FDA chief: Special use permit for ivermectin is issued per patient

The Food and Drugs Administration on Saturday said that the compassionate special permit for the use of anti-parasitic drug ivermectin as COVID-19 treatment is issued per patient.

In an interview with "Dobol B TV," FDA director general Eric Domingo explained that an application is needed before the regulatory body can issue the compassionate special permit to a hospital.

“Lahat po ‘yan bawat ospital kumukuha ng compassionate special permit kasi kontrolado po sa CSP kung ilang tableta, kung kaninong pasyente nila gagamitin, kung saan manggagaling na bansa, ano ang registration sa bansa na ‘yon” (hospitals need to get a CSP and it is patient-specific), he said.

“Particular po ang compassionate special permit for each patient, for each hospital, and doctor,” he added.

Domingo made the remark after questions on the FDA’s approval of the compassionate special permit to a particular hospital were raised.

Moreover, Domingo said medicines that are currently approved for COVID-19 treatment such as the Remdisivir are also used under compassionate special permit.

The application for compassionate use permits can be filed before the FDA and it can be acted upon within 24 hours, he added.

On Friday, Former Health Secretary Dr. Paulyn Ubial also said the compassionate use permit on anti-parasitic drug ivermectin should be issued per patient.

Domingo reiterated that the compassionate use permit is different from certificate of product registration

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.

So far, the manufacturers that applied for certificate of product registration have not submitted any requirements to the FDA yet, Domingo said.

He added that the issuance of certificate of product registration for human-grade ivermectin does not mean it can be used as treatment for COVID-19.

It is the Department of Health that will decide on the treatment protocol for COVID-19, he noted.

Biz group pushes ivermectin use

In a separate interview on Dobol B TV, Employers Confederation of the Philippines (ECOP) President Sergio Ortiz-Luis Jr. echoed the appeals of other business groups to consider ivermectin as treatment for COVID-19.

He claimed that the approval on the use of ivermectin for COVID-19 treatment is facing government red tape.

“Payag na nga sila sa isang hospital na pwedeng gamitin, e 'di ibig sabihin pwede. Eh bakit binibigyan pa ng red tape eh maraming namamatay na Pilipino. Bakit hindi pa ibigay nang husto marami namang doktor ang humihiling na magreseta nito?” Ortiz-Luis said. 

Ortiz-Luis said the group of employers will consider giving ivermectin to their employees once it was approved by the FDA as this is cheaper than other medicines that are being studied for COVID-19 treatment.

On Thursday, the FDA granted a hospital’s application for "compassionate use" of ivermectin.

Despite the application's approval, the FDA said 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.

Several lawmakers and physicians are pushing for the use of ivermectin to treat COVID-19 despite opposition of some health experts.

Health experts warned that there is lack of evidence to prove that the drug can be a remedy for patients infected with COVID-19 despite articles and social media posts promoting Ivermectin as an anti-COVID-19 drug in Brazil, France, South Africa and South Korea.

The World Health Organization (WHO), the US FDA (Food & Drug Administration), European Medicine Agency (EMA), and even ivermectin manufacturer, Merck, all said there is lack of data and evidence of the efficacy and benefits for COVID-19 prevention and treatment. —LBG, GMA News