MANILA, Philippines — The Food and Drug Administration (FDA) welcomes the intention of the members of the House of Representatives (HOR) to investigate the process on the issuance of permits for drugs specifically the ones that show potential in combatting coronavirus disease (COVID-19).
During the Laging Handa briefing on Tuesday (April 20) FDA Director-General Eric Domingo stated that the agency has a set of standards on issuing approval on applications for Certificate of Product Registration (CPR) and Emergency Use Authorization (EUA).
“Mayroon naman tayong set ng policies at mga standard na sinusunod bago mag-approve po ng isang gamot kasama na ang safety, quality, and evidence on efficacy,” Domingo said.
Domingo said the investigation will help the FDA explain the measures it applies in expediting the country’s access to medicines, diagnostic kits, and other medical needs.
This, after House Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera-Dy filed House Resolution (HR) 1711 that calls on the Committee on Good Government and Public Accountability to look into the policies and guidelines for the registration, utilization, [manufacturing], distribution, and sale of drug products “which appear to be detrimental to public interest”.
Earlier, Velasco also urged the FDA to speed up the process of acquiring permits for local drug manufacturers after the government opened opportunities for the local pharmaceutical industry to boost the country’s response against COVID-19 in addressing the need for vaccines and medicines crisis.
During the briefing, Deputy Speaker Dy pointed out that there seems to be a problem with the process.
“Nakita natin na parang arbitrary kung paano nila pinapakinggan ang WHO or ‘yung iba mabilis ang approval, ‘yung iba matagal,” she said.
“Noong nakausap ko ang mga local pharmaceutical companies natin, they can make the tocilizumab, the remdesivir, pero it seems na nahihirapan silang magpa-register dito mismo sa ating bansa,” she added.
“Marami naman tayo mga foreign clinical trials na pwede nating gamiting basis. Iba kase yung available na siya sa market. Tandaan mo pag sinabi mong compassionate special permit these are for those na malubha na sa ospital. Papaano yung pang prophylactic niya? Paano yung pang prevention niya? Yun yung gusto nating patingnan sa FDA. Baka pwede nilang tingnan sa portion na ito and to make it available,” Dy further said.
For the part of the FDA, Domingo said any investigation would give the agency an avenue to explain their side on the matter.
“We welcome this para pa-explain natin sa ating mga mambabatas kung ano ang ating mga proseso at saka kung ano na ang nagawa natin sa FDA simula ng pandemic,” he said.