FDA to lawmaker: Distribution of unregistered drugs against the law


Posted at Apr 06 2021 08:41 AM | Updated as of Apr 06 2021 04:51 PM

Food and Drug Authority director general Eric Domingo and Anakalusugan Party-list Rep. Mike Defensor. ABS-CBN News/file

MANILA (2nd UPDATE) - The Food and Drug Administration said Tuesday the distribution of unregistered products is against the law.

FDA director general Eric Domingo made the remark following Anakalusugan Party-list Rep. Mike Defensor's plan to distribute anti-parasitic drug Ivermectin to COVID-19 patients and the elderly in Quezon City.

The drug is currently registered for use against worm infestations and parasites in animals.

"Kung unregistered po kasi bawal po talaga iyon o unauthorized. 'Di ko po alam baka meron silang compounding pharmacy na kausap na magrereseta at gagawin," Domingo told ABS-CBN's Teleradyo.

(If it's unregistered its distribution is prohibited or unauthorized. I don't know if they have a compounding pharmacy that will give prescription and make this drug.)

"Siguro alam naman po nila ano ang batas. Hintayin natin ang detalye. Meron naman pong pamamaraan na puwede pero pag unauthorized po hindi po talaga."

(They know the law. Let's wait for details. There's a way it can be distributed but if it's unauthorized it's really prohibited.)

The World Health Organization (WHO), European Medicines Agency, and the US FDA have all warned against the use of Ivermectin against COVID-19.

Ivermectin manufacturer Merck said there was no scientific basis showing that the anti-parasite drug is effective against COVID-19.

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Defensor, who has contracted and recovered from COVID-19, said he has coordinated with a compounding laboratory and that he would give away Ivermectin for free for those with prescription.

"I’m not doing anything outside of the law...Ako hanggang ngayon umiinom and I’m okay. (Former) Senator (Juan Ponce) Enrile drank it in public and he’s okay," he told ANC's Headstart.

(I still drink it and I'm okay.)

Ivermectin is "one of the safest drugs in the world," Defensor claimed as he asked the FDA to allow more laboratories to make the drug for those with prescription.

"I’m not imposing it on anyone. I have access and I can help them if they believe in Ivermectin," he said.

"I hope we can be more proactive in this campaign. Kasi ito ay P35 lang. Kung maraming matutulungan dito, maraming masasalba na buhay, malaking bagay para sa Pilipino."

(This costs only P35. If it can help many people and save many lives, it would be a big deal for Filipinos.)

Those who avail of Ivermectin will be required to give their consent, Defensor said.

"Before you're allowed to take it, may consent yung tao...it is an informed consent parang medical practice naman yan talaga," he told reporters when asked who will take responsibility for any side effects arising from the use of Ivermectin.

(Before you're allowed to take it, the person should consent...it is an informed consent, it's medical practice.)

"What I'm providing basically is an access...at ito naman ay di ko pinagbabayad, libre ko ito tinutulong sa ating mga kababayan. So what I'm doing now is within the process and within the parameters na ginawa ng (of) FDA at (and) DOH (Department of Health)."

(I'm not doing this for a price, I'm helping people for free.)

The FDA again warned the public against buying drugs online that have not been approved by the agency and were not recommended by the DOH.

"'Wag po tayong bibili ng 'di rehistrado na gamot dahil di po natin alam kung ano ang laman niyan," Domingo said.

(Do not buy unregistered drugs because we don't know what it contains.)

--With a report from RG Cruz, ABS-CBN News

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