Villafuerte bats for stronger FDA vs counterfeit medicines

(Pexels)

Camarines Sur 2nd district Rep. LRay Villafuerte is calling on his colleagues in the House of Representatives to help strengthen the Food and Drug Administration (FDA) amid the recent surge in counterfeit over-the-counter (OTC) medicines.

Under his House Bill (HB) No. 3984, Villafuerte is seeking the establishment of a pharmacovigilance unit within the FDA’s Center for Drug Regulation and Research (CDRR).

The said unit aims to crack down on manufacturers and dealers of counterfeit or substandard drugs for common ailments like fever, colds or coughs that are even sold online.

“Being an archipelago, the Philippines is vulnerable to the illegal entry of smuggled goods including medicines. Cases of counterfeit pharmaceutical products entering and moving through countries worldwide are increasing with the growing sale of such contraband via the Internet,” Villafuerte said in a statement.

“The FDA must step its game on pharmacovigilance as the proliferation of bogus medicines are becoming more complex and compounded,” he stressed.

With the intent of fortifying the country’s system of pharmacovigilance——or the detection and assessment of the efficacy of medicine——the measure likewise mandates the FDA to develop a consumer advocacy and education program.

According to the lawmaker, this program would educate consumers on the dangers of using bogus or substandard pharmaceutical items.

In an earlier advisory, FDA Director-General Samuel Zacate said his office had found counterfeit versions of OTC medicines Kremil S, Alaxan FR, Biogesic, Medicol Advance, Bioflu, and Tuseran Forte in the local market.

The FDA, in a follow-up warning in August, said that on top of these OTC drugs, it has also found other counterfeit medicines locally, including Solmux and Diatabs capsules.

The agency has warned the public that these counterfeit medicines “pose potential danger or injury to consumers".

It has likewise told all drug outlets not sell these products, since the sale of such are in violation of Republic Act (RA) No. 9711, or the FDA Act of 2009, and RA No. 8203, or the Special Law on Counterfeit Drugs of 1996.

HB No. 3984 specifically defines counterfeit medicines as “those that either have no active ingredients, have active ingredients but not the correct amounts as claimed, or have wrong ingredients—thereby affecting the safety, efficacy, quality, strength and/or purity of these types of drugs”.

Products that are deliberately and fraudulently misrepresented with respect to their respective identities, compositions and/or sources are also classified as counterfeit drugs under the bill.

When the amount of the counterfeit products involved is P1 million or higher, as valued by the DFA, the offense would be considered “economic sabotage”.

This act would merit the penalties of life imprisonment and a fine ranging from P5 million to P10 million.