FDA approval on drug, vaccine possible in 40 days or less with EUA —official

Food and Drug Administration (FDA) approval of a drug or vaccine can be expected in 40 days or less now that it is allowed to issue emergency use authorization (EUA), Dr. Jaime Montoya of the Philippine Council for Health Research and Development (PCHRD) said Thursday.

Without EUA, Montoya said the process usually takes about six months.

"Yung normal na proseso, yung walang EUA, umaabot ng anim na buwan bago aprubahan," Montoya, PCHRD's executive director, told Super Radyo dzBB.

"Kung may EUA, according to FDA, puwedeng 40 days or less pa, depende kung gaano kakumpleto ang mga dokumentong isa-submit [ng developer]."

He added that the process will also be faster for drugs or vaccines that have been given EUA in other countries.

Approval, however, is not automatic, according to Montoya, stressing that the FDA can reject drugs or vaccines that pose more risks than benefits, or even pull them back if ever they are already in the market.

"Kung mas marami ang risks kaysa benefits, hindi maaaprubahan 'yan," the official said.

On Wednesday, Malacañang announced that President Rodrigo Duterte, through Executive Order 121, has allowed the FDA to issue an EUA for COVID-19 drugs and vaccines.

The issuance of an EO on EUA was proposed by Health Secretary Francisco Duque III and vaccine czar Carlito Galvez Jr.

Montoya said EUA can only be issued during a period of public health emergency. "Magagawa lang 'yan kapag may public heath emergency tulad ngayon," he said, referring to the current COVID-19 pandemic.

Montoya said the FDA can issue an EUA on a potential drug or vaccine even when clinical trials are not yet finished.

"Kahit di pa tapos ang trial, puwede na i-submit ng developer ang datos para maisyuhan sila ng EUA," he said.

PCHRD is an attached agency of the Department of Science and Technology (DOST).  —KBK, GMA News