The Food and Drug Administration was in the news again, this time for the proliferation of counterfeit products being sold online. It is the agency tasked to vet and approve food, medicine, medical devices, and even cosmetics, household substances, toys and child care articles and the establishments selling these products.

In a hearing of the Senate Committee on Health and Demography, FDA Director General Paolo Teston was taken to task and asked to resign by Senator Raffy Tulfo for delayed approvals and the continuing sale of unregistered and counterfeit products online.

Admittedly, the FDA has a very broad mandate and has limited number of personnel to process hundreds of thousands of pre-market applications annually, with fewer than 250 evaluators. Post-market enforcement only has 248 field personnel and a 28-member regulatory enforcement unit. It is also hampered by the limitation of imposing fines only on violators with no provision for imprisonment. Senator Risa Hontiveros is moving to amend existing laws that will impose prison terms for violators.

It is time for the FDA to limit its focus on food and drugs/medical devices that is the main reasonfor its existence. The proposed amendment should also remove the regulation of cosmetics, child care articles and the sale of these products from its tasks to enable the FDA to concentrate on its core mission: safe and effective medicines and devices. Other agencies should take over vetting other products to enable more effective regulation.

Maybe partly due to its broad mandate, the FDA has likewise failed to act on approval of many medical products including vaccines. If the recent news that counterfeit dengue vaccines are being peddled is true, then the public is getting shortchanged when they buy these counterfeits and risk their safety with unsafe and ineffective products. It is because we don’t have an approved dengue vaccine up to now.

Meanwhile, the application for approval of a dengue vaccine, TAK-003, is languishing in pre-approval purgatory. It has been three years since it’s developer, Takeda Pharmaceuticals, submitted its application to the FDA. In April 2025, the FDA asked questions about the product which Takeda has replied to within a month. Yet, we still have to see approval of a product that we obviously need desperately due to the grave toll dengue is taking among Filipinos. Meanwhile, it is now used in many countries with great efficacy.

Not only is the delay in approval giving rise to a black market of fake dengue vaccines, it also highlights the fact that despite years of the 4S/5S advice the DOH is still pursuing, we are bound to miss the WHO push for a global goal of zero dengue deaths by 2030, a scant four years from now.

Granted that the fallout from the Dengvaxia controversy is still ongoing, the issue of vaccine hesitancy has been fanned and inflamed again. It may also be the main reason for the inaction of the FDA in approving the vaccine, wanting to avoid being dragged into litigation like some previous FDA officials.

But aren’t they supposed to make such decisions for the greater good of the citizenry? If the FDA has been delinquent in its job of policing the market for counterfeit drugs and vaccines, it is also delinquent in approving a well-studied and vetted vaccine that has seen real world use for the past three years across the globe.

Its leadership should see the great harm on dengue victims, who are mainly children, and the many deaths due to dengue, by dragging their feet over vaccine approval. Otherwise, they should just resign and let others with more courage take over.

In case the FDA missed the studies the company has provided it, there is real world evidence of the safety and efficacy profile of TAK-003. With millions of doses given worldwide, and no deaths attributable to the vaccine reported, there is no safety signal to be wary of. It doesn’t matter if the potential vaccinee never had dengue before, and there is no need to test for prior exposure.

Vaccine efficacy is notably high. It provides protection against all four serotypes, generating both humoral (antibodies) and cell-mediated immunity. It is effective against dengue-related hospitalization and symptomatic dengue disease up to 4.5 years post-vaccination with two doses.

The FDA should seriously consider approving the dengue vaccine now. Let us end the annual outbreaks of dengue with hundreds of deaths and thousands of hospitalizations that drive families further into poverty due to medical expenses. It isn’t too late to aspire for zero dengue deaths by 2030. You just need the courage to sign that approval and millions of Filipino families will thank you for it.