Inamag na application: FDA hit over delays in approving generic drugs

By Billy Begas

House Deputy Speaker Bernadette Herrera on Monday expressed concern on the “unnecessary delay” in the approval of first-time generic medicines for chronic diseases such as diabetes and hypertension.

Herrera said the delayed action of the Food and Drug Administration (FDA) is depriving people access to affordable life-saving drugs.

She revealed that at least seven applications for first-time generics, which were filed as early as December 2019, have been “gathering dust” at the FDA.

“Why is the FDA taking so long to approve these generic drugs when it knows for a fact that the timely availability of these medicines would increase affordability for many Filipinos?” Herrera asked.

First-time generics are the very first generic versions of branded medicines to be approved by the FDA.

The generic version is formulated to work in the same way as the brand-name product and provides the same clinical benefit but are cheaper by 30% to 40%

Between December 2019 and July 2020, first-time generic applications were filed for ivabradine, rivaroxavan, dapagliflozin, ticagrelor, mecobalamin+pregabalin, canagliflozin, and tenofovir alafenamide.

Dapagliflozin and canagliflozin are medications for diabetes, while tenofovir alafenamide is a treatment drug for chronic hepatitis B infection and other liver ailments. The rest of the medicines are used to treat and prevent stroke, heart attack and blood clots.

“If FDA prioritizes release and evaluation of products like these, there will be more choices of medicines in the market,” Herrera added. “More options means lower cost.”

Herrera explained that if the Anti-Red Tape Act (ARTA) of 2018 would be strictly followed, “these applications are already deemed automatically renewed.”

“It is important to point out that these products are not new in the market as they were already tested for safety, efficacy and quality. The public has been using these products for some time so there’s little to no risk already,” Herrera also pointed out.

Source: Latest Politics News Today (Politics.com.ph)