FDA chief seeks law to provide flexibility to regulations during emergencies

FDA chief and DOH Usec. Eric Domingo

MANILA, Philippines — The Food and Drug Administration (FDA) is seeking the approval of measures that will allow it to have more “flexibility” in its regulations in times of emergencies.

FDA Director General Eric Domingo made the remark Thursday during a House hearing of the committee on good government and public accountability on the guidelines of the FDA and the Department Health (DOH) for COVID-19 drug registration, distribution, and sale sought.

Some lawmakers said some of the guidelines have become “detrimental” in the fight against the pandemic.

“‘Yun nga po ang hinihiling namin kasi ang batas ng FDA para talagang walang emergency lagi kaya ang hinihiling namin sa lehislatura na talagang susuportahan namin ang bigyan ng kapangyarihan ang FDA sa panahon ng mga emergency para magkaroon tayo ng kaunting flexibility sa ating regulation,” Domingo said.

In December 2020, President Rodrigo Duterte allowed the FDA to grant emergency use authorization (EUA) to expected COVID-19 vaccines that will be made available in the Philippines.

Duterte gave the FDA such power through Executive Order No. 121.

An executive order was issued since current FDA laws do not allow the agency to issue EUA. Bills granting FDA to grant EUA during emergency situations are still pending in the House and the Senate.

“Sa Pilipinas kasi, wala tayong batas for emergencies. Ang ating batas, yung R.A. 9711 parang iniisip nya lagi tayong nasa regular na everyday activities na walang emergencies sa Pilipinas,” Domingo said, referring to Republic Act No. 9711 or the “Food and Drug Administration (FDA) Act of 2009.”

“The only executive order that allows us for the EUA [emegency use authorization] is the [Executive Order] 121 of the President kaya nakapagbigay kami ng EUA sa mga ating mga bakuna,” he added.

EDV