Another hospital allowed compassionate use of ivermectin vs. COVID-19 —Domingo

Food and Drugs Administration (FDA) Director General Eric Domingo on Friday said another private hospital has been granted compassionate special permit (CSP) to use the anti-parasitic drug ivermectin as treatment for COVID-19.

"Two hospitals na actually na nag-apply sa atin ang nabigyan ng CSP [two hospitals have actually applied and granted CSP already]," Domingo said on ANC.

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

"I have to ask permission from the hospitals kasi may privacy kasi yung mga pasyente nila [because of the privacy of their patients]," he said.

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.  Domingo previously explained 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 treatmenet" 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.

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.   

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 (WHO), the US Food and Drug Administration, the European Medicines Agency (EMA) 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, saying 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. 

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

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 against unregulated drugs. Ang binabawal namin, unang-una, ‘yung pag-reseta ng gamot na pang-hayop sa tao. Bawal kasi talaga ‘yun. Bawal din mag-reseta ng gamot na hindi registered,” he added.

(What the FDA is against is against unregulated drugs. What we don’t allow is the prescription of a veterinary drug to humans and the use of unregistered drugs.)  

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 (CPR).—with Julia Mari Ornedo/KBK, GMA News