Senate bill seeks to institutionalize FDA’s authority to issue EUAs
MANILA, Philippines — Senator Francis Tolentino has filed a bill seeking to institutionalize the authority of the Food and Drug Administration (FDA) to issue an emergency use authorization (EUA).
In filing Senate Bill No. 2024, Tolentino noted that existing laws “do not provide for or contemplate” the grant of EUA by the FDA.
While President Rodrigo Duterte earlier issued an executive order allowing the FDA to issue EUAs for Covid-19 drugs and vaccines, the senator said “it could be argued that this is insufficient to clothe the said agency with the authority to do so.”
Executive orders, Tolentino noted “cannot amend, revise, repeal, or in any way, alter what is stated under a law passed by Congress.”
In order to address the “glaring void” in the law that would deem the FDA’s EUA issuances “subject to stricter legal scrutiny,” the bill seeks to amend the Republic Act No. 3720 or the Food, Drug and Cosmetic Act to define EUA and provide the parameters for its issuance.
“The proposed measure not only gives legitimacy to the circulars issued by the FDA on EUA but also ensures the faster and smoother procurement and distribution of vaccines to the Filipino people during a public health emergency,” Tolentino said.
Under the measure, an EUA is defined as an authority issued by the FDA chief allowing the use of unapproved health products during a public health emergency or threat or when there is no “adequate” or approved product to treat “serious or life-threatening diseases or conditions.”
“The emergency use may either be for an unapproved health product or for an unapproved use of an approved health product,” the bill said.
The measure also mandates the FDA, in consultation with the Department of Health, Department of Science and Technology and other relevant agencies to issue “emergency use instructions” to “inform health care providers and individuals, to whom an eligible product under this Act is to be administered, concerning such product’s EUA.”
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