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.”

We join the public in wishing the FDA all the best as it marks its anniversary this week.