A HOUSE leader from the party-list bloc on Monday expressed grave concern over what she called “unnecessary delay” in the approval of first-time generic medicines for chronic diseases such as diabetes and hypertension, saying it is depriving people access to affordable life-saving drugs.

Deputy Speaker and Bagong Henerasyon (BH) party-list Rep. Bernadette Herrera also called out the Food and Drug Administration (FDA) for its delayed action on hundreds of applications for automatic renewal of certificate of product registration (CPR) filed by various pharmaceutical companies.

Herrera revealed that at least seven applications for first-time generics, which were filed as early as December 2019, have been allegedly “gathering dust” at the FDA, thereby preventing the timely availability of these affordable medicines in the country.

“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 marketed brand-name drug products 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.

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.

According to Herrera, the approval of these generic medicines is “incredibly important and highly beneficial to the public.”

Once these generic drugs reach the market, Herrera said earlier medicines becomes cheaper by 30 to 40 percent.

“The more competition, the lower the prices of medicines become,” the party-list legislator said.

Herrera urged the FDA to fast-track the approval of first generics, which process normally takes a maximum of six months.

The FDA, she said, should consider first generics to be important to public health and prioritize review of these submissions.

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

As to the automatic renewal submissions, Herrera said the applications should have been acted upon by the FDA within three days from its complete payment and submission of requirements.

“If we strictly follow the Anti-Red Tape Act (ARTA) of 2018, these applications are already deemed automatically renewed,” said Herrera, who was one of the authors of the ARTA law.

“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,” she added.

Earlier, the Philippine Chamber of Pharmaceutical Industry Inc. and the Philippine Pharmaceutical Manufacturers Association told a congressional hearing that a total of 1,025 applications for CPR, 18 for license to operate, and 381 for automatic renewal have been pending with the FDA as of last March 29.

For this, Bagong Henerasyon lawmaker also called out the Food and Drug Administration (FDA) for sitting on hundreds of applications for automatic renewal of certificate of product registration (CPR) filed by various pharmaceutical companies.

“Anu ba yan, ang daming pending at ang bagal ng aksyon. We hope the FDA will do something about this ASAP,” Herrera said.