Ivermectin distribution issue: Loophole is defense for Defensor, et al. – DOJ

By: Tetch Torres-Tupas – Reporter

On its face, the distribution of anti-parasitic drug Ivermectin for treatment of COVID-19 violates the Food and Drug Administration (FDA), Justice Secretary Menardo Guevarra said Thursday.

The FDA  has never approved Ivermectin for human use. While it has granted a compassionate special permit for its use for COVID-19, it was only given to a handful of hospitals. Even the Department of Health said Ivermectin should only be for hospital use only.

“Under FDA existing law, the importation, sale, distribution or administration of unregistered drugs or vaccines are prohibited and accordingly punished. Ivermectin is not registered for use by humans because apparently, it is for the parasitic disease of animals,” Guevarra explained in an interview over ANC Headstart.

“In the case of Ivermectin, it is not registered particularly as a drug against COVID-19 and going by the FDA Law on its face. It would appear that the distribution of Ivermectin as a possible treatment for COVID-19 apparently violates the FDA law,” he added.

On Thursday, Deputy Speaker Rodante Marcoleta and Anakalusugan Rep. Mike Defensor proceeded with the distribution of Ivermectin in Quezon City.

In allowing Ivermectin use for humans, the FDA has provided exemptions:

1. When it is covered by a compassionate use authorization issued to specific hospitals, doctors, or other entities; and

2. When Ivermectin is compounded by duly licensed pharmacies, and it’s usually supported by a doctor’s prescription.

Guevarra said if Defensor and Marcoleta’s act would fall under the exemptions “it would appear that they can put this up as a defense just in case a complaint is filed against them.”

“But personally, I’m not too sure whether these two exemptions cited by the FDA director-general, have a sound legal basis so that is something that is for further study. I’m not too sure about the soundness of the legal basis for the exemptions,” Guevarra said.

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