Lawmaker threatens legal action if 'ivermectin pantry' blocked

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Metro Manila (CNN Philippines, April 28) - A lawmaker on Wednesday vowed to fight the Food and Drug Administration in court if it blocks his plan to distribute the antiparasitic drug ivermectin for free.

Anakalusugan Party-list Rep. Mike Defensor and House Deputy Speaker Rodante Marcoleta are holding an "Ivermectin Pan-three" - inspired by the community pantry initiative - in Quezon City on Thursday. They will give away three capsules of the drug per beneficiary at no cost.

Defensor said those hoping to get ivermectin can present their medical prescriptions. If unavailable, there are doctors at the event who can prescribe it based on their medical information. He added the drugs will be made by a licensed compounding laboratory.

Defensor argued they will not be violating any law with the free distribution because it complies with FDA regulations. The lawmaker said FDA Director Eric Domingo himself told a recent Congressional hearing that the use of human-grade ivermectin capsules is allowed, as long as it is made by a licensed compounding laboratory with a doctor's prescription.

The congressman threatened legal action if the regulatory body issues an order against their event.

"I know I am not violating any law unless they would tell me otherwise... If they will again stop this initiative, I will fight them in court. Because legally, compliant kami [we are legally compliant]. On two occasions during the hearings, sinabi nila na ito ay pupwedeng proseso [they said this process is allowed]," he said.

The FDA chief said he has no objection to the planned ivermectin pantry as long as a doctor will check those in line before issuing a prescription.

Domingo supported Defensor's statement that lawmakers are not required to obtain a compassionate special permit as long as the medicines will come from licensed compounding pharmacies.

He stressed that the doctor giving the prescription will be held responsible for possible side effects from the drug.

"Lahat naman ng doctor may karapatan magreseta sa pasyente. Ang pasyente may karapatan magpatingin sa nanaisin nila. As long as assured ang safety ng pasyente then I do not see any problem with that," Domingo said in a separate interview.

[Translation: All doctors have the right to prescribe medicine. Patients can seek consultation. I don't see any problem with that as long as the safety of the patient is assured.]

The Health Department said only the five hospitals granted compassionate special permit by the FDA can "legally" distribute ivermectin. But Domingo said it's a different case because the hospitals apply for this permit so they can import the drug that is still unregistered in the Philippines.

He said if the compounded ivermectin was made by a licensed pharmacy then prescribed by the doctor then that is "legal."

"The FDA is not for or against any medicine. Ang bawal lang sa amin ay unregulated at unregistered [We only prohibit unregulated and unregistered drugs]," Domingo added.

Dr. Iggy Agbayani of the Concerned Doctors and Citizens of the Philippines estimates that over 100,000 people will be given ivermectin over the next few weeks. He said they will also regularly monitor the effect of the drug on the recipients.

"We are doing a clinical trial, pero hindi siya [but it is not] part of any big scheme to wait for," he noted. "Like any group of doctors, we want to know kung may impact 'yung gagawin [if this initiative will have an impact]."

Agbayani said they still expect there would be adverse effects from the drug, such as allergy, nausea, or diarrhea, but noted these are normal. He added recipients will be asked to register and report their health condition online or through their barangay officials.

Still no solid evidence on ivermectin vs COVID-19

The DOH maintained there is still no concrete evidence to show ivermectin is effective in treating mild to moderate COVID-19 infection.

Health Undersecretary Maria Rosario Vergeire said this is still their stand especially after the reevaluation conducted by a group of experts composed of medical societies, including the DOH and FDA.

"This is a conditional recommendation from them (against its use) because of the very low quality of evidence found across the globe," she said.

However, Agbayani called this untrue, saying at least 50 studies have been done globally suggesting ivermectin's efficacy in the prevention and early treatment of COVID-19.

"'Yung mga nakakausap natin sa gobyerno para bang nagbubulag-bulagan eh [The government officials we have talked to seem like they're deliberately ignoring these research]," he said. "Imagine that. There are 50+ studies, and they keep saying na wala or kaunting-kaunti [there is none or very little available].

Agbayani said he believes they're "making a difference" and that the drug will help make COVID-19 cases in the country more manageable.

Besides the DOH and FDA, other health experts, including from the World Health Organization, have cautioned the public against the use of ivermectin for COVID-19 prevention or treatment. According to Vergeire, there are also suggestions against the use of ivermectin for severe COVID-19 patients. Experts have also warned high doses of ivermectin could cause brain damage in humans, or even death.

CNN Philippines correspondent Xianne Arcangel and Carolyn Bonquin contributed to this report.