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FDA Chief Faces Senate Scrutiny Over Online Drug Risks

Manila: The chief of the Food and Drug Administration (FDA) came under Senate scrutiny Tuesday as he defended ongoing reforms while lawmakers raised concerns over delayed approvals and the continued sale of counterfeit and unregulated health products, particularly online. FDA Director General Paolo Teston told the Senate Committee on Health and Demography that he serves at the discretion of the President and is prepared to relinquish the post should a more qualified official be appointed.

According to Philippines News Agency, this statement from Teston followed Senator Raffy Tulfo's repeated calls for his resignation. Teston emphasized his willingness to step down if a more capable leader is found, stating, "I serve at the pleasure of the people acting for the President. If there is someone better than me to head the agency, I'll gladly yield the post to that better person." He mentioned that he had submitted his courtesy resignation in June 2025 in compliance with Malaca±ang's directive to agency heads. Since taking office in May 2025, Teston has expanded the FDA's human resources and is finalizing the agency's five-year development plan for submission to the committee.

Committee chairperson, Senator Risa Hontiveros, convened the hearing in response to the growing risks posed by counterfeit and unregulated health products, especially those sold online. She introduced Senate Bill 564, the Counterfeit Pharmaceutical Products Prevention Act, to protect Filipino consumers purchasing health products online. Hontiveros warned that counterfeit products might contain no active ingredients or be ineffective, while unregulated products pose dangers as they bypass proper FDA evaluation and clinical trials.

Senator Tulfo highlighted the FDA's role in the inquiry, criticizing Teston for enforcement failures and regulatory lapses. He noted illegal sales of prescription-only medicines online without prescriptions, which promote self-medication and antibiotic resistance. Tulfo also raised concerns about fake advertisements, AI-manipulated endorsements, and the online sale of unregistered weight-loss drugs, describing these as "shortcuts to danger."

Data presented during the hearing revealed that the FDA processes approximately 254,000 pre-market applications annually with fewer than 250 evaluators. Post-market enforcement relies on 248 field personnel and a 28-member regulatory enforcement unit. In the past eight months, authorities seized PHP56.89 million worth of violative and counterfeit health products, with 1,531 online listings taken down since November last year.

Senator Risa Hontiveros is considering amendments to existing laws after the FDA disclosed that courts have imposed fines, not jail time, on sellers of unregistered and counterfeit health products. This issue was raised after FDA officials informed the committee that while cases have been filed under Republic Act 3720 and 9711, penalties have been limited to fines, allowing violators to avoid imprisonment. Hontiveros questioned whether this area could be amended, suggesting stronger provisions, including declaring certain large-scale counterfeiting activities as economic sabotage.

FDA Deputy Director General Franklin Tabaquin acknowledged that while some cases have led to convictions, court-imposed penalties have been limited to fines. He expressed support for stronger legal provisions to address the issue.