FDA grants ivermectin special permit to another private hospital

posted April 17, 2021 at 01:10 am
by  Willie Casas and Maricel V. Cruz
Food and Drugs Administration Director General Eric Domingo said Friday one more private hospital was granted a compassionate special permit (CSP) to use the anti-parasitic drug ivermectin as treatment for COVID-19, as the country grapples with a shortage of supplies of medicines and vaccines.

“Two hospitals have actually applied and granted CSP already,” Domingo told ANC in an interview.

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.

The first CSP for the use of ivermectin on COVID-19 patients was granted by the FDA last week.

Due to privacy concerns, Domingo said he could not bare the name of the hospitals.

“I have to ask permission from the hospitals because of the privacy of their patients,” he said.

The Department of Health DOH had repeatedly warned that dispensing of ivermectin for human use as well as its promotion violate Republic Act 9711 or the FDA Act of 2009.

Domingo had said that under a CSP, patients must consent to using the drug and doctors take upon themselves “complete responsibility over the product.”

Domingo said their requirements for granting CSP are name of the licensed importer and proof of registration of ivermectin from its country of origin.

The FDA should also be informed of the “investigational treatment” that the hospital will be following in the use of ivermectin against COVID-19.

“Hindi naman puwedeng mag-iimbento ka ng dosage, imbento ng protocol (you can’t just invent dosage and protocols),” Domingo said.

In the United States, ivermectin is used in mild to moderate cases of COVID-19, he said.

Doctors who will use ivermectin against the coronavirus will be reporting to the FDA on a monthly basis, he said.

Amid the push of some sectors, including lawmakers, for the use of ivermectin against COVID-19, the Philippine Association of Pharmacists in the Pharmaceutical Industry (PAPPI) said clinical trials are needed to assess its benefits and risks.

The World Health Organization, the US Food and Drug Administration, the European Medicines Agency have all said there is currently a lack of data on ivermectin’s efficacy and benefits as a COVID-19 treatment.

The FDA earlier said that despite the approval, ivermectin’s distribution is still prohibited, as the agency 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 clarified that the Philippine FDA is not against ivermectin.

“We recognize that it is a drug under investigation… there is a possibility that it would be proven to be good for COVID-19, there’s a possibility that it would be proven to be useless against COVID-19,” he said.

“What the FDA is against is unregulated drugs. What we don’t allow is the prescription of a veterinary drug to humans and the use of unregistered drugs,”he said.

Domingo stressed that “there is a legal way” to use ivermectin in the Philippines, which is through a CSP or a certificate of product registration.

Meanwhile, a party-list lawmaker chided the Department of Health for preferring two costly investigational COVID-19 therapeutics over what he described as inexpensive “wonder drug” ivermetin that the poor can afford.

“The DOH continues to spend hundreds of millions, maybe billions, of pesos to buy Remdesivir and Tocilizumab, not to mention the purchases of private hospitals,” Anakalusugan Rep. Mike Defensor said.

He cited the recent statement of treatment czar DOH Undersecretary Leopoldo Vega that new imported stocks of the two therapeutic products were due to arrive in the country to replenish dwindling supply.

Defensor said Remdesivir costs P28,000 for 2 shots daily (for about 3-5 days) while the price of Tocilizumab is about $2,000.

In contrast, he said ivermectin, which is also an investigational drug like its two more expensive rivals, costs only P35 per tablet.

He said for DOH hospitals, it is Philhealth that shoulders the price of Remdesivir and Tocilizumab, while for private hospitals, the cost “is borne by desperate private citizens who try to save their sick loved ones.”

He added that the DOH and the FDA were allowing the use of Remdesivir against the advice of the World Health Organization.

“We were part of the WHO solidarity trial and yet we do not follow their recommendations and continue to allow Remdesivir to be given to COVID-19 patients. For Remdesivir, we don’t follow and DOH continues to purchase it, but for Ivermectin, where data is still inconclusive and clinical trials are allowed, the DOH and the FDA crack down on supply,” Defensor stressed.

He said ivermectin is listed in the WHO, Philippine FDA and US FDA list of essential drugs.

“It is considered a wonder drug, along with penicillin and aspiring. It is one of the safest, with a testimony spanning 40 years. It has a 3.7 billion dosage on record,” he said.

He admitted that ivermectin “is not a registered drug, but that’s because for many years, it was donated for river blindness and other parasitic illnesses.”

“Can the DOH and FDA allow its production? Yes, in the same manner that they have allowed the expensive drugs to be used. An administrative order (AO) allowing drug manufacturers to produce Ivermectin can be issued. The AO would allow them to import legally without facing arrest and confiscation of products given the current policy of the DOH and the FDA,” he said.

Defensor said the poor could easily afford the P35 ivermectin.

“We can save many lives without draining government and Philhealth coffers or making families, including the poor, pay huge sums for the hospitalization of their loved ones,” he said.

Topics: ​Food and Drugs Administration , Eric Domingo , COVID-19 , ivermectin
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