FDA grants compassionate use permit for ivermectin vs. COVID-19

The Food and Drug Administration (FDA) has granted a hospital’s application for "compassionate use" of anti-parasitic drug ivermectin on humans with COVID-19,  Director General Eric Domingo said Thursday.

“Na-grant na iyong special permit for compassionate use [of ivermectin] kasi alam naman namin na investigational product ito against COVID-19. May isang ospital na nag-apply for compassionate use at na-grant na nga ng araw na ito,” Domingo said during Laging Handa briefing.

(The special permit for compassionate use of ivermectin on humans has been granted because we know that this is an investigational product against COVID-19. A hospital applied for such a permit and it was granted today.)

Prior to this, ivermectin is only allowed for use on animals.

READ:  What the WHO, US FDA, other health agencies say about ivermectin for COVID-19

But despite the compassionate use, distribution of ivermectin as part of treatment for COVID-19 is still prohibited, Domingo said in a separate interview on Super Radyo dzBB.

He said only the hospital that has the permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

"Yung ospital ang bibili, meron siyang licensed importer na magi-import para sa kaniya nitong gamot na ito na rehistrado sa ibang bansa," he said.

The FDA chief has earlier clarified that such a compassionate use permit is different from the pending application of two local manufacturers seeking for certificate of product registration for ivermectin.

A compassionate use permit only allows legal administration of the drug in the country but is not an endorsement of its safety and efficacy from the FDA.

A certificate of product registration, on the other hand, will allow manufacturers to sell the drug commercially and is an FDA guarantee that the drug is safe and effective.

A number of lawmakers and even doctors are pushing for prescribing ivermectin on COVID-19 patients, citing anecdotal experiences.

The FDA, however, maintained that ivermectin should be registered with FDA first before prescribing it to humans.

Meanwhile, earlier in the day, health reform advocate Dr. Tony Leachon urged the FDA to take a strong stand on the use of ivermectin as a treatment drug for COVID-19.

“The FDA as the highest regulatory agency should be strong in that regard,” Leachon said in an interview with ANC.

Leachon, former special adviser to the National Task Force against COVID-19, acknowledged FDA’s clear message on ivermectin’s safety and efficacy issues for human use as more studies are needed before it can be proven useful in treating COVID-19 cases.

He likewise backed calls to ban pharmacies from compounding ivermectin for human use, saying this will create a black market on this product.

Leachon further explained that the accountability is not assured if compounding of ivermectin for human use will be allowed in the country especially during health crisis like the COVID-19 pandemic.

“If you use that for compassionate use but not backup by science, by the regulatory documents that is a very weak position. You will be held liable just in the event had side effects, even in the context that the patients gave a consent,” he said.

He further appealed to politicians to “stay out of the health issues” and leave the matter to the FDA.

“You created the FDA and you have to trust them. We have to adhere the legalities of the issues and the other thing is the morality,” he said.

Prior to the FDA's announcement on Thursday, the Department of Health warned that dispensing of ivermectin for human use as well as its promotion violate Republic Act 9711 or the FDA Act of 2009.

This was their statement when asked  on the possible liabilities of some lawmakers who are advocating for ivermectin.

On Monday, Anakalusugan party-list Representative Mike Defensor announced that he would distribute ivermectin to treat patients infected with COVID-19 in Quezon City even if the medicine is still unregistered for human use. —KBK, GMA News