CREW: Food and Drug Administration - Plan B: OL5

' MEL MARTINEZ COMMITTEES:
FLORIDA AGING
(202) 224-3041 BANKING
ENERGY AND NATURAL RESOURCES
FOREIGN RELATIONS_ "
February 14, 200 6
Mr . Amit Sachdev
Associate Commissioner for Legislation
Food And Drug Administration
Parklawn Buildin g
5600 Fishers Lane, Room 1547
Rockville, Maryland 2085 7
Dear Mr . Sachdev : i
~~ (00
I am contacting you on behalf of my constituent, M
concerned about the FDA's rejection of an application to make Plan B

emergency contraception available over-the-counter . I am enclosing her correspondence for you r
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 Senator
MM/jcg
Enclosure
C)Oo b - / 6 10
~
MEL MARTINEZ COMMfnEES:
FLORIDA
AGING
1202)224-3041 BANKING
ENERGY AND NATURAL RESOURCE S
'United 115tates $enat e FOREIGN RELATION S
W Gl°oN, oc"zo5,~6~spondence Tracking Shee t
Category : Abortion
Campaign / Group : Morning After Pill
Assigned To : Jenn Gallagher
Status :_ Ope
: WebnRecivdVa
Date Received : 11/15/2005
Web Mail Subject : Report on FDA`"rnorning after "pil l
Once again the neocons of your party have twisted the truth on the
scientific evidence of the "morning after pill" .
How many more lies are going to be told to the American people for political
purposes ?
Incase your party has not noticed, we are sick of these lies and will not stand
for the religous right to take over our country .
Please look at what fundamentlist have done to the "middle east", their __ .
backward thinking and lack of progressive measutes to grow for the good of
their countrmen has been their demise . If you continue to let these small
percentages of people lie and change policies for their unpopular agendas, you
will soon be out of a job .
Please look into this and stop the lies please .
Notes/Comments :
Route History :
02/14/2006 - 07:08 PM - Jenn Gallagher - Printed Tracksheet . .
11/15/200511 :12:49 AM - Created manually by Victor Ceriiino via lnterTrac WebMail .
InterTrac Tracksheet 01 1 02/14/2006

DEPARTMENT OF HEALTH, & HUMAN SERVICES,
Food and Drug Administration

Rockville MD 20857
APR 11 200 6
Dear M
Thank you for your letter of February 14, 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 respond
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 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 .
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 NDA
(b) (6)
Page 2
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 non-prescription
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/planB NALetter .pd, f)
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 the 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 lett er to the Duramed Research, Inc ., ( copy enclosed and available
at : http:/hvww.fda .gov/cder/drug/infopage/p1anB/Plan_B_letter20050826 .pdJ)
stating that FDA had completed its review of the application and that the scienti fi c data
supported the safe and effective use of Plan B a- an OTC product for women ages 17and 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 applica ti on .
In the le tt er to the sponsor, FDA identified three difficult and novel issues presented by the
application, issues for which the Agency is commi tted 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 we re asked to respond to conce rn 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 presc ription only or
OTC, depending on the age of the purchaser . A related concern is how, as a practical ma tter, an
age-based distinction could be enforced .
(b) (6)
Page 2 -
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,
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 contacting Senator Ma rt inez conce rn ing this matter .
Sincerely,
. A . l
rG 1 \ . I
David W . Boyer
Assistant Commissioner
for Legislatio n
4 Enclosures
(b) (6)
cc : The Honorable Mel Martinez .,.

States Senate .United
Washington, D .C. 20510-0906
r MEL MARTINEZ COMMITTEES:
FLORIDA AGING
(202)224-3041 BANKING
ENERGY AND NATURAL RESOURCES, .
United 15tates .16enete FOREIGN RELATION S
WASHINGTON, DC 2051U=0906
December 12, 200 5
Mr . Amit Sachde v
Associate Commissioner for Legislation
Food And Drug Administration
-
Parklawn Building
5600 Fishers Lane, Room 1 547
Rockville, Maryland 2085 7
Dear Mr . Sachdev:
I am contacting you on behalf of my constituent,
Ms . ' A~h - ~oncerned about over ..,.

the . ... _~counter
. counte sales of emergency contraceptives . I
. Please ramenclosighrpndecfoyurviw address. your response to her directly .
Thank you for your attention to this matter . Please do not hesitate
,._ :. to
.. . .contact
..~ ~_ .. ._.me with any
r: .,r=.~=_u :. .
questions or comments .
Sincerely ,
Mel Martine z
United States Senator
MM/jcg
Enclosure- .. . .
ao0 f- /3 6
Sep 21 05 12 :51p J . F . Bubinak 9413668185 p . 1
September 21, 200 5
Dear Senator Martinez,

__ __ IV
I of the FDAAlearndth has iridefinitely postponed a decision on whether to le t
the morning after pill be sold without a prescription . He has done this against the advice of his
own scientists and in contradiction to his previous statements . I though the FDA was meant to
be guided by facts in it's role of protecting the health of America . I urge you to protest and
investigate this blatantly political and unscientific action ,
Sincerely,
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September 2, 200 5
Dr . Lester Crawford
Commissioner
U .S . Food and Drug Administration
56 00 Fishers Lan e
Rockville, MD 2085 7
Dear Dr. Crawford :

I write today regarding the pending application before the Food and Drug Administration
(FDA) to make Plan 13 available over,the-counter on an age-restricted basis . Your
announcement of August 26, that the FDA was u n able to reach a decision on the
pending application, and would instead initiate an open=ended notice-and-comment
rulemaking, was surprising to me .
As you know, Health and Human Services Secretary Michael 0 . Leavitt sent me a letter
on July 13, 2005, indicating that "the FDA will act on this application by September 1,
2005 .°
Although I have concerns about wider availability of Plan B, I am deeply disappointed

that your announcement did not comport with the agreed-upon deadline for a decision .
Regarding the rylemaking, I agree that there are complex legal and regulatory questions
raised by this application . However, I note that the application was deemed complete
by your agency on July 21, 2004 ,
It is not clear to me why it took over a year to decide that answering these legal and
regulatory questions merited a ryleRtaking, Many of these questions were apparent the
day the application was 'deemed complete . In addition, I believe you were aware of
these questions because you testified to their novelty and complexity during your
confirmation hearing before my committee on March 17 of this year .
Given the nature of the questions involved, and the requirements of the Administrative
Procedures Act, this rulemaking could take months, if not years .
O~ °0 S ' 5_7 3(~

SEP . 2 .2005 2=00PM N0 .041 P . 3/3
Page Two
Dr. Lester Crawford
you have indicated that expediting this rulemaking will be a personal priority of yours,
In order to assess your attention to this issue, I request that you answer the following
questions by September 16, 2005 .
1 . What are the next steps in your rulemaking process on this issue? Do you intend to
publish an interim final rule and then issue a final rule? Or do you intend to move
from the proposed rule directly to a final rule ?
2 . How long of a comment period do you intend to offer during each step of the
rulemaking process ?
3 . Are there any steps that must be taken other than conclusion of the ruiemaking
process before the FDA is able to reach a final decision on the pending Pian B
application ?
4 . How long after conclusion of the rulemaking process will it take for FDA to issue a
final decision on the pending Plan B application ?
1(ook forward to receiving your responses to these important ques tions .
Sincerely ,
Michael B, EnA
Chairma n
cc: Secretary Michael O . Leavitt

DEPARTMENT OF HEALTH & HUMAN SERVICES

Rockville MD 20857
The Honorable Mike Enzi OCT. 3 1200 5

Chairman
Committee on Health, Education, Labor and Pensions
United States Senat e
Washington, D .C . 20510-830 0
Dear Mr. Chairman:
Thank you for your letter of September 2, 2005, and the opportunity to update you on the Food
and Drug Administration's (FDA) response to the pending application to make Plan B available
over-the-counter .
First, I w an t to emphasize that it is the FDA's policy to move as quickly as possible on all
pending drug applications .
As you know, on May 6, 2004, the FDA issued a Not Approvable action letter in response to an
application for a switch from prescription (Rx) only status to over the counter (OTC) status for
Plan B Tablets . In response, the sponsor submitted a revised application .
The revised supplemental new drug application proposes a switch from Rx only status to OTC
status for women ages sixteen years and older . Under the revised supplemental new drug
application, Plan B would remain Rx only for women under sixteen years of age . In addition, the
sponsor proposed that both the Rx and OTC version of Plan B be marketed with the same .
labeling and packaging.
Although the Center for Drug Evaluation and Research (CDER) has completed its review of this
application, the FDA was unable to reach a decision on the approvability of the application
because of unresolved issues that relate to the supplemental new drug application discussed
below.
This application has presented FDA with three difficult and novel issues . While FDA has _
allowed the same active ingredient to be marketed both Rx and OTC based on differences in
indication, strength, dosage form and route of administration, the Agency has never determined
whether a drug with the same indication, strength, dosage form and route of administration may
be both Rx and OTC based solely on the age of the individual using the dru g . A related concern
is how, as a practical matter, an age-based distinction could be enforced . In addition, FDA has
never been confronted with whether the Rx and OTC versions of a :drug with the same active
ingredient may be marketed with the same labeling and packaging .
Chairman Enzi
Page 2
Questions have arisen over the years about whether there are any conditions under which an
active ingredient may be simultaneously marketed in both a prescription drug product and an
OTC drug product . However, the FDA's interpretation of section 503(b) of the Act has not
been explicitly set forth in any of the regulations that discuss the process by which FDA
classifies (or re-classifies) drugs as OTC or prescription . See 21 CFR 310.200 and -310 .201 .
Accordingly, the Agency decided that the appropriate course was to ask for public comments
on whether we should initiate a rulemaking to codify our interpretation of section 503(b)
regarding when an active ingredient can be simultaneously marketed in both a prescription
drug product and an OTC drug product . To this end, FDA has published an advance notice of
proposed rulemaking in the Federal Register . In addition, the notice seeks public comments
on questions related to the marketing of Rx and OTC versions of the same active ingredient
with the same labeling and packaging .
In your letter, you raised a concern regarding the time that it took to determine that these
questions merited seeking public input . As you noted, Dr. Crawford referenced the novelty
and complexity of the questions raised by the application when testifying before you on
March 17 of this year. Upon receipt of an application, the center works to address both the
scientific and regulatory aspects of an application, and it is important that this work be done
simultaneously. It is often not possible to have a complete understanding of the possible
regulatory issues of an application until the scientific aspects have been vetted and
understood . Accordingly, it is often not possible to determine whether an application contains
novel regulatory questions and, if so, whether those merit seeking public comment until they
have been considered alongside a scientific review . The Agency experienced this to be the
case as it related to this supplemental new drug application.
You asked several specific questions, which I have addressed below .
1 . What are the next steps in your rulemaking process on this issue? Do you intend
to publish an interim final rule and then issue a final rule? Or do you intend to
move from the proposed rule directly to a final rule ?
On September 1, 2005, FDA published in the Federal Register an Advanced Notice of

a Proposed Rulemaking (ANPRM) in which it solicited public feedback on questions
related to section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U .S .C .
353(b)) .
An ANPRM is not a proposed rule . This is a mechanism to ask for public comments
on whether we should initiate a rulemaking to codify our interpretation of section
503(b) regarding when an active ingredient can be simultaneously marketed in both a
prescription drug product and an OTC drug product for the same indication, strength,
dosage form and route of administration .
Chairman Enzi
Page 3
The comment period will end on November 1, 2005 - at which point we will
expeditiously review and respond to the comments we . have received and determine
the appropriate next steps . 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 .
2 . How long of a comment period do you intend to offer during each step of the
rulemaking process?
The ANPRM provides the public with 60 days to file comment and is scheduled to
close on November 1, 2005 . Typically, the Agency solicits public comment for a
minimum of 90 days when initiating this type of process . Although it is the Agency's
intention to move quickly, we cannot project whether we will follow a rulemaking
process or the . potential timing until we review the comments received in response to
the ANPRM .
3 . Are there any steps that must be taken other than the conclusion of the __
rulemaking p rocess before the FDA is able to reach a final decision on the _
pending Plan B application ?
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in

Barr Laboratories' application . For example, as set forth in the letter (enclosed) that
FDA sent to the sponsor 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, Barr may need to
amend its supplemental application . Please note, however, that, as FDA's August 26
letter to Barr describes, CDER has completed its scientific review of Barr's pending
supplemental application .
4 . How long after the conclusion of the rulemaking process will it take for FDA to
issue a final decision on the pending plan B app lication ?
It is the Agency's intention to move through an expedited process and come to a final
decision on this application very shortly thereafter . Although it is the Agency's
intention to move quickly, we cannot project the potential timing until we have the
opportunity to review the comments received in response to the ANPRM.
Chairman Enzi
Page 4
I appreciate your interest in bringing this process to a timely conclusion, and the Agency will
work as quickly as possible to complete this application . Please let me know if you have
additional questions or how I may be of further assistance :
Andrev}/ C. ' von Eschenbach, M.D .

Acting! Commissioner of Food and Drugs
Enclosure
.ARTIvffiN"f OF HEALTFf iSc HUMAN SER"C: Pubfic , Heatth Se~ e
Foad ~a_ndp"tit g :Adminis_tration
RQCkyi(!e, NO 208,5-17 -
g;ilst'I&, 200
N-,D A 21-645/s-b3 f
DurameilResearch, In .
~#te,nt~q~i Joseph A Canrado, 'M . ~c R.Ph:
Senior bifectar, Re Dilatory Af~àirs
.One-Belmont Ave .i 1* floo r
Bala Cynwyd, PA 190 E 4t
,ear Mr . Carcado:
Please iefer to yeizlr ~plernental new drug appl~cation . dated April 16 2a ', rece~ved Apn122 2003 .>
_~
submitted under seetiqn`505~j ofthe Federai Food, ISiu;, and" Casmetio Act -the ~rct~ for. ._,P1an
. .B
(Ievoriorgestrel) Tab7ets; 4 .7~ rug I
We acknowledge receipt of your subniissions dated April 16, July 25 (3), ai zd 3 I gast 8 (2);
Segem4eir 4, 8, 9, and I5,. (3ctabeF 6, 10 ; 15`(Z . 17, 21, 24)-79' 3'0 a 6"ii'31, I?"ece,diber 3, anc~ 91,201,_
January 9F. an d 30, February b, 10, I3 ; ~:0, and 24;11ii'arch 11 adIo,`KIay 6 and 11, Ju~ie 30, July 21 ,
24d4, And January 6, 12; 13, 14, 18, T9 and 21, 20 0 5 .
Yaur ~bmission of 7uly 2'1, ~Oa4 constftuted a compieterespo iise to our 6, 2404ISTdz Api rovabl'e
acifian IOer .
T1ie;resAmitted supplemebta .l new drug application provides far a. sw3tcli~ro~ only sratns to+Ovei
the t6unter (OTC) statu,s for women ages sixteen years and older Plan B renYazn Rx,only fo r
war~n under sixteen years of age lnàddition, you havepropose that 'lo e .Ptand OTC version .
o0tan 'B be marketed in a =g 1e package .
T1te;Center for Drug Evaluation and Research (CDBR) has coiiipleted its review of this 4ppltcation, as
amended, and has concluded that the available scientific data are sti~`zcient #o'suppvrt the safe use of
Plan B as .iin CTC piroduct, but only for women wiio are 1,7 Y. ofag an~ o~~er. However; th e`
AgeitGy is unable at this ti me to reach a decision on the apprc~"Uabiltty of theapplication
., l~e~se o f
. <_
unresolved issues'that relate to your DA discussed below'
"Ya~ir application has presenf.ect us with three diff ciilt and no vel i ies- Specifically, you have
propo.sed that ,Plan B be mark' ted in a single package, and sold either as Rx ox ©TG, depe~ dtng on the
age•-offihe.patienf:. Whi1e tlre Agency has allowed the same .active rdgtedlen> to be marketed both Rx
and !'C Eiased on iadieation, strength, dosage form and route of adm fnistsation, the 1~genej~ hais never
determined whether a clriig May be bdtfi ~e and OTC based on the age of the indivic~ual using the dtug :`
AreIated concern :is .hovsr., as"a practical mat#er an age-based d'istin ttiaa coul~~be eitforced; In
additiori, ve have neverbeen confronted ,W4h vvhethe" the Rx and 0T~ versions afthe same active
i4gheclient maybe, marketed uia single package . ~..~,. ..
41
I~A 2~-d451S-~1I
Page Z
As you rbay be arcrare, quesUons have anse~ii over the years abat~t w iether ttiere are,any c~aadmqns
u~nder ~hic.}x an apfiive ingredient may be simultaneously marketed i i~both a. preseziptron drag prod
and'an OTC cft-Lig product otM, lt~anding -our'havii~g a1lo~ve4 ~ practice in those rare instances
~heFe tbefe ~s a~a 'W ~ di~erence'tn t#te u~dication; str °eugt~, dc ~e~for"r~z or route u~ '
a€~on e tv :o pioduc~; vve recogpize that FDA's inton p ~ sec fiiSn 503(b) o£ihe~
as:hot een tlg set forthni ay of the regulatxons ,thA discuss M -t~e J process by whic~ FIDA; - ::
ies,{or ~r~~l~~es) gs as O TC or pr~Cript3c~n gee 2-I 2,0,0., 3 1G`
'k' , ^~i~x "~ i~ ".'` ~ - --k-•~~,~ ~-c~ 3~ •y~r~ » ,~ r. .7.~
In This aase, we~ave decided fi~iat the apgrogziate couse is to as~ for puco; amerits ag wbet~er~ve~
should initiate a iulenifiatang~~
to'e ottr interpretation
4o~it'y `sect~o S03 ,of
n r(b)
areg ~ ~ act~e`
when
ingredient caxz be simuttaneously, inazketedii~. both a grescripti~in dnig"gro~uct and an OTC d~ug
product. 'I`6 #his end, vsre have decided to publish : an advance notice of propo$ed ru lem alCirfg'm the
Federal Register In a~d~tic~ the i~atice will seek public co mm ents on q~estions reTated to t~se
market~ng oUx and OTC versions of th e same active ingredient in a singte'package.
At'tf~s ti~e, t hie drug product may not be legally marketed flTC . In the
-: fiitare,
w . . you wi11 be nntrfied in
writinb.r aard'
~ 'a c~es in tlid stalia~ af your application.
_`- :- ; ' ~. , -z:::.•Y ~. ;_ .; ,: ~;
bndez 21 CFR 3 T4 142(d), you may request an uifortnal meeting ar teTephone conffereffice ta disc ss
wliat steps-teed to b e ta~cen'hefore tbe application maybe approved;
irieerely,
este.z rawp6rd', iwN

àmmis~iorier of Food an

Rockville MD 2085 7
The Honorable Jane Harman

House of Representatives
W as hington, D . C . 20515=053 6 MAY 1 1 200 6
Dear Ms . Harman :
Thank you for the lett er of January 19, 2005, co-signed by fifty-one of your colleagues, in
which you express your views 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 presc ription only to over-the-counter (OTC) . We would like to take this
opportunity to clarify below the current status of the Agency's activities concerning this
application.
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 .
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
advisory in nature and are not binding on the Agency . Since the final determination
.__ :.. on an y
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
from advisory committee members and the opportunity to hear an exchange of ideas on
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
Page 2 - The Honorable Jane Harma n
.cycle to change the requested indication to allow for marketing of Pl an B as a presc ription
only product for women under 16 years of age and a nonpresc ri ption product for women 16
years an d 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 expl anation 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/p1anB 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 decision was b as ed 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 superv ision of a licensed practitioner. Therefore, the
data in the application did not suppo rt 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 make
Pl an 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 Pl an B in a single package,
an d sold either as prescri ption 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 .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 final decision on
the approvability of the application due to unresolved issues that related to the application .
In the letter to the sponsor, FDA identified three difficult 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 . section 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.
questions that FDA was asked to answer, and the proposal that was put forward by the
Page 3 - The Honorable Jane Harman
sponsor, presented the Agency with many very difficult and novel policy and regulatory
questions . In some c as es, the questions requiring an FDA response were unp re cedented 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 comriients 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, asset forth in the letter FDA sent to Duramed Research,
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 the re will be no confusion
about the public statements FDA actually has made concerning the Barr/Duramed Pla n
B/OTC application, in addition to the two lett ers 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 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,
D Wi d W. Boyer
for Legislatio n
4 Enclosures
~'NS[lVlflt .~
DEPARTMENT OF HEALTH & HUMAN SERVICE S
°'+nla
Rockville MD 20857
The Honorable James P . Moran

Washington, D . C . 20515-460 8 MAY 1 1 200 5
Dear Mr . Moran :
Thank you for the letter of January 1 9, 2005, co-signed by fifty-one of your colleagues, in
Plan B, from prescription only to over-the-counter (OTC) . We would like to take this
application .
determine a proposed new product's safety and effectiveness for, the uses put forth by the
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
question(s) before the committee . The busy schedules of the committee members require that
Page 2 - The Honorable James P . Moran
cycle to ch ange the requested indication to allow for marketing of Pl an 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
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/planB_NALetter .pdf.
That decision by the Acting Director of CDER was made after MI. review of all the
underlying data and an alysis and after discussions with all of the approp ri ate Agency
personnel. This decision was b ased on his assessment that the data in the supplemental
contraception without the professional supe rv ision of a licensed practitioner. Therefore, the
data in the application did not support approval of the supplement . In its Not Approvable
approval to market Plan B as an OTC drug . The issuance of a Not Approvable le tter did not
me an that a supplemental application could not or would not be approved in the future.
Pl an B an OTC product for women age 16 and over, an d to have it remain prescription only
for women under age 16 . The company also sought to market Pl an B in a single package,
and sold either as prescri ption only or OTC, depending on the age of the purchaser .
available at : http ://www.fda .gov/cder/drug/infopage/planB/Plan_B letter20050826.pdf)
United States Code , section 353(b)) . The questions the interested parties were asked to
purchaser. A related concern is how, as a practical matter, an age-based distinction could be
enforced .
questions that 1?bA was asked to answer, and the proposal that was put forward by the
Page 3 - The Honorable James P . Moran
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 .
days when initiating this type of process, in the .interest of moving quickly on this issue, the
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
The Agency has found that considerable misinformation hascirculated 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
Agency issued concerning this application.
Sincerely ,
id W . Boyer I-'
for Legislatio n
4 Enclosures

Rockville MD 20857
The Honorable Chris Van Hollen

Washington, D . C . 20515-2008 M AY 1 1 200 6
Dear Mr . Van Hollen :
Thank you for the letter of January 19, 2005, co-signed by fifty-one of your colleagues, in
application.
Page 2 - The Honorable Chris Van Holle n
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
wwwfda. go v/cder/drug/infopage/planB_NALetter . pdf.
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
could understand the label and use the product safely and effectively-for emergency
contraception without the professional supervision of a licensed practitioner . Therefore, the
approval to market Plan B as an . OTC drug. The issuance of a Not Approvable letter did not
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 .
available at: http ://www.fda .gov/cder/drug/infopage/planB/Plan-B-letter20050826 .pd.f)
over. FDA also stated, however, that it was unable at that time to reach a final decision on
United States Code, section 353(b)) . The questions the interested parties were asked to
enforced.
Page 3 - The Honorable Chris Van Holle n
this Agency .
Inc., on August 26, 2005, while the application sought approval for the switch for ages 16 and
Please note, however, that as FDA's August 261etter to Duramed describes, CDER has
and the reasons FDA has taken the actions it has to this point . So there will be no confusion
B/OTC application, in addition to the two letters to the spon'sor mentioned above, we are
Thank you again for your interest in this ma tter . If we can be of further assistance, please let
Sincerely,
A&id W . Boyer
for Legislatio n
4 Enclosures

Rockville MD 2085 7
The Honorable Tammy Baldwin

House of Representatives MAY 1 1 2006
Washington, D . C . 20515-4902
Dear Ms . Baldwin :
application .
Page 2 - The Honorable Tammy Baldwi n
cycle to change the requested indication to allow for marketing of Plan B as a prescription .
conveyed to the sponsor by the then-Acting Director of FDA's Center for Drug Evaluatio n
www.fda .gov/cder/drug/infopage/p1anB_NALetter.pdf.
personnel . This decision was based on his assessment that the data in the,s u.pplemental
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., ap . proved in the future .
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%p1anB/Plan B_Ietter20050826.pdf)
suppo rted the safe and effective use of Plan B as an OTC product for women ages 17 and
In the letter to the sponsor, FDA identified . three difficult and novel issues presented by the
process was initiated with the publication on September 1, 2005, of an Advance Notice o f
enforced .
Page 3 - The Honorable Tammy Baldwi n
sponsor,, presented the Agency with many very difficult and novel policy and regulatory
this Agency.
initiate a rulemaking to codify our interpretation of section 503(b) of the FD&C
, .. Act regardin ,. g
when an active ingredient can simultaneously be marketed in both a prescrtp.~h ondrug prod .uct
administration . Although the Agency typically solicits public comment for a minimum of 9 0
comment period was shortened to 60 days for this ANPRM . The public comment period o n
packaging and the use of age as a criterion on which to base a distinction between OTC an d
prescription use . Accordingly, Duramed may need to amend its supplemental application.
Please note, however, that as FDA's August 26 letter to Duramed desc ribes, CDER has
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 BarrlDuramed Pla n
B/OTC application, in addition to the two letters to the sponsor mentioned above, we are
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,
id W . Boye r
for Legislatio n
4 Enclosures
o►*~ uKn%

Rockville MD 20 857
The Honorable Christopher Shays

House of Representatives MAY 1 1 200 6
Washington, D . C . 20515-070 4
Dear Mr . Shays :
application .
Page 2 - The Honorable Christopher Shays
www. fda . go v/cder/drug/infopage/p1 a nB_NALetter. pdf.
personnel . . This decision was based on his assessment that the data in the supplemental
could understand the .label and use the product safely and effectively for emergency
and sold either as presc ri ption only or OTC, depending on the age of the purchaser :
available at : http : //www.fda.gov/cder/drug/infopage/planB/Plan Bletter20050826 .pdf )
stating that FDA had completed its review of the application and that the scienti fic data
enforced .
Page 3 - The Honorable Christopher Shays
this Agency.
packaging and the use of age as a criterion on which to base a .distinction between OTC, and
Sincerely,
D" W . Boyer '

for Legislatio n
4 Enclosures
'aStLA itls
.`
so`~ '~
« / DEPARTMENT OF HEALTH & HUMAN SERVICES
= J~
Rockville MD 20857
The Honorable Henry A . Waxman

House of Representatives .
MAY 1 1 200 6
Washington, D. C . 20515-0530
Dear Mr . Waxman :
application.
data presented supports the proposed uses stated by the manufacturer in the proposed labeling-
Your lett er referenced the 23-4 vote taken at the joint advisory commi ttee meeting in
December 2003, recommending that Plan B be sold OTC. Advisory committee opinions are
advisory in nature an d are not binding on the Agency . Since the final determination on any
questions that may remain after the close of an adviso ry commi ttee meeting or that were
question(s) before the commi ttee . The busy schedules of the committee members require that
advisory committee meetings be scheduled well in advance . We cert ainly value the input
from advisory commi ttee members and the opportunity to hear an exchange of ideas on
proposed new products from expert s in their respective scientific fields . It should not be
presumed, however, that a favorable vote by an adviso ry committee automatically means that
were not provided to suppo rt a conclusion that young adolescent women can safely and
licensed practitioner, and 2) an amended proposal submi tted by the sponsor du ring the review
Page 2 - The Honorable Henry A . Waxman
only product for women under 16 years of age and 'a nonprescription product for women 1 6
conveyed to the sponsor by the then-Acting Director of FDA's Center-for Drug Evaluatio n
and Research (CDER) with a full explanation of the reasons behind FDA's decision in a No t
Approvable letter dated May 6, 2004, (copy enclosed) and available online at.
www.fda.gov/cder/drug/infopage/planB NALetter.pdf.
application did not contain sufficient information about whether younger adolescent wome n
.
data in the application did not suppo rt approval of the supplement . In its Not Approvable
le tt er 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 le tter did not
Plan B an OTC product for women age 16 and over, and to have it remain presc ription only
and sold either as presc ription 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_letter200S0826 .pdf)
respond to concern when an active ingredient of a drug may be simultaneousIy marketed as
enforced.
As the Agency has said many times du ri ng the course of the review of this application, th e
Page 3 - The Honorable Henry A . Waxma n
sponsor, presented the Agency with many very difficult and novel policy and regulato ry
this Agency.
An ANPRM is a mechan ism to ask for public comments on whether the Agency shoul d
initiate a rulemaking to codify our interpretation of section 503(b) .of the FD&C Act regarding
when an active ingredient c an simultaneously be marketed in both a prescription drug produc t
and an OTC drug product for the same indication, strength, dosage form and route o f
administration . Although the Agency typically solicits'public_co .,mment for a minimum of 90
these comments, we are committed to moving forward as quickly as possible :
prescription use. Accordingly, Duramed may need to amend its supplemental application .
about the public statements FDA actually has made concerning the Barr/DuramedPla n
B/OTC application, in addition to the two letters to the sponsor mentioned above, we are-'
Sincerely,
id W . Boyer
for Legislation
4 Enclosures

Rockville MD 20857
The Honorable Danny K . Davi s

I-louse of Representatives M AY 1 1 2006
Washington, D . C . 20515-130 7
Dear Mr . Davis :
Agency) processing of the supplemental new drug application from Barr Laboratories (no w
Plan B, from prescription only to over-the-counter (OTC) . We would like to'take this
application .
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
A product cannot be approved until FDA determines that the product "is safe and effective'for
the indications stated in the proposed labeling.
identified during the meeting, even though a vote may have been taken-'on-the main
Page 2 - The Honorable Danny K . Davi s
years and older was incomplete and inadequate for a full review . This message wa s
and Research (CDER) with a full explanation of the reasons behind FDA's decision ina No t
Approvable letter dated May 6, 2004, (copy enclosed) and available online at:
www.fda .gov/cder/drug/infopage/planB_NALetter .pdf.
letter to the sponsor, FDA outlined some additional information that would tie required fo r
available at : http : //www.fda.gov/cder/drug/infopagelplanB/Plan_B_Ietter20050826 .pdf)
over. FDA also stated, however, that it was unable at that time to . reach a final decision on
application, issues for which the Agency is committed toa process for'resolving . That
enforced .
questions that FDA was asked to answer, and tl•ie proposal that was put forward by th e
r
Page 3 - The Honorable Danny K. Davis
questions . In some c ases, the questions requi ring an FDA response were unprecedented for
this Agency .
comment period was shortened to 60 days for this ANPRM. The public comment period on
letters it received . While we cannot put an exact timeline on how long it will take to proces s
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in th e

older, CDER found that the data supported only for ages 17 and older . Moreover, th e
Please note, however, that as FDA's August 26 letter .to Duramed describes, CDER has
Thank you again for your interest in this matter. If we can be of further assistance, please let
Sincerely,
cl W . Boyer
for Legislation
4 Enclosures
Y
~J~~N SiaYlt(J .4T' .
Y ^f ~ DEPARTMENT OF HEALTH & . HUMAN SERVICES .
w >a Food and Drug Administration

Rockville MD 2085 7
The Honorable Juanita Millender-McDonald

House of Representative s
Washington, D . C . 20515-053 7
MAY 1 1 2006
Dear Ms . Millender-McDonald :
application.
the indications stated in the proposed labeling.
In May of 2004, FDA completed its first review of the NDA to switch Plan_ .B to OTC, and
were not provided to suppo rt a conclusion that young adolescent women can safely an d
Page 2 - The Honorable Juanita Millender-McDonald ,
www.fda.gov/cder/drug/infopage/p1anB_NALetter .pdf.
could understand the label, and_use the product safely and effectively for emergency
Plan B an OTC product for women age 16 and over, an d to have it remain presc ription only
In August 2005, FDA wrote a le tter to the Duramed Research, Inc ., ( copy enclosed and
available at : http ://ivww.fda.gov/cder/drug/infopage/planB/Plan_B Ietter20050826 .pdf)
suppo rted the safe and effective use of Plan B as anOTC product for women ages 17 an d
over. FDA also stated, however, that it w as 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 letter to the sponsor, FDA identified three difficult and novel . issues presented by the
both a prescription and'as an OTC drug product, whether and how OTC availability of a
product could be sold either as prescription only or OTC, depending on the age of th e
purchaser. A related conce rn is how, as a practical matter, an age-based distinction could be
enforced.
questions that FDA was asked to answer, and the proposal that was put forward .by the
Page 3 - The Honorable Juanita Millender-McDonal d
sponsor, presented the Agency with many very difficult and novel policy and regulator y
this Agency.
administration . Although the Agency typically solicits public comment for a minimum .of 90.
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 an d
packaging and the use of age as a criterion on which to base a distinction between OTCan d
Please note, however, that as FDA's August 261etter to Duramed describes, CDER has
The Agency has found that considerable misinformation has .circulated about this application
B/OTC application, in addition to the two letters, to the sponsor mentioned above, we are
Thank you again for your interest in this ma tter. If we can be of fu rther assistance, ple as e let
us know. A similar response is being sent to each of the other co-signers of your le tter.
Sincerely ,
DaV'id W . Boyer
for Legislation
4 Enclosures

Rockville MD 2085 7
The Honorable Timothy H . Bishop

MAY 1 1 2006
Washington, D . C . 20515-320 1
Dear Mr. Bishop :
which you express your views about the Food and Drug Administration's (FDA or th e
application.
Your le tter referenced the 23-4 vote taken at the joint adviso ry commi ttee meeting in
adviso ry 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 cla rify any unanswered
questions that may remain after the close of an adviso ry committee meeting or that were
question(s) before the commi ttee . The busy schedules of the committ ee members require that
adviso ry commi tt ee meetings be scheduled well in advance . We certainly value the input
from advisory commi ttee members and the opportunity to hear an exchange of ideas on
presumed, however, that a favorable vote by an adviso ry commi ttee automatically means that
licensed practitioner, and''l) an amended proposal submitted by the sponsor during the review
Page 2 - The Honorable Timothy H. Bishop '
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 nonprescription product f6r 'women 16
years and older w as incomplete and inadequate for , a full _review Thi- s message was
and Research (CDER) with a full explanation of the re asons behind FDA's decision in a Not
_ .. ,
Approvable letter dated May 6, 2004, (copy enclosed ) and available on~e at
wrvw. fda. gov/cder/drug/infopage/p1anB_NALetter . pdf.
underlying data and analysis and after-di scussions with all of the app'ropriateAgency
personnel. This decision was based on his assessment that the data in thesuppl .emental
contraception without the professional supervision of a licensed practit'io'ner . Therefore, the
data in the application did not support approval of the supplement . In itsNot Approvable
letter to the sponsor, FDA outlined some additional information that would be required fo r
approval to market Plan B as an OTC drug : _The issuance of a Not Approvable. letter did not
Plan B an OTC product for women age 16 and over, and to have it remain prescription onl y
In August 2005, FDA wrote a le tter to the Duramed Research, Inc., ( copy enclosed and
available at: http://www.fda.gov/cder/drug/infopage/p1anB/Plan_B letter20450826 .pdf)
stating that FDA had completed its review oft he application and -that ,the scientifi c , data
suppo rted 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 fi nal decision on
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, Drng, "and Cosmetic (FD&C) Act (Title 21,
product could be sold either as prescription only or OTC, depending on the age of th e
enforced .
questiorts that FDA was asked to answer, and the proposal that was put forward by the
Page 3 - The Honorable Timothy H . Bishop
this Agency .
when an active . ingredient can simultaneously be marketed in both a prescription drug product
days when initiating this type of process, in the interest of moving quickly on this issue',-th e-
Inc ., on August 26, 2005, while the application sought approval for the switch for ages 16 an d
older, CDER found that the data supported only for ages 17 and older. Moreover, the
packaging and the use of age as a criterion on which to base a distinction between OTC an d
and the reasons FDA has taken the actions it has to this-point . So there will be no confusion
B/OTC. application, in addition to the two letters to the sponsor mentioned above, we ar e
enclosing copies of the two press releases dated May 7, 2004, and August 26, 2005, that th e
Agency issued conce rning this application .
Sincerely,
Difid W . Boyer
for Legislatio n
4 Enclosures
i
. .. . . . . .. . . . . ~
J+~NSeavflcrr.~~ .
// DEPARTMENT OF HEALTH St HUMAN SERVICES„

~. J4 . _ ..< . . .,_ _ . _ : ,_ .
+~tivaia
Rockville MD 20857
The Honorable Russ Carnahan

W as hington, D . C. 2051 5 MAY 1 1 200 6
Dear Mr . Carnahan :
owned by Duramed Research, Inc .) that proposes to change the niarketing status of the dnig,
application .
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 suppo rt a conclusion that young adolescent women c an safely and
licensed practitioner, an d 2) an amended proposal submitted by the sponsor du ri ng the review
Page 2 - The Honorable Russ Carnahan
and Research (CDER) with, a full explanation of the reasons behind FDA's decision in a,Not .
www.fda.gov/cder/drug/infopage/p1anB_NALetter :pdf.
That decision by the Acting Director of CDER was made after full review of all the .
letter to the sponsor, FDA outlined some additional information that would be -required for
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- IetterZ0050826.pdf)
stating that FDA had completed its review of the application and that the scientific dat a
In the letter to the sponsor, FDA identified three difficult and. novel issues presented by the
related to section 503(b) of the Federal Food,-Drug ; and Cosmetic (FD&C) Act (Title 21,
enforced .
questions that FDA was asked to answer, and the -proposal that was put forward by the
Page 3 - The Honorable Russ Carnaha n
this Agency.
An ANPRM is a mechanism to ask for public comments on whether the-Agency should

administration. Although the Agency typically solicits public comment for, a minimum of 90
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, th e
outcome of FDA's rulemaking process may impact the approvability
. ,_ the
of hproposed
The Agency has found that considerable misinformation has . circulated about this application
us know. A similar response is being sent to each of the other co-signers of your letter .
Sincerely,
id W . Boyer
for Legislation
4 Enclosures
J~, stxnct,s .~4
~~ ~ DEPARTMENT OF HEALTH & HUMAN SERVICES

~
~
Rockville MD 2085 7
The Honorable James P . McGovern

Washington, D . C . 20515-2103 MAY 1 1 200 6
Dear Mr . McGovern :
application .
Page 2 - The Honorable James P . McGover n
cycle to change the requested indicati on to allow for marketing of Pl an B as a prescription

only product for women under 16 years of age an d a nonprescription product for women 16
years an d older was incomplete and inadequate for a full review . This message was
an d Research (CDER) with a full expl an ation of the reasons behind FDA's decision in a Not
www.fda .gov/cder/drug/infopage/p1anB NALetter .pdf.
could understand the label and use the product safely and effectively for emergency :
contraception without the professional supervision of a licensed practitioner. Therefore, the
available at : http ://www.fda.gov/cder/drug/infopage/p1anB/Plan_B_letter20050826.pdf)
both a prescription and as an OTC drug product, whether and how OTC availabilityof a
enforced.
Page 3 - The Honorable James P . McGovern
this Agency.
when an active ingredient can simultaneously be marketed in both a prescri ption drug product
and an OTC drug product for the same indication, strength, dosage form and route of-
these comments, we are committed to . moving forward as quickly as possible .
sponsor's application . For example, asset forth in the letter FDA sent to Duramed Research,
and the reasons FDA has taken the actions it has to this point . So therewifl be no confiision
us know . A similar re sponse is being sent to each of the other co-signers of your letter.
Sincerely,
id W. Boyer
for Legislatio n
4 Enclosures

Rockville MD 2085 7
The Honorable John F . Tierney

House of Representative s
Washington, D . C . 20515-2 1 06 MAY 1 1 200 6
Dear Mr . Tierney :
which you express your views about the Food and Drug Administration's (FDA or th e
Agency) processing of the supplemental new dru g application from Barr Laboratories (now
owned by Duramed Research, Inc .) that proposes to change the marketing status of the _drug ,
Plan B, from prescri ption only to over-the-counter (OTC) . We would like to take thi s
opportunity to clarify below the current status of the Agency's activities concern ing this
application .
advisory in nature and are not binding on the Agency . Since the final determination
_ on any
In May of 2004, FDA completed its first review of the NDA to switch Plan B to OTC, an d
were not provided to suppo rt a conclusion that young adolescent women can safely and
effectively use Pl an B for emergency contraception without the professional supe rvision of a
licensed practitioner, an d 2) an amended proposal submitted by the sponsor during the review
i
Page 2 - The Honorable John F . Tierney
www.fda .gov/cder/drug/infopage/p1anB_NALetter .pdf.
That decision by the Acting Director of CDER was made after full-review of all the
personnel . This decision was based on his assessment that the . data in the supplemental
contraception without the professional supervision of a licensed practitioner. Therefore, the
available at : http ://www.fda .gov/cder/drug/infopage/planB/Plan_B_letter20050826 .pdJ)
enforced .
As the Agency has said many times duri ng the course of the review of this application, the
questions that FDA was asked to answer, and the proposal that w as put forward by the
Page 3 - The Honorable John F . Tierney
this Agency.
Sincerely,
>✓~~W . Boyer "

Assistant Commissione r
for Legislatio n
4 Enclosures

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' MEL MARTINEZ COMMITTEES:

February 14, 200 6

concerned about the FDA's rejection of an application to make Plan B

'United 115tates $enat e FOREIGN RELATION S

W Gl°oN, oc"zo5,~6~spondence Tracking Shee t

Web Mail Subject : Report on FDA`"rnorning after "pil l

Please look into this and stop the lies please .

InterTrac Tracksheet 01 1 02/14/2006

Food and Drug Administration

cc : The Honorable Mel Martinez .,.

United 15tates .16enete FOREIGN RELATION S

December 12, 200 5

I am contacting you on behalf of my constituent,

Ms . ' A~h - ~oncerned about over ..,.

September 21, 200 5

Dear Senator Martinez,

~n~t a ~nm . wropnna . qY~NN~N

4" Put"". NOW kip

Dear Dr. Crawford :

Although I have concerns about wider availability of Plan B, I am deeply disappointed

O~ °0 S ' 5_7 3(~

1(ook forward to receiving your responses to these important ques tions .

cc: Secretary Michael O . Leavitt

Food and Drug Administration

The Honorable Mike Enzi OCT. 3 1200 5

Dear Mr. Chairman:

You asked several specific questions, which I have addressed below .

On September 1, 2005, FDA published in the Federal Register an Advanced Notice of

Notwithstanding the outcome of the rulemaking process, there remain deficiencies in

Andrev}/ C. ' von Eschenbach, M.D .

este.z rawp6rd', iwN

Food and Drug Administration

The Honorable Jane Harman

DEPARTMENT OF HEALTH & HUMAN SERVICE S

The Honorable James P . Moran

cycle to ch ange the requested indication to allow for marketing of Pl an B as a prescription

Food and Drug Administration

The Honorable Chris Van Hollen

Dear Mr . Van Hollen :

Food and Drug Administration

The Honorable Tammy Baldwin

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

The Honorable Christopher Shays

D" W . Boyer '

The Honorable Henry A . Waxman

Food and Drug Administration

The Honorable Danny K . Davi s

Notwithstanding the outcome of the rulemaking process, there remain deficiencies in th e

Y ^f ~ DEPARTMENT OF HEALTH & . HUMAN SERVICES .

w >a Food and Drug Administration

The Honorable Juanita Millender-McDonald

Food and Drug Administration

The Honorable Timothy H . Bishop

Dear Mr. Bishop :

// DEPARTMENT OF HEALTH St HUMAN SERVICES„

The Honorable Russ Carnahan

An ANPRM is a mechanism to ask for public comments on whether the-Agency should

~~ ~ DEPARTMENT OF HEALTH & HUMAN SERVICES

The Honorable James P . McGovern

cycle to change the requested indicati on to allow for marketing of Pl an B as a prescription

Food and Drug Administration

The Honorable John F . Tierney

Page 2 - The Honorable John F . Tierney