DOH says ‘Fabunan Antiviral Injection’ still not registered with FDA, illegal to use

Kristine Sabillo, ABS-CBN News

Posted at Apr 28 2020 12:27 PM

MANILA — The Department of Health (DOH) on Tuesday reminded the public that the so-called Fabunan Antiviral Injection for COVID-19 has not even applied for registration and may not be used. 

During a virtual briefing with reporters Tuesday morning, Health Undersecretary Maria Rosario Vergeire said the public should be wary of drugs that have not been registered with the FDA. 

“Itong Fabunan, ang sinasabi nila bakuna ito, hindi ito gamot, na isinasaksak sa mga pasyente. Nung aming ipinaalalahanan para lang mag-apply na lang sa FDA para maintindihan na natin 'yung sinasabi, hindi naman nag-aapply po hanggang ngayon sa FDA,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing with reporters on Tuesday morning.

(This Fabunan, they say this is vaccine, not medication, being injected into patients. We reminded them to apply with the FDA so we may understand how it works but have not applied until now.)

“Hindi po nila pwedeng gamitin 'yan sa ating kababayan na walang pag-aaral na ginawa para masabi na ito ay tama o ito ay mali,” she said. “So kailangan po nilang iparehistro po 'yan para macheck natin. 'Wag gamitin kung hindi rehistrado.”

(They cannot use it on people without studying first if it’s good or not. So they have to register it so we can check. It can’t be used if it’s not registered.)

Vergeire said those who use the unregistered product on patients will be held liable.

Last April 8, the Food and Drug Administration already issued a statement explaining that “unlicensed products such as PRODEX B and the Fabunan Antiviral Injections have been informed regarding the process and requirements to register their products with the FDA Center for Drug Regulation and Research (CDRR).” 

It also warned the public against using such products with unproven claims.

Until now, there has been no approved cure or vaccine for COVID-19. The World Health Organization's office in the Philippines on Tuesday said it would take at least a year for a vaccine to be developed and distributed.