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Saturday, December 2, 2023

Speaker to FDA: Expedite local drug production

Speaker Lord Allan Velasco on Monday appealed to the Food and Drug Administration to hasten its procedures, specifically concerning the applications of local pharmaceutical companies for Certificate of Product Registration (CPR) and Emergency Use Authorization (EUA) permits.

Velasco said the local pharmaceutical industry “plays a vital role in helping provide much-needed medicines for the prevention and treatment of COVID-19.”

“While we understand the need for thorough study of drugs and medicines, we need to balance it out by making compliance easier for local pharmaceutical firms by cutting out unnecessary red tape and redundant requirements,” the Speaker said.

“There are countless reports of local drug manufacturers whose products have been stuck in regulatory limbo for years. These bureaucratic impediments are something that we need to eliminate, especially during a public health crisis,” he added.

Deputy Speaker Bernadette Herrera echoed Velasco’s view.

“The spectrum of medical therapies to treat COVID-19 is growing and evolving rapidly, and the FDA has actually allowed some of these therapies to be used for emergencies,” she said.

“Sadly, while they can be prescribed by doctors, these medicines are often impossible to obtain. Local manufacturers are ready, willing, and able to produce them, but it takes the FDA an inordinately long time to process and approve their requests.”

Based on computations from the current FDA checklist, Herrera said it will take a company a minimum of eight months to complete the requirements needed for the issuance of a CPR.

According to business insiders, however, CPRs usually take far longer than that, if they are even issued at all.

“Even from a trade and industry perspective, it is alarming that a number of local pharma producers have actually been forced to close, simply because they could no longer afford to wait for the FDA to grant them their permits,” Herrera said.

“Can you just imagine how much this dilemma is magnified, now that actual lives are at stake?” 

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