FDA wants more flexibility on experimental drugs during emergencies
MANILA, Philippines — The Food and Drug Administration (FDA) said Thursday that it needs a new law to give it more flexibility in regulating experimental drugs during emergencies like the coronavirus pandemic.
This was FDA Director General Eric Domingo’s response during a congressional inquiry when quizzed by Deputy Speaker Bernadette Herrera-Dy (Bagong Henerasyon party-list) about the possibility of adding more drugs for emergency use for the treatment of COVID-19.
Herrera-Dy is among the lawmakers pushing for the use of ivermectin against COVID-19. She has said that she takes the drug, which a doctor prescribed for her.
“Of course we are exploring possibilities,” Domingo told House lawmakers. “In the Philippines … we don’t have a law for emergencies. Our law, RA 9711, thinks as if we are always performing our regular everyday activities without an existing emergency in the country.”
Domingo was referring to Republic Act No. 9711, or the law that created the FDA.
He went on to explain that currently, the FDA is only able to issue Emergency Use Authorizations using President Rodrigo Duterte’s Executive Order No. 121, which allowed the regulator to approve COVID-19 vaccines for emergency use.
“Kailangan ho talaga ng FDA ng mas flexibility, lalo na kapag panahon ng emergency,” he said.
(The FDA really needs flexibility, especially during times of emergency.)
There are bills currently pending in the House and in the Senate which institutionalizes the FDA’s power to grant emergency use authorizations.
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