FDA looking into ‘ivermectin pantry’ loopholes

CNN – Published Apr 30, 2021 4:01:27 PM

Metro Manila — The Food and Drug Administration on Friday said it will review issues with the so-called “ivermectin pantry” wherein two lawmakers gave away free capsules of the antiparasitic drug.

FDA Director General Eric Domingo earlier gave his go-signal for Anakalusugan Rep. Mike Defensor and SAGIP Rep. Rodante Marcoleta to hold their ivermectin giveaway as long as a doctor will give prescriptions for compounded ivermectin.

However, doctors at the event on Thursday issued haphazard prescriptions. The prescriptions were written in a blank bond paper that did not have the issuing doctor’s name and tax receipt number — a requirement under the country’s laws.

Health Secretary Francisco Duque, in a television interview, said the FDA should investigate these incidents. He added that the doctor who issued prescriptions “must answer for his actions.”

Domingo said they are in the process of doing that.

“Our regulatory enforcement unit is looking into the situation,” he told CNN Philippines.

Defensor argued the prescriptions are a “non-issue” since it’s easy to identify which of the four doctors in the event gave the drugs.

The Department of Health said it is also ready to launch an investigation if needed.

“Let’s all move on from this issue. Kung ano ang nangyayari dito ay gagawan natin ng imbestigasyon kung kinakailangan [We will investigate if necessary],” Undersecretary Maria Rosario Vergeire said.

The day before the event, DOH and FDA gave differing opinions on the legality of the ivermectin giveaway event. DOH said hospitals granted compassionate special permits are the only ones allowed to dispense the drug to patients, while Domingo said the event is allowed as long as a doctor will prescribe the compounded ivermectin.

This has led also to confusion in the Quezon City local government, which approved the event.

The LGU urged the DOH and FDA to issue a “clear stand” on use of ivermectin against COVID-19. It said it could not prohibit the “ivermectin pantry” launched by Reps. Mike Defensor and Rodante Marcoleta in the city because the FDA has not categorically said it was illegal.

Vergeire said there are two “pathways” to any decision related to medicine: Regulatory, which is the responsibility of FDA, and a clinical pathway taken by the DOH and other medical experts.

The FDA, DOH, and several health experts, including the World Health Organization, have cautioned the public against using ivermectin for COVID-19 prevention or treatment.

Experts said there is not enough proof the drug can be used to treat or prevent COVID-19. They also warned high doses could cause brain damage in humans, or even death.

SOURCE: https://cnnphilippines.com/news/2021/4/30/Ivermectin-pantry-Defensor-Marcoleta-FDA-investigation.html???

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