Maria April Trish Albaña PH 4B

A ‘new’ FDA

The Food and Drugs Administration (FDA) is marking its 54th anniversary this coming week. This
government agency, attached under the Department of Health (DOH), is more than half-a-century old.
But it has taken on a “youthful” look as far as the services it renders to the public are concerned. To be
young means to be bold and fast. That may be the way the present FDA is being viewed and which
accounts for its image as being young despite being all of 54 years old.

The much-improved public image of the FDA may have also been bolstered by the proverbial young
blood now at the helm of the agency. It is headed by new director-general, pharmacy board topnotcher
Nela Charade Puno. The reforms she quickly put in place after President Rodrigo Duterte named her to
the post are clear reflections of that fact – she is bold and prefers to get things done fast.

Puno hit the ground running, so to speak, with bold initiatives that previous FDA heads may have opted
not to take.

First, she intensified the agency’s law enforcement campaign against counterfeit and fake cosmetics,
drugs and similar other products. Then, she imposed a faster, simpler process of approving applications
for product registration with the FDA. Third, she stood up against powerful international business
interests who had gotten used to bullying the executives who manned the FDA.

The FDA immediately earned kudos when Puno immediately inked a deal with the Philippine National
Police (PNP) for joint operations against manufacturers and peddlers of unregistered and counterfeit
products.

FDA specifically targeted syndicates and merchandisers selling fake, counterfeit or unregistered drugs,
food products, cosmetics and other concoctions to an unsuspecting public. Puno aired a warning against
them. Thinking the warning was just for media mileage – just a charade of the FDA chief to poke fun at
her name – they were caught red-handed when the agency actually conducted law enforcement
operations against them.
These moves earned the public’s trust to the FDA as the protector of consumers. It was a major
departure from the usual excuse by past FDA executives about the agency not having enough budget to
conduct law enforcement activities as part of its legal mandate.

Such initiatives show the FDA protects public interests and shields ordinary Filipino consumers from the
danger of imitation and outright fake beauty and health products.

The FDA head also wowed the public when she simplified the product registration process. This was a
decisive reform and removed the cause of the backlog that had accumulated over years of turtle-paced
action, or total inaction on the part of some bureaucrats in the agency.

It appears the FDA has also computerized much of the product registration process. This makes it easier
for entrepreneurs to register their products and track the progress – or lack of it – because they can now
check it online.

Puno’s feat has done a lot for these entrepreneurs. They can now get their products into the market and
make a profit faster. Naturally, it has also spared them from the cost of having to “grease” some
unscrupulous bureaucrats who man and run the registration process.

That faster registration process should take away any reason for these entrepreneurs to sell unregistered
products. This means the streamlining and computerization process will directly benefit ultimately the
general public, and not just product developers and merchandisers.

In yet another feat, the FDA ordered earlier the pharmaceutical giant Sanofi Pasteur, Inc. to stop airing
expensive commercials on television and radio about its anti-dengue vaccine, Dengvaxia. Sanofi, at that
time, was the object of a snowballing clamor for a Senate investigation. This had to do with the giant
pharma firm’s having sold to the previous administration some P3.5 billion worth of anti-dengue
vaccines. The clamor had to do with fears that the vaccine may have allegedly caused death of one or
two public school pupils to whom it was administered.

In an unprecedented move, the FDA further ordered Sanofi to take down its radio and television
commercials promoting the very same anti-dengue vaccine in question. The FDA chief warned such
airing of the ads was a violation of Philippine laws prohibiting the advertisement of so-called ethical or
prescription drugs.

In this confrontation, Sanofi blinked. The global pharmaceutical giant chose to immediately comply with
the order of FDA.

These have been the developments that have brought in a whiff of fresh air at the FDA. We hope to see
more in the years to come.

These developments manifest how the FDA has a direct relevance to the daily lives of ordinary Filipinos.

Coinciding with its 54th anniversary, the agency will be holding its 1st regulatory and advocacy fair on
Aug. 17-18 at the PICC.

The Fair will reportedly feature booths displaying the profile of stakeholders in the food, drug, cosmetics
and medical devices industries. The Regulatory Fair aims to promote awareness on FDA mandates and
the roles of its stakeholders and government partner agencies in the protection of public health by
ensuring the safety of food, drugs, cosmetics and medical devices being used by the Filipino public.

The FDA stakeholder industry associations announced they will also showcase their advocacy activities
and best practices, benefits of compliance to FDA rules and regulations, benefits of joining professional
organizations in regulatory affairs, success stories in regulations, quality management programs among
others.

Currently, the FDA chief disclosed they have started processing the certification and re-certification for
contraceptive products considered legal, non-abortifacient and effective by next week. The Supreme
Court earlier directed the DOH and FDA to formulate guidelines, procedures in the screening, evaluation,
approval, purchase and distribution of all contraceptive drugs that will be used under the Responsible
Parenthood and Reproductive Health Law, taking into account the need to observe due process such as
notice and hearing.
Puno promised that by September 30 to first week of October, the FDA may issue the certificate of
product registrations “to be able to re-certify the first batch of contraceptives.”

Warning Against Dispensing Expired Drugs

The Bureau of Food and Drugs has monitored several cases of dispensing expired drugs. There seemed
to be a misguided notion that a drug is still effective for an allowable number of days/months beyond its
expiration date.

Contrary to this belief, there is no guarantee given that the drug will provide its purported safely, efficacy
or good quality after such drug has expired.

Expiry date is defined in A.O. # 55 s. 1988. "Requirement for the Labeling of Pharmaceutical Products", as
the date after which the product is not expected to retain its claimed safety, efficacy and quality or
potency, or after which il is not permissible to sell, distribute or use said product.

Anent to this, Section 8(1) of Executive Order No. 175. amending Section II of R,A. 3720. "The Foods,
Drugs. Device,," and Cosmetics Act", prohibits the sale or offering for sale of any drug or device beyond
ils expiration date. Such prohibited act is punishable by imprisonment of not less than one year but not
more than five years or a fine of not less than five thousand pesos but not more than ten thousand
pesos or both.

In view thereof, in the interest of the general public and for the safety of patients, the Bureau of Food
and Drugs hereby warns all pharmacists in the practice of pharmacy including medical practitioners
against dispensing/distributing expired drugs either commercially or for free.

Declaring and Adopting the Philippine Pharmacopeia as the Official Book of Standards and Reference for
Pharmaceutical Products and Crude Plant Drugs in the Philippines
WHEREAS, it is State Policy under Article II, Section 15 of the 1987 Constitution to "protect and promote
the right to health of the people and instill health consciousness among them";

WHEREAS, the 1987 Constitution also provides in Article XIII, Section 12, that: "The State shall establish
and maintain an effective food and drug regulatory system and undertake appropriate health manpower
development and research, responsive to the country’s health needs and problems";

WHEREAS, a national pharmacopeia that adequately establishes standards for drug/drug products and
crude drugs available for commerce in the Philippines is essential to the attainment of an effective
regulatory and health care delivery systems and addresses the foregoing constitutional mandates;

NOW, THEREFORE, I GLORIA MACAPAGAL-ARROYO, President of the Philippines, do hereby order:

SECTION 1. The Philippine Pharmacopea (PP) 1st edition April 2004 and any supplement thereto, is
hereby declared and adopted as the official book of the standards and references for the determination
of the identity, purity, and quality of pharmaceutical products and crude plant drugs in the Philippines.

SECTION 2. For pharmaceutical products and crude plant drugs that are not listed in the PP, reference
maybe made to the latest editions of United States Pharmacopeia/National Formulary (USP/NF),
Japanese Pharmacopeia (JP), British Pharmacopeia (BP) European Pharmacopeia (EP), and International
Pharmacopeia (IP) and other books of standards and references as maybe recognized and adopted by
the Bureau of Food and Drugs from time to time.

SECTION 3. All orders, issuances, rules and regulations, or parts thereof inconsistent with this Executive
Order are hereby repealed or modified accordingly.

SECTION 4. This Executive Order shall take effect fifteen (15) days after publication in the Official Gazette.
Done in the City Manila this 29th day of March, in the year of Our Lord, two thousand and four.

(Sgd.) GLORIA MACAPAGAL-ARROYO

By the President:

(Sgd.) ALBERTO G. ROMULO

Executive Secretary