FDA urged to expedite procedures for EUA permits of local pharma firms
MANILA, Philippines — House Speaker Lord Allan Velasco has appealed to the Food and Drug Administration (FDA) to expedite its procedures, especially those concerning the applications of local pharmaceutical firms for product registration and emergency use authorization (EUA) permits amid the pandemic.
In a statement Sunday, Velasco said the local pharmaceutical industry can boost the country’s capability in its battle against the pandemic, saying such firms “play a vital role in helping provide much-needed medicines for the prevention and treatment of COVID-19.”
“While we understand the need for a 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,” he 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 shared 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,” Herrera 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,” she added.
Citing computations from the current FDA checklist, the lawmaker said it would take a company a minimum of eight months to complete the requirements needed for the issuance of a Certificate of Product Registration (CPR).
But business insiders have said that CPRs usually take far longer than that, if they are even issued at all, Herrera further noted.
“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,” she lamented.
“Can you just imagine how much this dilemma is magnified, now that actual lives are at stake?” she added.
Further, she broached the idea of instituting government support for the local pharmaceutical 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. We should throw our support behind these local pharma companies because the ripple effect will benefit public health, job creation, and overall economic activity,” 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 added.
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