Ivermectin’s compassionate use permit should be issued per patient –ex-DOH chief

Former Health Secretary Dr. Paulyn Ubial on Friday said the Food and Drug Administration’s (FDA) compassionate use permit for anti-parasitic drug ivermectin should be issued per patient.

In an interview with Balitanghali, Ubial explained that the permit issued to the hospital does not give them “blanket authority” to use ivermectin on other patients.

“Ang application [ng compassionate use permit] niyan is per patient so common po ‘yan ng isang hospital lang kasi isa-isa lang ang consideration. Hindi po siya blanket authority,” she said.

[The compassionate use application is per patient, and it is commonly issued to a hospital because the consideration is for every patient. It is not a blanket authority.]

The FDA’s recent approval of compassionate use of ivermectin is also a “common practice” and a “normal” process, she added.

According to Ubial, there were no published studies on ivermectin’s use on humans and for COVID-19.

She reiterated that anecdotal reports cannot be a basis for the efficacy of ivermectin as a COVID-19 cure.

“Kaya pinayagan ‘yan kasi it has to be proven to be safe if there is no adverse effect to the body then you can take it. Whether it can cure COVID or not, that’s another question,” she said.

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

Despite the approval, the FDA said its distribution was still prohibited, and only the hospital that has the permit for ivermectin’s compassionate use would be allowed to import the drug through a licensed importer.

FDA director-general Eric Domingo earlier clarified that such a compassionate use permit was different from the pending application of two local manufacturers seeking 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. — Hana Bordey/DVM, GMA News