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PRESS RELEASES

SOURCE: Press and Public Affairs Bureau


HOUSE URGES FDA TO EXPEDITE PROCEDURES FOR LOCAL DRUG MANUFACTURERS
18 April 2021 06:13:47 PM


Speaker Lord Allan Velasco is looking to the local pharmaceutical industry to boost the country’s capability in the fight against the pandemic, saying that local companies “play a vital role in helping provide much-needed medicines for the prevention and treatment of COVID-19.”

Accordingly, Velasco appealed to the Food and Drug Administration (FDA) to improve the efficiency and promptness of its procedures, specifically concerning the applications of local pharmaceutical companies for Certificate of Product Registration (CPR) and Emergency Use Authorization (EUA) permits.

“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 House leader said.

He added: “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.”

Deputy Speaker Bernadette Herrera echoed Velasco’s sentiments. "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,” Herrera said. “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, 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 lamented. "Can you just imagine how much this dilemma is magnified, now that actual lives are at stake?"

The party-list solon further brought up the possibility of instituting government support for the beleaguered industry. “There is an actual and realistic opportunity for us to produce our own medicines, that are at par with the ones we are importing,” Herrera pointed out.

“We should throw our support behind these local pharma companies, because the ripple effect will benefit public health, job creation, and overall economic activity,” she added.

Herrera said this can be done through direct grants from Bayanihan 3, soft loans or credit subsidies, or tax considerations. “Now is the perfect time to look into these options, and to maximize our resources," she concluded.#