'Akala nila FDA is like a rubber stamp': regulator bemoans disregard for authority


Posted at Dec 31 2020 01:02 PM | Updated as of Dec 31 2020 02:05 PM

'Akala nila FDA is like a rubber stamp': regulator bemoans disregard for authority 1

MANILA - The Food and Drug Administration (FDA) on Thursday asserted its authority to regulate vaccines after high government officials admitted that members of the President's security detail got inoculated against COVID-19 despite lack of approval of the medicine from the regulator. 

“I think it's really a lack of appreciation. Akala nila FDA is like a rubber stamp. Yung FDA, it is an important unit of government because it deals with everything that we eat…processed food, household substances that we have and the medicines that we put into our bodies,” FDA Director General Eric Domingo said.

Domingo, in an interview on ANC’s Headstart said people working at the FDA are doing their jobs to protect the public and ensure a level of assurance that what people are using is safe and effective.

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 “Maybe people don’t understand that we're here not to make things difficult but to make things safe and effective for everybody,” he said.

He said there is no authorized COVID-19 vaccines in the Philippines at this time. As such, manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any unauthorized vaccine also remain prohibited.

The PSG on Wednesday admitted that some members of President Rodrigo Duterte’s close in security detail had been vaccinated against COVID-19 as early as September this year.

This, despite warnings from the Department of Health from using vaccines that are not registered with the FDA.

Duterte's spokesman urged the public to "just accept" that some soldiers were vaccinated against the COVID-19 while Interior Secretary Eduardo Año also said there was nothing illegal in the PSG's early inoculation. 

Defense Secretary Delfin Lorenzana said the vaccines against COVID-19 that were used by Duterte’s PSG were smuggled. But he believed the early inoculation of PSG members was justified.

“Somebody definitely did something wrong. With the FDA law, it says it is illegal to import, distribute, manufacture, use unregistered drugs.”

“This is usually what we do. Our regulatory enforcement unit, once we get news of illegal unregistered drugs or counterfeit drugs, we trace what happened, where it came from and then we do file cases against those who are responsible,” he said.

Lorenzana also called on the FDA to speed up the approval of vaccines.

But Domingo stressed that except for Pfizer, no other company has formally applied with the FDA.

“Wala naman po kaming i-aapprove. Hindi naman po kami nagbabagal kung ‘di wala pang nag-apply sa atin na magsu-supply sa Pilipinas o mag pa-approve sa FDA,” he said.

He said they cannot force companies to give their papers or samples of their vaccines to be tested.

As for Pfizer, Domingo said their vaccine expert panel and regulators are now evaluating the application for its emergency use authorization.

“The evaluation is going to take about 2 weeks. It was given to us right before Christmas. So I am giving evaluators up to the first week of January to do that. Of course, we have to consolidate the report,” he said.

The availability of the drug will not depend on the FDA, he said. “It will depend on the ability of the company to manufacture and supply to us,” said Domingo.

“Everybody is waiting for the COVID-19 vaccine but were not going to allow it unless we are sure that there is certain amount of reasonable scientific evidence to believe that it is safe and effective against COVID-19,” he said.


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