion on which to base a distinction between, OTC and prescription use . Accordingly,
the reasons FDA has taken the actions it has to this point. So there will be no confusion about the
application .
Thank you again for your interest in this matter . If we can be of further assistance, please let us
know .
Sincerely ,
C/Patrick Rona n
Associate Comm i ss i oner
for Legislation
4 Enclosures
DEPARTMENT OF . HEALTH & HUMAN SERVICES Public Health Service
s J
c 1.~
~''f► ~.,a
Food and Drug Adminisfratiori
Rockville MD 20857
The Honorable Diana DeGette

Co-Chair, Bipartisan Pro-Choice Caucus
House of Representative s
Washington, D .C . 20515-060 1 MAR. 2 200 6
Dear Ms . DeGette :
Thank you for the letter of September 8, 2005, co-signed by the three other Co-chairs of the
Bipartisan Congressional Pro-Choice Caucus . You express concerns about the Food and Drug
Administration's (FDA or the Agency) processing of the supplemental new drug application from
Barr Laboratories (now owned by Duramed Research, Inc .) that proposes to change the marketing
status of the drug, Plan B, from prescription only to over-the-counter (OTC) .
Your letter referenced the 23-4 vote taken at the joint advisory committee meeting in December
2003, recommending that Plan B be sold OTC . Advisory committee opinions are only advisory
in nature and are not binding on the Agency . The final determination on any new dru g
application (NDA) always is the responsibility of FDA . It is up to the Agency to clarify any
unanswered questions that may remain after the close of an advisory committee meeting or that
were identified during the meeting, even though a vote may have been taken on the main
question(s) before the committee. The busy schedules of the committee members require that
advisory committee meetings be scheduled well in advance . We certainly value the input from
advisory committee members and the opportunity to hear an exchange of ideas on proposed new
products from experts in their respective scientific fields . It should not be presumed, however,
that a favorable vote by an advisory committee automatically means that a product is ready to go
to the pharmacy shelves .
As you know, FDA is charged by Congress with reviewing new drug applications (NDA) to
determine a proposed new product's safety and effectiveness for the uses put forth by the
manufacturer in the application . As a science-based agency, it is FDA that must make that final
determination on whether an application for a product adequately demonstrates that the data
presented supports the proposed uses stated by the manufacturer in the proposed labeling . A
product cannot be approved until FDA determines that the product is safe and effective for the
indications stated in the proposed labeling.
that time because : 1) adequate data were not provided to support a conclusion that young
i
Page 2 - The Honorable Diana DeGett e

review . This message was conveyed to the sponsor by the Acting Director of FDA's Center for
Drug Evaluation and Research (CDER) with a full explanation of the reasons behind FDA's
(www .fda .gov/cder/drug/infopage/planB_NALetter .pdf ) .
data and analysis and after discussions with all of the appropriate Agency personnel . This
use the product safely and effectively for emergency contraception without the professional
Plan B an OTC product for women age 16 and over, and to have it remain prescription only for
women under age 16 . The company also sought to market Plan B in a single package, and sold
either as prescription only or OTC, depending on the age of the purchaser .
at : http ://www.fda .gov/cder/drug/infopage/p1anB/Plan_B le1ter20050826 .pdf) stating that FDA
effective use of Plan B as an OTC product for women ages 17 and over . FDA also stated,
Rulemaking ( ANPRM) in the Federal Register seeking comment on questions related to section
503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act ( Title 21, United States Code
353(b)) . The questions the interested pa rt ies were asked to respond to concern when an active
ingredient of a drug may be simultaneously marketed as both a presc ri ption and as an OTC drug
product, whether and how OTC availability of a product could be rest ri cted to a pa rticular
subpopulation, and whether the same packaged product could be sold either as presc ription only or
OTC, depending on the age of the purchaser . A related conce rn is how, as a practical ma tter, an
i
Page 3 - The Honorable Diana DeGette
of November 1, 2005, and FDA is reviewing the comments and letters it received . While we
application. For example, as set forth in the letter FDA sent to Duramed Research, Inc ., on
application.
Thank you again for your interest in this matter . If we can be of further assistance, please let us
know . A similar response is being sent to each of the other co-signers of your letter .
Sincerely,
Patrick Ronan
for Legislation
4 Enclosures
COMMITlEES :
MEL MARTINEZ
FLORIDA V(:4" AGIN G
BANKING
(202)224-3041
V10 ENERGY AND NATURAL RESOURCES
'United ol3tates eStnate ~ o0 FOREIGN RELATION S
WASHINGTON, DC 20510-0 90 6
June 12, 200 6
Mr. Amit Sachde v

Associate Commissioner for Legislation
Food And Drug Administration
Parklawn Buildin g
5600 Fishers Lane, Room1547
Rockville, Maryland 20857
Mr . Mintz is concerned about over-the-counter approval of "Plan B" emergency

contraception . I am enclosing his correspondence for your review . Please address your response
to him directly .
Thank you for your attention to this matter . Please do not hesitate to contact me with any
questions or comments .
Sincerely,
Mel Martinez
United States Senato r
MM/tlm
Enclosure
2o0(oi ~3~3
Correspondence Tracking Sheet
Tracking # 170061-D C
Category : Social Religious

Campaign / Group : Plan B
Assigned To : Terrance Massey
Status : Open
Received Via : Web
Date Received : 03/25/200 6
Web Mail Subject : oming After P11" an~ the FDA"` "'"
Dear Senator Martinez,
As a constituent, I urge you to do all in your power to make sure that the FDA
makes the "morning after pill" available without a prescription and without
further delay . "
Thank Yo u
Notes/Comments :
Route History :
06/12/2006 - 04 :32 PM - Terrance-Massey - Printed Tracksheet
6/12/2006 11 :26 :23 AM - Gina Piek - Updated via Modify Fields
6/12/2006 11 :26 :23 AM - Gina Piek - Assigned to Terrance Massey
5/9/2006 1 :29 :00 PM - Jenn Gallagher - Updated via Modify Field s
- b/9/20061 :29 :00 PM -Jenn Gallagher - Assigned to Frank C. Walker------ -- '
03/27/2006 04 :18 :14 PM - Created manually by Jenn Gallagher via lnterTrac WebMail .
InterTrac Tracksheet 01 1 06 1 12/2006

DEPARTMENT OF HEALTH & HUMAN SERVICES

Rockville MD 2085 7
b
JUL 1 1 200 6
Thank you for your letter of June 12, 2006, addressed to Senator Mel Martinez regarding
the processing, by the Food and Drug Administration (FDA or the Agency), of the
supplemental new drug application (NDA) from Barr Laboratories (now owned by Duramed
Research, Inc .) that proposes to change the marketing status of the drug, Plan B, from
prescription only to over-the-counter (OTC) . Senator Martinez has -asked us to respond
directly to you.
FDA is charged by Congress with reviewing NDAs to determine a proposed new product's
safety and effectiveness for the uses put forth by the manufacturer in the application . As a
science-based agency, it is FDA that must make that final determination on whether, an , . ., .
application for a product adequately demonstrates that the data presented supports the
proposed uses stated by the manufacturer in the proposed labeling . A product cannot be
approved until FDA determines that the product is safe and effective for the indicati .ons .stated
in the proposed labeling .
Some individuals have referenced the 23-4 vote taken at the joint advisory committee meeting
in December 2003, recommending that Plan B be sold OTC . Advisory committee opinions
are only advisory in nature and are not binding on the Agency, since the final determination
on any NDA always is the responsibility of FDA . It is up to the Agency to clarify any
unanswered questions that may remain after the close of an advisory committee meeting or
that were identified during the meeting, even though a vote may have been taken on the main
question(s) before the committee . The busy schedules of the committee members require that
advisory committee meetings be scheduled well in advance . We certainly value the input
from advisory committee members and the opportunity to hear an exchange of ideas on
proposed new products from experts in their respective scientific fields . It should not be
presumed, however, that a favorable vote by an advisory committee automatically means that
a product is ready to go to the pharmacy shelves .
activities concerning the application of the sponsor, to change the marketing status of Plan B
Page 2- M P ip
from prescription only to OTC . In May of 2004, FDA completed its first review of the NDA
to switch Plan B to OTC, and concluded that the application could not be approved at that time
because : 1) adequate data were not provided to support a conclusion that young adolescent
women can safely and effectively use Plan B for emergency contraception without the
professional supervision of a licensed practitioner, and 2) an amended proposal submitted by the
sponsor during the review cycle to change the requested indication to allow for marketing of
Plan B as a prescription only product for women under 16 years of age and a nonprescription
product for women 16 years and older was incomplete and inadequate for a full review . This
message was conveyed to the sponsor by the then-Acting Director of FDA's Center for Drug
Evaluation and Research (CDER) with a full explanation of the reasons behind FDA's decision
in a Not Approvable letter dated May 6, 2004, (copy enclosed) and available online at :
(www.fda.gov/cder/drug/infopage/p1anB-NALetter.pd. f)
decision was based on his assessment that the data in the supplemental application did not
contain sufficient information about whether younger adolescent women could understand the
label and use the product safely and effectively for emergency contraception without the
professional supervision of a licensed practitioner . Therefore, the data in the application did not
support approval of the supplement . In its Not Approvable letter to the sponsor, FDA outlined
some additional information that would be required for approval to market Plan B as an OTC
drug . The issuance of a Not Approvable letter did not mean that a supplemental application
could not or would not be approved in the future .
In July 2004, the drug's sponsor amended the supplemental application seeking to make Plan B
an OTC product for women age 16 and over, and to have it remain prescription only for women
under age 16 . The company also sought to market Plan B in a single package, and sold either as
prescription only or OTC, depending on the age of the purchaser.
In August 2005, FDA wrote a lett er to the Duramed Research, Inc ., (copy enclosed and available
at : http://www.fda .gov/cder/drug/infopage/p1anB/Plan-B Ietter20050826 .pdf) stating that FDA
had completed its review of the application and that the scienti fi c data supported the safe and
effective use of Pl an B as an OTC product for women ages 17 and over. FDA also stated,
however, that it was unable at that ti me to reach a fi nal decision on the approvability of the
application, issues for which the Agency is committed to a process for resolving . That
process was initiated with the publication on September 1, 2005, of an Advance Notice of
Proposed Rulemaking (ANPRM) in the Federal Register seeking comment on questions related
to section 503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21, United States
Code 353(b) . The questions the interested parties were asked to respond to concern when an
active ingredient of a drug may be simultaneously marketed as both a prescription and as an
OTC drug product, whether and how OTC availability of a product could be restricted to a
particular subpopulation, and whether the same packaged product could be sold either as
prescription only or OTC, depending on the age of the purchaser . A related concern is how, as a
practical matter, an age-based distinction could be enforced .
Page 3 - M
active ingredient can simultaneously be marketed in both a prescription drug product and an
OTC drug product for the same indication, strength, dosage form and route of administration .
Although the Agency typically solicits public comment for a minimum of 90 days when
initiating this type of process, in the interest of moving quickly on this issue, the comment period
was shortened to 60 days for this ANPRM . The public comment period on these questions
closed as of November 1, 2005, and FDA is reviewing the comments and letters it received .
While we cannot put an exact timeline on how long it will take to process these comments, we
are committed to moving forward as quickly as possible .
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in the
sponsor's application . For example, as set forth in the letter FDA sent to Duramed Research,
Inc ., on August 26, 2005, while the application sought approval for the switch for ages 16 and
older, CDER found that the data supported only for ages 17 and older . Moreover, the outcome
of FDA's rulemaking process may impact the approvability of the proposed packaging and the
use of age as a criterion on which to base a distinction between OTC and prescription use .
Accordingly, Duramed may need to amend its supplemental application : Please note, however,
that as FDA's August 26 letter to Duramed describes, CDER has completed its scientific review
of their pending supplemental application .
the reasons FDA has taken the actions it has to this point . So there will be no confusion about
the public statements FDA actually has made concerning the Barr/Duramed Plan B/OTC
application, in addition to the two letters to the sponsor mentioned above, we are enclosing
copies of the two press releases dated May 7, 2004, and August 26, 2005, that the Agency issued
concerning this application .
Thank you again for contacting Senator Martinez conce rning in this matter.
avid W . Boyer
for Legislation
4 Enclosure s
cc : The Honorable Mel Martinez

United States Senate
Washington, D .C . 20510-0906
I
COMMRTEES
MEL MARTINEZ
FLORIDA AGING
(202)224-3041 BANKING
ENERGY AND NATURAL RESOURCE :
"United ~$ tates $enate FOREIGN RELATIONS
WASHINGTON, DC 20510-0906
April 26, 200 6
Mr . Amit Sachde v
Associate Commissioner for Legislation
Food And Drug Administration
Parklawn Building
5600 Fishers Lane, Room1547
Rockville, Maryland 2085 7
Dear Mr . Sachdev :
V'-
I am contacting you on behalf of my constituent, Ms ~ ~
Ms .doconcerned about availability of Plan B over the counter . I am enclosing her

correspondence for your review . Please address your response to her directly .
Thank you for your attention to this ma tter . Please do not hesitate to contact me with any
questions or comments .
Sincerely,
Mel Martinez
United States Senato r
MM/jcg
Enclosure
CC~- k -- yG/' e
~
MEL MARTINEZ COMMITTEES :
FLORIDA AGIN G
(202) 224-304 1 BANKING
ENERGY AND NATURAL RESOURCE:
United ~*tate~ Xnce Tracking Sheet
FOREIGN RELATION S
RSHINGTON, DC 20510 -0906
Tracking # 149509-D C
Category : Social Religious

Campaign / Group : Buck to FDA
Assigned To : Jenn Gallaghe r
Status : Open
Received Via : Web
Date Received : 02/01/2006
Web Mail Subject : FDA
Please give me information when Plan B will be given final approval . It

has been approved and what is the hold up .
w IS T~' _ *
Notes/Comments :
Route History :
04/26/2006 - 03 :46 PM - Jenn Gallagher - Printed Tracksheet
3/13/2006 5 :29:45 PM - Brianne Jablon - Assigned to Jenn Gallagher
02/01/2006 02 :13 :31 PM - Created manually by Coy Neal via lnterTrac WebMail .
InterTrac Tracksheet 01 1 04/26/2006
<:
4rilc[r..
DEPARTMENT OF HEALTH -& HUMAN SERVICES

•0 ~
~~~►~~o Food and Drug Administration
Rockville MD 2085 7
JUN 0 9 200 6
Dear M
Thank you for your letter, of April 26, 2006, addressed to Senator Mel Martinez,
concerning the processing by the Food and Drug Administration (FDA or the Agency) of the
supplemental new drug application (NDA) from Barr Laboratories (now owned by Duramed
Research, Inc .) that proposes to change the marketing status of the drug, Plan B, from
prescription only to over-the-counter (OTC) . Senator Martinez asked that we respon d
directly to you.
FDA is charged by Congress with reviewing new drug applications to determine a proposed
new product's safety and effectiveness for the uses put forth by the manufacturer in the
application . As a science-based agency, it is FDA that must make that final determination on
whether an application for a product adequately demonstrates that the data presented supports
the proposed uses stated by the manufacturer in the proposed labeling . A product cannot be
approved until FDA determines that the product is safe and effective for the indications stated
in the proposed labeling.
Some individuals have referenced the 23-4 vote taken at the joint advisory committee meeting
in December 2003, recommending that Plan B be sold OTC . Advisory committee opinions
are only advisory in nature and are not binding on the Agency . The final determination on
any NDA always is the responsibility of FDA . It is up to the Agency to clarify an y
unanswered questions that may remain after the close of.an advisory committee meeting or
that were identified during the meeting, even though a vote may have been taken on the main
question(s) before the committee . The busy schedules of the committeemembersrequire that
advisory committee meetings be scheduled well in advance . We certainly value the input
from advisory committee members and the opportunity to hear an exchange of ideas o n
proposed new products from experts in their respective scientific fields . It should not be
presumed, however, that a favorable vote by an advisory committee automatically means that
a product is ready to go to the pharmacy shelves.
from prescription only to OTC . In May of 2004, FDA completed its first review of the ND A
~ ..<~
Page 2 - M
to switch Plan B to OTC, and concluded that the application could not be approved at that time
because: 1) adequate data were not provided to support a conclusion that young adolescent
professional supervision of a licensed practitioner, and 2) an amended proposal submitted by the
sponsor during the review cycle to change the requested indication to allow for marketing of
Plan B as a prescription only product for women under 16 years of age and a non-prescription
message was conveyed to the sponsor by the then Acting Director of FDA's Center for, Drug
Evaluation and Research (CDER) with a full explanation of the reasons behind FDA's decision, .,
: .inaNotAprvble datMy6,204(copenlsd)avibeonlat
(www.fda.gov/cder/drug/infopage/p1anB_NALetter.pdf)
professional supervision of a licensed practitioner . Therefore, the data in the application did not
drug. The issuance of a Not Approvable letter did not mean that a supplemental application
In July 2004, the drug's sponsor amended the supplemental application seeking to make
Plan B an OTC product for women age 16 an d over, and to have it remain presc ription only for
women under age 16 . The company also sought to market Pl an B in a single package, and sold
either as presc ri ption only or OTC, depending on the age of the purchaser .
at: http ://www.fda.gov/cder/drug/infopage/p1anB%Plan B_letter20050826 .pdf)
stating that FDA had completed its review of the application and that the scientific data
supported the safe and effective use of Plan B as_ an_ OTC product for women ages 17 and over .
FDA also stated, however, that it was unable at that time to reach , a,f nal decision onathe
approvability of the application due to unresolved issues that related to the application .
503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21, United States Code
353(b) . The questions the interested parties were asked to respond to concern when an active
ingredient of a drug may be simultaneously marketed as both a prescription and as an OTC drug
product, whether and how OTC availability of a product could be restricted to a particular sub-
population, and whether the same packaged product could be sold either as prescription only or
OTC, depending on the age of the purchaser . A related concern is how, as a practical matter, an
Page 2- M lo
An ANPRM is a mechanism to ask for public comments on whether, :the Agency should initiate a
active ingredient can simultaneously be marketed in both a prescription drug product and an
OTC drug product for the same indication, strength, dosage form and route of administration .
Although the Agency typically solicits public comment for a minimum of 90 days when
closed as of November 1, 2005, and FDA is reviewing the comments and letters it received.
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in the . . . .
sponsor's application. For example, as set forth in the letter FDA sent to Duramed Research,
use of age as a criterion on which,to base a distinction between OTC and prescription use .
Accordingly, Duramed may need to amend its supplemental application . Please note, however,
as FDA's August 26 letter to Duramed describes, CDER has completed its scientific review of
their pending supplemental application .
the reasons FDA has taken the actions it has to this point . So there will be no confusion about
the public statements FDA actually has made concerning the Barr/Duramed Plan B/OTC
application, in addition to the two letters to the sponsor mentioned above, we are enclosing
copies of the two press releases dated May 7, 2004, and August 26, 2005, that the Agency issued
Thank you again for contacting Senator Martinez concerning this matter.
Sincerely,
~
avid W . Boyer -
Assistant Commissioner
for Legislation
4 Enclosures
• S C C
Page 2 - M
cc : The Honorable Mel Martinez

United States Senate
Washington, D .C . 20510-0906
!
-anifeb .W af:e.W .-%-excU#C,

Ted Stevens President Pro Tempore Chaiman
Commerce, Science, and Transportatio n
Alaska Washington, DC 20510
(202) 224-3004 Appropriations
(202) 224-2354 (Fax) Governmental Affairs
Rules and Administration
Library of Congress
March 27, 200 6
Amit Sachdev
Associate Director for Legislative Affairs
Food and Drug Administratio n
6600 Fishers Lane
Rockville, Maryland 2085 7
Dear Amit :
11~ ■
Enclosed is a copy of an email I received fro -
would appreciate an ' ation that you can provide me regarding Plan B, so that t may
would
respond to Ms
Please direct any questions you may have in regard to this inquiry to Nicolia
Demopoulos on my staff : Replies to this correspondence should be sent to : P .O . Box
1766, Washington, DC 20013 . Thank you for your assistance .
With best wishes,
Cordially ,
TED STEVEN S
Anchorage Fairbanks Juneau Wasilla Kenai SetcLikan .,. _ . ._. __ _ _ Bethel

.- ..-
., .
(907) 271-5915 (907) 456-0261 (907) 586-7400 (907) 376-7665 (907) 283-5808 (907) 225-6880 (907) 543-1638
d006 - 3 ai y
x
From :
Sent : u , ovember 15, 20 0
To : senator_stevens@exchange .senate .gov
Subject : CF-MAI L
OI„, I C -~'
<IP>209 .112 .152 .119</IP>

<PREFIX>Ms .</ FIX>
<FIRSTNAME>~FIRSTNAME >
<LASTNAME> E>
<ADDRESS1 > ADDRESS1 >
<ADDRESS / ADDRESS2>
<CITY> </CITY> k
<STATE STATE >
<ZIP> /Z
(~
<HOME ONE> 9
<WORKPHONE></WORKP
<EMAIL> kJffMNWMKAIL> _
<SUBJE erc .SUBJECT>
<MESSAGEBODY>FDA . . . The new stories in the Anchorage Daily News about the FDA and plan B
are very worrisome to me . The FDA did not listen to their own advisory committees
recommendation . Descisons on new drugs must not be politically influenced . I applaud Dr
Susan Wood and her clourage to resign in protest . Please look into this issue . Howl
personally feel about the Plan b is not important . It is the process and this must be
based on science and the FDA must be credibile in its decisions .</MESSAGEBODY>
<AddressTo>General</AddressTo>
1
DEPARTMENT OF HEALTH 8i HUMAN SERVICE S
x ~ .
~.,
~i~17a
Food an d Dr
ugAdministratio
n
Rockville MD 20857
The Honorable Ted Stevens

United States Senate MAY :- 4 zo06
Post Office Box 1766
Washington, D .C . 2001 3
Dear Senator Stevens :
e letter of March 27, 2006, on behalf of your constituent, Ms .

Ms . IM expresses concerns about the processing, by the Food and Drug
Administration's (FDA or the Agency), of the supplemental new drug application from
Barr Laboratories (now owned by Duramed Research, Inc .) that proposes to change the
marketing status of the drug, Plan B, from prescription only to over-the-counter (OTC) .
FDA is charged by Congress with reviewing new drug applications (NDA) to determine a
proposed new product's safety and effectiveness for the uses put forth by the manufacturer in the
application . As a science-based agency, it is FDA that must make that final determination on
whether an application for a product adequately demonstrates that the data presented supports the
proposed uses stated by the manufacturer in the proposed labeling . A product cannot be
approved until FDA determines that the product is safe and effective for the indications stated in
the proposed labeling.
Some individuals have referenced the 234 vote taken at the joint advisory committee meeting in
December 2003, recommending that Plan B be sold OTC . Advisory committee opinions are
only advisory in nature and are not binding on the Agency, since the final determination on any
NDA always is the responsibility of FDA . It is up to the Agency to clarify any unanswered
questions that may remain after the. close of an advisory committee meeting or that were
identified during the meeting, even though a vote may have been taken on the main question(s)
before the committee . The busy schedules of the committee members require that advisory
committee meetings be scheduled well in advance . We certainly value the input from advisory
committee members and the opportunity to hear an exchange of ideas .on proposed new products
from experts in their respective scientific fields . It should not be presumed, however, that a
favorable vote by an advisory committee automatically means that a product is ready to go to the
pharmacy shelves .
from prescription only to OTC . In May of 2004, FDA completed its first review of the NDA to
switch Plan B to OTC, and concluded that the application could not be approved at that time
because : 1) adequate data were not provided to support a conclusion that young adolescent
Page 2 - The Honorable Ted Stevens
professional superv ision of a licensed practitioner, and 2) an amended proposal submi tted by the
sponsor du ring the review cycle to ch an ge the requested indication to allow for marketing of
Plan B as a presc ription only product for women under 16 years of age an d a nonprescription
message was conveyed to the sponsor by the then-Acting Director of FDA's Center for Drug
Evaluation an d Research (CDER) with a full explanation of the reasons behind FDA's decision
in a Not Approvable le tter dated May 6, 2004, (copy enclosed) and available online at :
(www.fda .gov/cder/drug/infopage/planB 1VALetter.pdf) .
data and analysis and after discussions with all of the appropriate agency personnel . This
professional supervision of a licensed practitioner. Therefore, the data in the application did not
drug . The issuance of a Not Approvable letter did not mean that a supplemental application
In July 2004, the drug's sponsor amended the supplemental applica tion seeking to make Plan B
an OTC product for women age 16 and over, and to have it remain presc ription only for women
under age 16 . The comp an y also sought to market Plan B in a single package, and sold either as
presc ri ption only or OTC, depending on the age of the purchaser.
In August 2005, FDA wrote a lett er to the Duramed Research, Inc ., (copy enclosed and available
at: http .//www.fda .gov/cder/drug/infopage/p1anB/PlanBIetter200S0826.pdJ) stating that FDA
had completed its review of the application and that the scientific data suppo rted the safe and
effective use of Pl an B as an OTC product for women ages 17 and over . FDA also stated,
Rulemaking (ANPRM) in the Federal Register seeking comment on questions related to
section 503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21, United States
Code 353(b)) . The questions the interested parties were asked to respond to concern when an
active ingredient of a drug may be simultaneously marketed . as both a prescription and as an
OTC drug product, whether and how OTC availability of 'a' product could be restricted to a
particular subpopulation, and whether the same packaged product could be sold either as
prescription only or OTC, depending on the age of the purchaser . A related concern is how, as a
practical matter, an age-based distinction could be enforced .
Page 3 - The Honorable Ted Steven s
active ingredient can simultaneously be marketed in both a prescription drug product and an,
OTC drug product for the same indication, strength, dosage form and .route of administration .
Although the Agency typically solicits public comment for a minimum of 90 days whe n
closed as of November 1, 2005, and FDA is reviewing the comments and letters it received .
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in the
sponsor's application . For example, as set forth in the letter FDA sent to Duramed Research,
use of age as a criterion on which to base a distinction between OTC and prescription use .
Accordingly, Duramed may need to amend its supplemental application . Please note, however,
that as FDA's August 26 letter to Duramed describes, CDER has completed its scientific review
of their pending supplemental application .
the reasons FDA has taken the actions it has to this point. So there will be no confusion about
the public statements FDA actually has made concerning the BarrlDuramed Plan B/OTC
application., in addition to the two letters to the sponsor mentioned above, we are enclosing
copies of the two press releases dated May 7, 2004, and August-26, 2005, that the Agency issued
Thank you again for contacting us concerning this matter . If you have further questions, please
let us know.
S . cerely ,
David W . Boyer
Assistant Commissione r
for Legislation
4 Enclosures
vv r a%l :a' rn11 1
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TOM DAVIS, VIR<a1N1A HENRY A . WA7Q,WH, CALIFORNIA.
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DAN SURTON. INDIANA MAJOR R. &AIDIS, NEW YORK
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IL@AiJA PAr-LE14TINEN. FLORIDA FJ7OLPHUB TOMS, NEW YORK
JONN M, MaNUGN,NEW YORK PAUL E. KAN:IORBKL PENNSYLVANIA
JONN L MICA: FLORIDA CAROLYN B. MALONEY.NEW YOR
GIL GUIXNECHT, MINNESOTA . CLMYNiCS, MARYLANDKENJMi
MARK S. BOUDER . INDIANA DENNIB J. KUCINCM, ONIO
STEVEN 0. LILTOURFM, OHIO
TODD RU66 19.6 PIATTB, PENNSYLVANIA
CHRIS CANNON, trtA N
J~ougr of Alpregentoibeg DANNY K, DAVIS, ILLINOIS
WK LACY CLAY. MIMOURI
DIANE E. WATSON, CALIFORNIA
JOHN J . DUNCAI4, aft, TENNES9EE 51FPNPJV F. LYNCH, MASSACHUSETTS
CANDICE MILLER, MICHIGA COMMITTEE ON GOVERNMENT REFORW CHRIS VAN FIOLLEN. MARYLAND
MNAMOURTNE,O LINDA T. SANCt¢Z CAUFORN w
DARABU. ISEA, QALIFORNIA C.A. DUTCH RUPPERBSERGER,
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KENNY MARCHANT, TE(A BRIAN ROBINS, NEW YOPo
A. WESTMOS96ANI;NBLYN GEORGIA WASHINGTON, DC 20515--6943 (EL ANORHOLMESNORTON,
PATRICK T . MsHENRY, NORTN CAROLINA DISTRICT OF COLI)MIN A
CHARLES W. DEW, PRWSYLVAr4A MouaertY = 22F0T6
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HttpJ/rAfortn.hoase.pov
March 9 ; 200 6
Honorable Andrew C . von Eschenbach, M .D .

Acting Commissioner
5630 Fishers Lane
Dear Dr . von Eschenbach:
The Food and Drug Administration appears to be seriously mischaracterizing its analysis
of the regulatory issues surrounding Plan B, the emergency contraception pill .
We already know that FDA created a regulatory "Catch 22" to justify the predetermined
political decision to block over-the-counter sales of Plan B . It was only after repeated urging
from the FDA itself --- despite a lack of scientific justification - that the manufacturer proposed
over-the-counter access to women s ixteen and over and prescription access for those younger .
Yet the agency then used these age restrictions to justify an, _,_indefinite delay, claiming that it...._.
needs more time to assess whether an. over-tlie-cotimter switch can Te resiricted based on age ;
how such a rest ri ction could be enforced ; and whether a product with a single package can
legally be marketed differently to different Y populations .
Previously undisclosed documents reveal that in addition to having created the situation it
now protests as too complex to solve, FDA has seriously mischaracterized its consideration of
the regulatory questions at stake . Despite FDA's claims that it needs time to analyze the "novel"
issues, the agency had apparently been considering them for at least a year before its August
"o
2005 decision to delay action : The documents also show that during is period, FDA's ffice
of Chief Counsel repeatedly brushed aside the requests of agency officials for a dispositiwe legal
analysis . In essence, the agency was well aware of the regulatory questions that would arise
when it suggested age restrictions, but simply did not resolve-them in a timely manner .
The documents I have obtained, along with continuing questioiis about FDA's document
retention policies, do not reflect well on FDA . They further undermine the agency's contention
that the Plan B decision was based on legitimate science-based factors . lain writing-to-askfor
an explanation of the new documents and FDA's actions .
,,)d
o~ -~ ~~'~ /
~X vr nt'.Y' m11V 1 0 00 3
-1

March 9 , 2006
Page 2
Background
Over the last several years, FDA repeatedly urged Plan B's sponsor, Barr Laboratories, t o
consider and propose age restrictions on over-the-counter access. Yet once Barr proposed such a'
plan, the agency claimed that the questions it raised were too difficult to solve .
Barr submitted an application to sell Plan B over the counter, without restrictions, in
April 2003 . A GAO investigation found that FDA suggested age restrictions in discussions with
the sponsor as early as September 2002 and again in October 1003 . 1 According to minutes of a
February 2004 meeting, FDA Commissioner Mark McClellan "diinected" FDA staff to "continue
to work with the sponsor on a marketing plan to limit availability of the product over the counter
and to consider the most appropriate age groups to be restricted from access to the product ."2
In March 2004, Barr submitted an amendment to its application, proposing a dual-

marketing plan with over-the-counter access for women sixteen and above, and prescription
access for those younger .
In May 2004, FDA issued a not-approvable letter to Barr Laboratories . FDA wrote that
the. March 2004 amendment proposing a dual-marketing plan was preliminary and incomplete,
and that therefore the agency had only reviewed the proposal to offer unrestricted over-the-
counter access . FDA then denied the application on the grounds that there was insufficient data
on use among women under sixteen, despite consensus among agency advisors and staff on the
public health benefit and safety of making Plan B more accessible . .5
In the May 2004letter, FDA told Barr that it could either submit more data on adolescent
safety or provide more information on the dual-miarketing approach : .
1 Government Accountability Office, Food and Drug Administration : Decision Process

to Deny Initial Applicatiorz for Over-the-Counter
,_ Marketing of the Emergency Contraceptiv e
Drug Plan B Was Unusual (GAO-06-109)W(Nov . 14, 20U5).
21d at 18 _
Letter from Steven Gals on, Acting Director, Center for Drug Evaluation and Research,
FDA, to Joseph A. Carrado, Senior Director, Regulatory Affairs, Barr Laboratories (May 7,
2004) (online at http ://www .fda.gov/eder/drug/infopage/p1anB/plarzB NALetter .pdf).
4
Id
FDA, Center for Drug Evaluation and Research, Nonprescription Drugs Advisory
Committee (NDAC) in Joint Session with the Advisory Committee for Reproductive Health
Drugs (ACRpID) Meeting (Dec . 16,2003) (online at http ://www fda.gov/ohrms/dockets
/ac/03/transcripts/4015T 1 .DOC) ; FDA : Plan B Sales 12ejected Again.rt Advice ; Official Denies
That Politics Blocked Contraceptive's Over-the-Counter Status, Washington Post (May 7, 2004) .
.av . i~cr ill I I N tQOO 4

March 9, 200 6
Page 3
[YJou could supply additional information in support of the revised indication to allow
for marketing of Plan B as a prescription-only product for women under the age of 16
years and a nonprescription product for women 16 years and older, including draft
product labeling. If you take the latter approach, your response to this letter would have
to include details of how you propose to implement simultaneous prescription and
nonprescription marketing of Plan B for women of different ages in a single packaging
configuration while complying with all relevant statutory and regulatory requirements for
labeling and marketing of this product . 6
In July 2004, Barr submitted an amended application with age restrictions . FDA
determined that the amended application constituted a complete response to the not approvable
letter .7
In August 2005, FDA announced an indefinite delay of action on the amended Plan B
application. Accordi ng to FDA, the amended application raised "difficult and novel" re gulatory
questions, and the agency therefore initiated a publi c comment peri od on whether FDA should
initiate a rulemsking .8 The agency told Barr Laboratories :
Your applicati on has presented us with three diffi cult and novel issues. Specifi cally, you
have proposed that Plan B be marketed in a single package, and sold either as Rx or
OTC, depending on the age of the patient . While the Agency has allowed the same active
ingredient to be marketed both Rx and OTC based on indication, strength, dosage form
and route of administrati on, the Agency has never determined whether a drug may be
both Rx and OTC based on the age of the individual using the drug . A related concern is
how, as a practical ma tter, an age-based distinction could be enforced . In addition, we
h ave never been confr onted with whether t he Rx and OTC versions of the same active
ingre dient may be marketed in a single package . 9
6 Letter from Steven Galson, supra note 3 .

7 Letter from FDA Commissioner Lester M . Crawford to Joseph A . Carrado, Senior
Director, Regulatory Affairs, Barr Laboratories (Aug . 26, 2005) ( oiiline at
httD ://www.fda .sEov/cder/drua/infoi)age/nlanB/Pl-a'n-
.~ pfj . The lette r
acknowledges that the submission on July 21, 2004 _"constituxed a complete response to our May
6, 2004 Not Approvable action letter. "
8 Food and Drug Administration, Advance Notice of Proposed Rulemakzng 21 CFA Part
310 [Docket No. 2005N-0345] Drug Approvals : Circumstances Under Which an Active
Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-
The-Counter Drug Product (Aug. 26, 2005) (online at
http ://www .fda .gov/bbs/topics/NEWS/2005/cd0584 .pdf) .
9 Letter from FDA Commissioner Lester M . Crawford, supra note 7 .
. . . . . . . .u - v - rrV -VU "V r 1[tCr mi n 1900 5
Honorable Andrew C . von Eschenbach, M.D .

March 9, 2006
Page 4
A statement by then-FDA Commissioner Lester Crawford expressed similar views :
The issues that we were asked to re solve, and the proposal that was put forward by Barr
Labs, presented us with many difficult and novel policy and regulatory issues . In some
cases, the questions we were asked to answer were unprecedented for this agency . . . .
What we are saying today is that the Agency is unable at this time to reach a decision on
the approvability of the application because of these unresolved regulatory and policy
issues that relate to the application we were asked to evaluate . . . . These rules have lots of
implications that aren't always easy to anticipate at first blush.' °
The questions that Dr . Crawford says the agency was "asked to answer" were purely a result of
the agency's actions . The very age restrictions that FDA had suggested for years had become the
agency's justification for indefinite delay on the Plan B application.
The New Documents
Documents that I have received call into question FDA's assertions about the "novelty"
-
of the regulatory questions raised by the dual -marketing plan . These documents show that policy
staff both analyzed and outlined potential solutions for the regulatory questions at least 15
months before FDA publicly claimed that the questions were so "novel" that they required an
indefinite delay . Furthermore, the documents indicate that FDA's Office of Chief Counsel was
aware of the relevant regulatory questions for at least as long, yet apparently failed to .complete a
dispositive legal analysis . In effect, it appears that FDA was not surprised by the regulatory
questions ; instead, it simply failed to complete an analysis that could have paved the way for
approval.
In April 2004, Jane Axelrad, Associate Director for Policy at FDA's Center for Drug
Evaluation and Research (CDLR), wrote to several colleagues, including then-Acting Director of
CDER Dr. Steven Galson (who signed the May 2004 not approvable letter) and Acting Deputy
Commissioner of Operations Dr . Janet Woodcock . The email stated, "A .ttached is a brief
summary of the results of our analysis of the issues associated with the Barr "proposal on Plan B .
As it has not been shared outside the Center, I would appreciate if you could keep it clos e
hold ."' 1 The memo attached to the email poses the question "If FDA finds that Plan B's
directions for use are adequate for safe and effective self -medication by women 16 and older, but
cannot similarly find the directions adequate for women under age 16, can FDA approve Ban's
proposal?"' Z
10 FDA, FDA Takes Action on Plan

...: -B; Statement
._ . .. _ ._ . _ by FDA Commissioner Lester M.
Crawford (Aug_ 26, 2005) (orihne at-
http ://www .fda.gov/bbs/topies/NEWS/2005/NEW01223 .html) .
Email from Jane Axelrad to FDA staff (Apr . 13, 2004) .
1z CDER, Plan B Proposal to Market Plan B as Joint O TC/.RX (Draft) .
.av . iijLo a• 1411v WJ 00 6
Honorable Andrew C . von Eschenbach, M.D .

March 9, 2006
Page 5
The memo reviews statutory and regulatory requirements and concludes

_, . .that "approval
would be consistent with precedent" and that "Rx and OTC Plan B could be marketed in the
same paclcage and comply with applicable statutory and regulatory provisions ."" It then
describes how Barr could comply with provisions related to package labeling, directions for use,
and advertising . 14 Based on Ms . Axelrad's email, this memo apparently represents only a
summary of a more detailed analysis conducted by CDER .
Other documents reve al that well before the August 2005 decision, agency ofFcials were
asking the Offi ce of Chief Counsel (OCC), which is the part of FDA that ultimately determines if
a particular course of action is lega lly sustainable, to assess the regulatory questions that a dual-
marketing plan would raise . In one of these documents, an April 1, 2004, review, a Deputy
Division Director noted that Commissioner McClellan and senior management had asked OC C
to assess a restricted distribution plan that would exclude adolescents :
FDA legal counsel was asked to assess whether the restrictions outlined are feasible
within the current regulato ry framework prior to taking the not-approvable action on this
[application] so that this distribution plan can be requested by the FDA withiri tlze non=
approval letter for future consideration in a re-submission .1 5
This review was apparently not completed by OCC. Minutes from a teleconference held
just prior to the May 2004 not approvable le tter indicate :
Barr's March 11, 2004 submission of a marketing plan for OTC availability for older
women and prescription for adolescents under 16 years was forwarded to the Office of
the Chief Counsel (OCC) but no final review was done . ' 6
In a May 14, 2004, email, Dr. John Jenkins, Director of the Office of New Drugs, wrote
to Dr . Galson, Dr. Woodcock, and other colleagues to set out a schedule for expeditious
consideration of the questions that would be raised by limiting over-the-co. =ter-access
. _. . to women
, . ,. R
16 and over . According to this email, the amended application would be subject to the
Prescription Drag User Fee Act (pDU1+A),whicli sets performance goals for FDA consideration
of drug applications . Dr . Jenkins wrote :
15 Deputy Division Director Summary Review

of New Drug Appl ication (NDA 21-045
49 (Apr. 1, 2004) .
16 CIDER, Meeting Notes of Internal Meeting on Not-Approvable Decision
("Teleconference Minutes ") (May 5, 2004) .
. a.uaauaa 1
Honorable Andrew C . von Esehenbach, M .D .

March 9, 2006
Page 6
_~ .
We will have a 6-month PDUFA clock for this Class 2 res .ubm .ission I would propose
that we will need to get OCC to agree to complete their review by the end of month 3, or
month 4 at the latest, so that there will be time in the review cycle to complete any
negotiations about any changes needed to the labeling ( assuming they find the proposal
legal), . . . I would hope that you and Janet [Woodcock] would coordinate with [Chief
Counsel] Dan Troy to have OCC continue to review the draft proposal that was submitted.
on the last round so that they will be able to meet'the timelines we"will need on the nex t
round to make a definitive decision within the PDUFA goal date . 1 7
Since Barr submitted its full dual-marketing proposal in July 2004, this timefrarne would
have required OCC to complete its review three to four months later, by October or November
2004 ." However, a conclusive review apparently did not occur . Despite receiving the dual-
marketing proposal in March 2004, despite the analysis performed by CDER's policy office, and
despite the expiration of the PDUFA deadlines, FDA states that it has still not resolved the . .
relevant regulatory questions .
The Federal Records Act
When GAO's report was released in November of 2005, I wrote to Secretary Leavitt
along with a number of my colleagues . 19 In addition to requesting more information about the
Plan B decision, we asked why FDA staff had told GAO that, in apparent violation of-the. Federal
Records Act, emails from the Office of the Commissioner were deleted daily and backup files
were only retained for 16 days .
In your response of January 27, 2006, you wrote, "In this case there is no evidence that
there was any deviation from both customary practice and compliance with the law . Any
speculation to the contrary has no basis in fact"20 Respectfully, our concern was not speculative .
A July 2005 email from the Office of the Commissioner to GAO states explicitly that"'
"[Commissioner and Deputy Commissioner for Operations] Drs .'Crawfora ind wood6ock delete
their emails on a daily basis and the emails are held in backup for 16 days ."21 Even if, as the
1
7 Email from John K . Jenkins, Director, Office of New Drugs, to Steven Galson et al .
(May 14, 2004) . The P rescri ption Drug User Fee Act sets performance ' goals for the completion
of FDA reviews of various types of applications .
18 a r Laboratories, Barr Submits Response to FDA in Support of Over-the-Counter
B r
Status for Plan B(R) Emergency Contraceptive (Jul . 22 ; 2004) (online at
http ://www .barrlabs.com) .
19 Letter from Rep . Henry Waxman et al. to Secretary Michael Leavitt (Nov. 14, 2005)
(online at http ://www .derxiocrats .reform.house .gov/Docum.ents/20051117133 505=58156 .pdf).
2
0 Letter from Dr . Andrew C . von Eschenbach to Rep . Henry A_ Waxman (Jan. 27, 2006) .
2
1 Email from Office of the Commissioner, FDA, to GAO (Jul '7, 2dd~ .
.av . aWaua 11 1
qJ UU2S
11

March 9, 2006
Page 7
agency later claimed, backup files were retained for 16 weeks, the practice would not approach
the standards required by the Federal Records Act nor FDA's document retention policy .21̀
Conclusio n
FDA has justified its indefinite delay of the plan B decision by citing the "diff cult and
novel" issues raised by the scientifically unsupported age restrictions that, it urged be added to
the amended application. But the internal agency documents I have obtained reveal tlzat the
supposedly "novel" regulatory questions raised by the application had been under consideration
by the agency for over a year . It appears that the Office of Chief Counsel simply failed, despite
repeated requests, to produce a dispositive analysis .
I request an explanation of the agency's actions in the case of Plan B, including all
documents from CDER's regulatory analysis and an account'of why the Office of Chief Counsel
apparently failed to respond to repeated requests for a timely legal analysis of Barr's amended
application . If the lawyers did in fact prepare an analysis, please explain why FDA announced in
August 2005 that it was unable to resolve the key regulatory questions by that time . In addition,
please address the apparent violation of the Federal Records Act .
I ask that you respond to this letter by March 27, 2006 .
Sincerely,
uk, C`
Henry A . Waxman
Ranking Minority Member
22 Under the Federal Records Act, no records of the federal government may be
"alien ated or destroyed" except under the regulations promulgated by the Archivist and the
schedules submit tied by the agencies . 44 USC 3314; 36 C.F.R. I228,100.+ Electrom c messages
such as emails have been held to be "records" under the Federal Records Act and must be
retained even, if printed copies exist . Armstrong v Executive. Office
_ :,of the President,
., ..t.~~,.~,_ .:.,..f..... . Office of
Admin . (1993, App DC) 303 US App DC 107,_ I F3d 127~{ s pohcy statement on email
information notes that emails that qualify as records `~nust be retained" and that "[bjackups of e-
mail files . . . are not to serve any archival purpose and should not be used as _a record s
• snanagement tool ." The FDA statement also notes that ev en "routine administrative
correspondence" must be retained for two years. Food and Drug Adrrunistration, Policy
Statementfor Management of Email fnfortnation, from PW Automated Information Systems
Security Policies and Procedures Manual.
...v . a.aaa- uaai . .. . .
t s
FAX COVE R
COMMITTEE ON GOVERNMENT REFOR M
DEMOCRATIC STAFF OFFrCE
HON. HENRY A. WAX1UrA N

RANKING MINORITY MEM 8 E W- `~ -' :-
B350A RAYBURN HOUSE WILDING
PHONE (202) 225-505 1
FAX (202) 225-4784, 818 5
DATE : March 9, 200 6
TO : The Honorable Andrew C . Von Eschenbach . M.D.
FAX: (301) 443-310 0
FROM : Rep, Henry A. Waxman
SUBJECT :
NO . OF PAGES : 8
(tNCLUDING COVER-SHEE~' l
COMMENT :
IF THERE IS A PROBLEM w(TH TH1S

TRANSMITTAL, PLEASB'CkLL'O`FFI-ag`Y`A~S :AP '
DEPARTMENT OF HEALTH & HUMAN SERVICE S

Rockville MD 2085 7
The Honorable Henry A . Waxman

Ranking Minority Member
Committee on Government Reform
House of Representatives JUN 7 2006
W ashington, D .C . 20515-614 3
Dear Mr. Waxman :
Thank you for your letter of March 9, 2006, regarding the United States Food and Drug
Administration's (FDA or the Agency) oversight of an application to change Plan B, an
emergency contraceptive drug product, from prescription-only to over-the-counter (OTC)
status . In your letter, you refer to the drug sponsor's (Barr Research, Inc .) situation as a
"regulatory 'Catch 22"' created by the Agency, and you state that there were delays by variou s
offices within FDA . We respectfully suggest that your characterizations of the Agency's
actions are not accurate .
. .~ . _: . ., . . .
During the Agency's review of the data in the initial supplemental new drug , application
(sNDA) for the prescription to OTC change for Plan B, FDA~ deteimined that the data were
insufficient to meet the statutory and regulatory requirements for such a change for the
youngest population of women . FDA informally discussed this issue with the sponsor and
the sponsor submitted an amendment to their sNDA on March 11, 2004 . This amendment
proposed a dual marketing strategy, seeking to make Plan B OTC for women 16 years of age
and older and prescription-only for women under age 16 .
On May 6, 2004, Dr . Steven Galson, then the Acting Director (now the Director) of FDA's
Center for Drug Evaluation and Research (CDER) issued a letter to the sponsor, stating that
the sNDA was "not approvable at this time under section 505(d) of the Food, Drug, and
Cosmetic (FD&C) Act and Title 21, Code ofFederal Regulations (CFR) §314.125(b)" (see
....
letter from Steven Galson, M .D ., M .P .H ., Acting Director, CDER, to Joseph A . Ca:rrado,
M .Sc., Ph .D ., Senior Director, Regulatory Affairs, Barr Research, Inc ., at page 1, available at
http ://www.fda.gov/cder/drug/infopage/planB/planB NALetter .pdf(emphasis added)) .
Dr. Galson concluded that the sponsor had "not provided adequate data to support a
conclusion that Plan B can be safely used by young adolescent women for emergency
contraception without the professional supervision of a practrtioner licensed by- .law to
administer the drug" (Id.) . Among other things, Dr. Galson noted that only 29 of the 585
subjects enrolled .in Barr's actual use study were between the ages of 14 and 16, and none
were under the age of 14 (Id.) .
Page 2- The Honorable Henry A . Waxman
.
Regarding the March 11, 2004, amendment to the sNDA described above, Dr . Galson 'stated~"
in his May 6, 2004, letter to the sponsor that "[t)his preliminary proposal
. did not include draft
product labeling to demonstrate how you propose to comply with both the prescription and
non-prescription labeling requirements in a single packaging configuration . Because of the
preliminary and incomplete nature of the proposal, we did not conduct a complete review of
this amendment during this review cycle . "
In the May 6, 2004, letter, Dr . Galson advised the sponsor that, before their sNDA for Plan B
could be approved, they would have to either: (1) submit data demonstratingthat the product
could be used safely by women under 16 years of age without professional supervision by "a
licensed practitioner,t or (2) provide further information in support of their alternate proposal
to allow marketing as a prescription-only product for women under 16 years of age and as an
OTC product for women age 16 years and older. Dr. Galson further explained that if the
sponsor chose the latter approach the sponsor would need to submit details of how it proposed
to :
" . . .implement simultaneous prescription and non-prescription marketing of Plan B

for women of different ages in a single packaging configuration while complying with
all relevant statutory and regulatory requirements for labeling and marketing of this
product . We will have to assure ourselves that your proposed approach is consistent
with our statutory authority . If you pursue the alternative approach, we also would
request details of your proposed program to educate consumers, pharmacists, and
physicians about the dual marketing of Plan Bfas both a prescnption and non-
prescription product, as well as your proposed program to monitor implementation of
this novel approach . "
On July 22, 2004, the sponsor chose the second approach an d filed an amended sNDA,
proposing to market Plan B as a non-prescription product for women age 16 an d older an d as
a prescri ption-only product for women under age 16 . Over the coming months, several
offi ces within both CDER and the Office of the Commissioner, including the Office of the
Chief Counsel (OCC), were engaged in consideration of the legal, regulatory , scienti fic, and
policy issues raised by the novel approach proposed in the sNDA .
After much discussion an d deliberation, then Commissioner Lester M. Crawford

. : determined
,
that it would be useful and desirable to obtain public comment on some of these iss
_ .ues. On
August 26, 2005, the Agency announced that it was issuing an Advanced Notice of Proposed
Rulemaking (ANPRM), which was published in the Federal Register (FR)-on September 1,
2005, (see 70 FR 52050 ( Sept . 1, 2005)). The Ah7PRlVi requested public comment on the
following issues :
1.
A . Should FDA initiate a rulemaking to codify its interpretation of
section 503(b) of the FD&C Act regarding when an active ingredient can b e
' The data in the sNDA were stratified by age in the following
_ . categories :. 12-16 years, 17-25 years, and 26
years and older . Dr . Galson later clarified that the data were insufficient to establish that women 16 years of age
and younger can use Plan B safely as an OTC product.
simultaneously marketed in both aprescription drug product and an OTC drug

product?
B . Is there significant confusion regarding FDA's interpretation o f

section 503(b) of the FD&C Act ?
C . If so, would a rulemaking on this issue help dispel that

confusion ?
2.
A . If FDA limited sale of an OTC product to a particular
subpopulation, e.g., by making the product available to the., subpopulation
_ . by
- _
prescription only, would FDA be able to enforce such 'a_ limitation as a matter
of law?
B . If it could, would it be able to do so as a practical matter and, if

so, how ?
,3 .
A . Assuming it is legal to market the same active ingredient in both
a prescription and OTC product, may the different products be legally sold in
the same package ?
B . If the two products may be lawfully sold in a single package,

under what circumstances would it be inappropriate to do so!' '
70 Fed . Reg . 52050, 52051 (Sept . 1, 2005). FDA requested public comment on the ANPRM
by November 1, 2005 . The Agency received approximately 47,000 comments on the
ANPRM and is continuing to review those comments .
Also, on August 26, 2005, Dr .. Crawford wrote to the sponsor in response to its amended
sNDA with respect to Plan B . In the letter, FDA advised the sponsor that CDER "has
completed its review of this application, as amended, and has concluded that the availabl e
scientific data are sufficient to support the safe use of Plan B as an OTC product, but only for
women who are 17 years of age and older . However, the Agency is unable at this time to
reach a decision on the approvability of the application tiecause of unresolved issues that
relate to the sNDA for Plan B (see Letter from Lester IVI:`Crawford, D .
Commissioner of Food and D.ru gs, to Joseph A . Carrado,. M -, _ .Sc ., Ph.D . ; Senior Director,
Regulatory Affaius, Duramed Research Inc ., hereinafter."Crawford Letter to Duramed"), at
page 1 available at http ://www;fda.gov/cder/drug/infopage/planB/Plan B Ietter20051
The letter identi fi ed "three difficult and novel issues" presented by the Plan 13 sNDA •
whether the identical drug product can be simultaneously marketed as a prescription-only
product and an OTC-product based on the age of . the individual using the
. drug (as opposed to
,prescriptona dOTCmarketingbasedondifernti dcations, trengths,do s - age forms, or
routes of administration of the drug) ; how, as a practical matter, such an age-based limitation
could be enforced ; and whether prescription-only and OTC versions ofthe'same active
ingredient can be marketed in the same packaging . fifie letter advised t~e sponsor that at
this time, the drug product may not be legally marketed OTC :` In the future, you will b e
noti fi ed in w ri ting regarding changes in the status of your application . Underl21 _CFR-
§314 .102(d), you may request an informal meeting or telephone conference to discuss what
steps need to be taken before the application may be approved" (see Crawford Letter to
Duramed at page 2 (emphasis added) . The sponsor has'- not requested such a meeting or
conference . Since August 2005, we have not issued a final decision ori the sponsor's sNDA .
As you can see from above, the Agency recognized early in the regulatory review process that
a dual marketing approach raised novel and difficult issues and communicated those concerns
to the sponsor. The sponsor, nevertheless, opted to pursue this approach . Regarding the role
of FDA's OCC, as is the case with legal matters that arise during the review , of any produc t
application submission, OCC provides legal advice to the vanous components of the Agency .
In this case, OCC participated in the review and consideration of the legal questions raised by
the sponsor's application . OCC has provided legal counsel throughout the review process.
The internal FDA e-mail and attached "brief summary" -- labeled "DRAFT" -- that you
received was drafted by a staff member in_ CDER'S- Office of Regulatory Policy and.._contain s
_ _ . . . . . _ . . . . ,..
the preliminary opinions of that Office regarding FDA's authority to approve Barr's "dual
marketing" proposal on Plan B . Moreover, the draft summary, which purports to describe
whether FDA has the legal authority to approve the same active ingredient as prescription and
OTC at the same time and for such a product to be"marketed in the same_package, was not
written by anyone in OCC, the office responsible for providing legal advice to'FDA on issues
under the FD&C Act .
,. .
Thank you for your continued interest in this issue . If we can be of further assistance, please
let us know .
Sincerely,
vid W . Boyer
Assistant Commissioner
for Legislation

CREW: Food and Drug Administration - Plan B: OL4

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Oct-07-05 ' 08 :57am From-5laushte r 202-225-7822 T-642 P .

Andrew von Eschenbach, M .D.

Dear Acting Commissioner von Eschenbach:

First and foremost, we are very disappointed with then-Conumu5sioner Crawford'srYatiaotmcement a a

PRINTED ON P9C7p.E0 PhAER;

1 . Louise M . Slaughter, Member of Congress 32. Luis V . Gutierrez, , Member, of Congress

FROM THE WASHIIKGTOIN OFFICE OF

Pi.EasEDmim To: ai r . AAzL;t' SaC.11 cLi/

Washington office fax number, (202)'22S-7822

Food and Drug Administration

The Honorable Judy Biggert

cc : Docket Management Branch - HFA-305

Food and Drug Administration

The Honorable Joseph Crowley

Dear Mr. Crowley :

Page 2 - The Honorable Joseph Crowle y

without the professional supervision of a licensed practitioner, and 2) an amended proposal

Food and Drug Administration

The Honorable Carolyn B . Maloney

without the professional supervision of a licensed practitioner, and 2) an amended proposal

Dr . Lester Crawford, Commissioner

PRINTED ON RECYC LED PAPER

The Honorable Joseph I . Lieberman

The Honorable Diana DeGette

Page 2 - The Honorable Diana DeGett e

without the professional supervision of a licensed practitioner, and 2) an amended proposal

Page 3 - The Honorable Diana DeGette

'United ol3tates eStnate ~ o0 FOREIGN RELATION S

June 12, 200 6

Mr. Amit Sachde v

Mr . Mintz is concerned about over-the-counter approval of "Plan B" emergency

Category : Social Religious

Dear Senator Martinez,

InterTrac Tracksheet 01 1 06 1 12/2006

Food and Drug Administration

cc : The Honorable Mel Martinez

"United ~$ tates $enate FOREIGN RELATIONS

April 26, 200 6

Ms .doconcerned about availability of Plan B over the counter . I am enclosing her

RSHINGTON, DC 20510 -0906

Category : Social Religious

Web Mail Subject : FDA

Please give me information when Plan B will be given final approval . It

InterTrac Tracksheet 01 1 04/26/2006

DEPARTMENT OF HEALTH -& HUMAN SERVICES

cc : The Honorable Mel Martinez

-anifeb .W af:e.W .-%-excU#C,

March 27, 200 6

With best wishes,

Anchorage Fairbanks Juneau Wasilla Kenai SetcLikan .,. _ . ._. __ _ _ Bethel

<IP>209 .112 .152 .119</IP>

The Honorable Ted Stevens

Dear Senator Stevens :

e letter of March 27, 2006, on behalf of your constituent, Ms .

Co nqrea of the Vnixeb bt a te q

Honorable Andrew C . von Eschenbach, M .D .

Dear Dr . von Eschenbach:

Honorable Andrew C . von Eschenbach, M .D .

In March 2004, Barr submitted an amendment to its application, proposing a dual-

1 Government Accountability Office, Food and Drug Administration : Decision Process

Honorable Andrew C . von Eschenbach, M .D .

6 Letter from Steven Galson, supra note 3 .

Honorable Andrew C . von Eschenbach, M.D .

A statement by then-FDA Commissioner Lester Crawford expressed similar views :