Senator Francis Tolentino is seeking to institutionalize the Food and Drug Administration’s (FDA) authority in issuing an emergency use authorization during public health emergencies.
Tolentino filed on Tuesday, January 26, Senate Bill No. 2024, wherein he pointed out the lack of a law that provides for the grant of EUA.
“A reading of [Republic Act] No. 3720, as amended, and its Implementing Rules and
Regulations, do not provide for or contemplate the grant of EUA by the FDA,” he said in explaining the bill, referring to the Food, Drug and Cosmetics Act, which created the FDA.
Neither the Bayanihan 2 Law (Republic Act No 11494) authorizes the FDA to issue EUAs to pharmaceutical companies, he added.
In a privilege speech last week, Tolentino hit the FDA for its “unauthorized discretion” for issuing circulars giving itself the authority to issue EUAs, describing it as “a classic case of undue delegation of legislative powers.”
While President Duterte issued last December an executive order authorizing the FDA director general to grant EUA for COVID-19 vaccines, Tolentino said “it could be argued that this is insufficient to clothe the said agency with the authority to do so.”
He said executive orders “cannot amend, revise, repeal, or in any way, alter what is stated under a law passed by Congress.”
Tolentino said such “glaring void” in the law might invalidate the FDA’s issuances and put the grant of EUAs for COVID-19 vaccines under legal scrutiny.
“Invalidating the EUA issuances and grants, however, in time of a public health crisis would be an impractical thing to do. It would result in unnecessary delays in the deployment of the much-needed COVID-19 vaccines for the Filipinos,” he said.
SB 2024 seeks to further amend the Food, Drug and Cosmetics Act, to define EUA and provide the parameters for its issuance.
Under the bill, the grant of EUA allows the use of unapproved health products “during a public health emergency or threat, to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternative health products.”
“The emergency use may either be for an unapproved health product or unapproved use of an approved health product,” the bill further stated.
The FDA director general may revise or revoke the EUA if the public health emergency no longer exists, if the criteria in the issuance are no longer satisfied, and if the revision or revocation is necessary to protect public health or safety.
His bill, he said, “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.”