FDA gives in to lawmakers, OKs ivermectin for ‘compassionate use’

The Food and Drug Administration (FDA) granted an application for “compassionate use” of anti-parasitic drug ivermectin on humans with COVID-19, FDA Director General Eric Domingo said on Thursday.

“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,” Domingo said in Filipino at an online briefing.

Ivermectin was earlier only allowed for use on animals.

Despite the compassionate use authorization, the distribution of ivermectin as part of treatment for COVID-19 is still prohibited, Domingo said.

Domingo 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.

Domingo has earlier clarified that such a compassionate use permit is different from the pending application of two local manufacturers seeking for a 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.

Several 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, 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 for this product.

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

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 to the legalities of the issues and the other thing is morality,” he said.

Before 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 about 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.

Lawmakers who advocate the use of ivermectin as alternative treatment for COVID-19 patients on Thursday hailed as a “step in the right direction” the decision of the FDA’s grant of a compassionate special permit for ivermectin’s use.

“We are glad that the FDA is finally taking a step in the right direction as people desperately seek a cure for COVID-19 in the wake of surge in new cases and rising death toll,” House Deputy Speaker Bernadette Herrera said.

Herrera of Bagong Henerasyon party-list group lawmaker expressed hope this latest development would soon prompt the FDA to grant an emergency use authorization for ivermectin as COVID-19 drug, using as basis the “encouraging” results of clinical trials conducted in Australia, Japan, Panama and United States.

Defensor shared Herrera’s view, saying the move of the FDA “is a step forward in combating the dreaded disease and in helping our people address this pandemic.”

The Department of Health, FDA and even the World Health Organization said studies and clinical trials have yet to prove its efficacy and safety in treating viral infections in humans.

Herrera, meanwhile, called out the Philippine National Police (PNP) and its Criminal Investigation and Detection Group (CIDG) over a memorandum ordering the arrest of persons involved in the illegal sale and use of ivermectin.

“Ivermectin is not an illegal drug,” Herrera said. “You cannot ban its use. It is our right to take care of ourselves as we fit it.”

Herrera issued the statement after the CIDG Headquarters came out with a memorandum directing its regional and special operating units to coordinate with the FDA in the conduct of police operations against sellers and users of ivermectin.

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