Sanctions vs. PSG over unauthorized COVID-19 vax? FDA can't say yet

The Food and Drug Administration (FDA) cannot say yet if sanctions will be imposed on the members of the Presidential Security Group (PSG) who inoculated themselves with an unregistered COVID-19 vaccine.

FDA Director General Eric Domingo stopped short of saying that sanctions will be forthcoming even if PSG commander Brigadier General Jesus Durante III said they administered the unregistered COVID-19 vaccines to themselves way back in September and October.

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

“This is what we usually do. Our regulatory enforcement units, once we get news of unregistered or counterfeit drugs [being used in the country], we look for trails, we trace it where it came from and we file cases against those who are responsible,” he added.

Pressed if the FDA will have the courage to file cases against the PSG even if President Rodrigo Duterte did not do anything about it when he was informed of such vaccination of unregistered vaccine, Domingo did not give a categorical answer and instead assured that the FDA has competent investigators.

“Our regulatory enforcers are very good at doing investigations and I am happy that even Secretary (Menardo) Guevarra of DOJ has said they are going to send the NBI (National Bureau of Investigation) to investigate,” Domingo said.

“Our enforcement unit is going to work with the NBI and the Bureau of Customs so that we can find and trace where the lapses were and where the breach is in our regulatory process,” he added.

Defense Secretary Delfin Lorenzana said such vaccines are smuggled and then urged the FDA to speed up its approval of the COVID-19 vaccines.

Only Pfizer, however, has applied for an emergency use authorization (EUA) before the Philippine FDA. Pfizer submitted its EUA application to the FDA last December 24.

The vaccine that was used on the members of the military was Sinopharm as announced by no less than President Duterte. This, however, was not confirmed by Durante.

In closing, Domingo assured that the FDA will not get in the way of COVID-19 vaccines which are safe and effective.

“Maybe there is a lack of appreciation of what the FDA does. We are here not to make things difficult but to make this safe and effective for everybody,” Domingo said.

The Philippines has registered 472,532 COVID-19 cases so far.

Of this number, 439,509 recovered while 9,230 died. The number of active COVID-19 cases is at 23,793.—AOL, GMA News