A lawmaker swore to fight the Food and Drug Administration (FDA) in court if it blocks his plan to distribute the antiparasitic drug ivermectin for free.
Inspired by the community pantry of Quezon City, Anakalusugan Party-list Rep. Mike Defensor and House Deputy Speaker Rodante Marcoleta will be holding an “Ivermectin Pan-three”. They will give away three capsules of the drug per beneficiary for free.
Individuals can have the ivermectin by showing their medical prescriptions. The doctors at the site can also prescribe it based on their medical information. The drugs will be made by a licensed compounding laboratory, Defensor said.
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. Defensor said that no less that FDA Director Eric Domingo himself said this in a recent Congressional hearing. The party-list lawmaker said they will not be violating any law with a no-cost distribution because it still complies with FDA regulations.
“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. On two occasions during the hearings, sinabi nila na ito ay pupwedeng proseso,” he said.
As long as a doctor will check those in line before issuing a prescription, the FDA chief has no objection to the planned ivermectin pantry.
Domingo, however, stressed that the doctor giving the prescription will be the one held responsible for possible adverse side effects experienced by the patient 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 stated in a separate interview.
Only the five hospitals granted with compassionate special permit by the FDA can “legally” dispense ivermectin, the Health Department said. But Domingo argued that 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.
If the compounded ivermectin was made by a licensed pharmacy and then prescribed by the doctor then that is “legal,” he stated.
“The FDA is not for or against any medicine. Ang bawal lang sa amin ay unregulated at unregistered,” Domingo added.
Dr. Iggy Agbayani of the Concerned Doctors and Citizens of the Philippines said that they will regularly monitor the effect of the drug on the recipients. An estimated 100,000 people will receive ivermectin over the next few weeks, he added.
“We are doing a clinical trial, pero hindi siya part of any big scheme to wait for,” he noted. “Like any group of doctors, we want to know kung may impact ‘yung gagawin”.
The possible adverse effects from the drug would be: allergy, nausea, or diarrhea, but Agbayani noted that these are normal. Recipients will have to register and report their health condition online or through their barangay officials, Agbayani added.
Ivermectin still has no concrete evidence to be effective in treating mild to moderate Covid-19 infection, DOH insisted.
Health Undersecretary Maria Rosario Vergeire said that this is still their stance 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, 50 studies were conducted globally suggesting ivermectin’s efficacy in the prevention and early cure of Covid-19, he added.
“‘Yung mga nakakausap natin sa gobyerno para bang nagbubulag-bulagan eh”, he said. “Imagine, there are 50+ studies, and they keep saying na wala or kaunting-kaunti”, he added.
Agbayani believes that they’re “making a difference” and Covid-19 cases in the country will be more controllable with the help of the drug. Ronald dela Cruz