Food and Drug Administration (FDA) director-general Eric Domingo on Thursday, April 22, appealed for a law that would allow the regulatory body to have "more flexibility" in its processes especially during emergencies.
During the virtual hearing of the House good government and public accountability on the Department of Health (DOH) and the FDA's policies for the registration of experimental COVID-19 drugs, Domingo pointed out the lack of a law that would allow the agency to further streamline its regulations during public emergencies.
"Wala tayong batas that's for emergencies. Ang atin pong batas, 'yong RA 9711, iniisip nila lagi tayong nasa regular, every day activities na wala pong emergency sa Pilipinas (We do not have laws that were meant for emergencies. Our current law, the Republic Act 9711, only covers regular, every day activities when there are no emergencies in the Philippines)," Domingo said, referring to the Food and Drug Administration Act of 2009.
Domingo further explaned that the measure that allows for the issuance of emergency use authoritization (EUA) of COVID, the Executive Order No. 121, only covers COVID-19 vaccines.
He said a law that would institutionalize such measures in times of emergencies is necessary.
"Kailangan po talaga ng FDA ng mas flexibity lalo na 'pag panahaon ng emergency at support the local pharmacetical industry (The FDA really needs more flexibility especially in times of emergency and to support the local pharmaceutical industry)," Domingo appealed to lawmakers.
Several House members have been calling on the DOH and the FDA to streamline their regulations for approving potential COVID-19 drugs, hitting its current guidelines as being "detrimental to public interest".
At present, the FDA could grant compassionate use permits for expedited access to investigational drugs. The agency said it already sped up the turn-around time for processing the applications.
Domingo reiterated that the FDA is doing everything under existing laws to fast track its processes.
"Ang gusto lamang po namin ay 'yong gamot na nadi-distribute ay sigurado lamang po tayo sa laman niya para po for everybody's safety, kaya kailangan lang pong dumaan sa proseso ng pagrehistro ng produkto (What we only want is to make sure that the contents of the drugs being distributed are safe, for everybody's safety, that's why they should undergo these processes of product registration)," he maintained.
Bills seeking to expand the FDA's authority to issue EUAs are pending in the Senate and the House of Representatives.