Solons urge FDA to cut red tape, expedite procedures for local drug manufacturers

Published April 18, 2021, 11:29 PM

by Hannah Torregoza 

House Speaker Lord Allan Velasco on Sunday urged the Food and Drug Administration (FDA) to expedite the process for local drug manufacturers applying for permits for Certificate of Product Registration (CPR) and Emergency Use Authorization (EUA). 

(MANILA BULLETIN FILE)

Velasco said he was looking to the local pharmaceutical industry to boost the country’s response against the coronavirus (COVID-19) pandemic given the lack of vaccines and medicines needed to address the crisis.

“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. 

“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 lamented.

Velasco said these local companies actually play a vital role in helping provide much-needed medicines for the prevention and treatment of COVID-19.

Deputy Speaker Bernadette Herrera echoed Velasco’s sentiments, saying the “spectrum of medical therapies to treat COVID-19 is growing and evolving rapidly.”

The FDA, she pointed out, has actually allowed some of these therapies to be used for emergencies.

“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,” she added.

Herrerra pointed out that even from a trade and industry perspective, it was alarming that a number of local pharmaceutical producers have been forced to close because they could no longer afford to wait for the FDA to grant them their permits. 

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

The lawmaker said she believed the government could provide 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. 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 lawmakers can introduce direct grants under the proposed Bayanihan 3 to these local drug companies in the form of soft loans or credit subsidies, or tax relief.

“Now is the perfect time to look into these options, and to maximize our resources,” she stressed.

 
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