MANILA, Philippines — The Food and Drug Administration (FDA) appeared to have exercised powers beyond the mandate of the law, causing delays and confusion in the country’s procurement of COVID-19 vaccines, according to Sen. Francis Tolentino.
In his privilege speech on Tuesday night titled “Unauthorized FDA discretion,” Tolentino stressed that the FDA could not prohibit the private sector, local government units (LGUs) and other groups from acquiring the urgently needed vaccines based on the agency’s circulars pursuant to the laws passed by Congress.
“So what is happening now is that the FDA issued circulars, left and right, and thereafter belatedly amended its circular to include the words ‘Emergency Use Authorization (EUA).’ It then interpreted its own circulars which it would implement,” he said.
“I am not trying to demean the FDA, but it appears that the FDA is now the legislator, executive and judge as the sole interpreter of the circulars it issued,” he added.
The senator explained that before Dec. 14 last year, the FDA issued several circulars allowing the procurement by the private sector and non-government-controlled or decentralized procurement of vaccines.
The issuances include FDA Circular 2020-12-A, dated July 27, 2020 and Circular 2020-12-B, titled “Further Amendment to FDA Circular 2020-12 entitled Guidelines for Registration of Drug Products under Emergency Use for the Coronavirus Disease 2019” dated Aug. 26, 2020.
The FDA, however, issued Circular 2020-036, titled “Guidelines on the Issuance of Emergency Use Authorization,” which amended all previous circulars, last Dec. 14. – Sheila Crisostomo, Cecille Suerte Felipe, Ghio Ong
