Why did it have to be so complicated? FDA urged to improve process for approving COVID-19 drugs
Speaker Lord Allan Jay Velasco on Sunday appealed to the Food and Drug Administration (FDA) to improve the efficiency and promptness of its procedures on the applications of local pharmaceutical companies.

Why did it have to be so complicated? FDA urged to improve process for approving COVID-19 drugs

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By Billy Begas

Speaker Lord Allan Jay Velasco on Sunday appealed to the Food and Drug Administration (FDA) to improve the efficiency and promptness of its procedures on the applications of local pharmaceutical companies.

“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,” Velasco said.

Velasco said that 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.

Local pharmaceutical companies, Velasco said “play a vital role in helping provide much-needed medicines for the prevention and treatment of COVID-19.”

Based on FDA checklist, it will take a company a minimum of eight months to complete the requirements needed for the issuance of a Certificate of Product Registration (CPR).

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. 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.”

Herrera is vocally supporting the use of Ivermectin to COVID-19 patients citing clinical trials in other countries.

She said there were local pharmaceutical producers that were forced to close, “simply because they could no longer afford to wait for the FDA to grant them their permits.”

“There is an actual and realistic opportunity for us to produce our own medicines, that are at par with the ones we are importing. 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 pointed out.

Herrera said soft loans or credit subsidies can be provided to these companies under the proposed Bayanihan 3.

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