FDA: No power vs. solons giving out ivermectin

Food and Drug Administration (FDA) Director-General Eric Domingo said Wednesday the agency had no disciplinary authority, only Congress, over lawmakers who distributed ivermectin, despite the lack of evidence that the anti-parasitic drug could treat patients with COVID-19.

“Yes. It’s a separate branch of government,” Domingo said at the Kapihan sa Manila Bay forum when told that only Congress had the power to impose sanctions on its members.

Anakalusugan party-list Rep. Mike Defensor and Deputy Speaker Rodante Marcoleta distributed ivermectin despite repeated warnings from health authorities and groups that it has not been proven to be effective against coronavirus that causes COVID-19.

Defensor said a house-to-house distribution of ivermectin would also be done to prevent mass gathering.

Domingo cited the need to determine if there were laws and regulations violated, when asked about  the distribution plan of the Congressmen.

“There are legal ways of treating a patient, but you have to prescribe properly and the medicine has to be dispensed properly. And the patient has to be made aware what the medicine is and what the possible effects are,” he said.

“Medicine is very apolitical and treatment of patients should be very scientifically based and based on evidence,” he said.

Meanwhile, the FDA is investigating reports that doctors wrote prescriptions on blank pieces of paper instead of on prescription pads under the distribution project of Defensor and Marcoleta, Domingo said.

“Our enforcement unit has been investigating since this weekend and I’m waiting for their report,” Domingo said.

Meanwhile, medical groups joined Wednesday the growing chorus of warnings against using antiparasitic drug ivermectin as a COVID-19 treatment, stressing there is not enough evidence that it helps against the novel coronavirus disease.

In a joint statement, members of the Healthcare Professionals Alliance Against COVID-19 said claims by supporters that ivermectin was effective and safe from side effects remain based on "low quality evidence."

"Let us not patronize yet the ivermectin to prevent further risk to our health," HPAAC said in Filipino. "We also remind the public that it is not certain whether ivermectin available now is fake or effective due to its violations of FDA's regulatory processes."

HPAAC supported the Philippine Pharmacists Association's call for health authorities to investigate doctors who prescribed the drug at a distribution to residents in Quezon City.

The event was organized by Rep. Mike Defensor (Anakalusugan party-list) and Rep. Rodante Marcoleta (SAGIP party-list) against the Department of Health and the Food and Drug Administration's warnings.

"If found liable, we call on the Professional Regulation Commission to investigate and hold accountable those who violated the law," it added.

Meanwhile, six hospitals so far have secured a compassionate special permit for the use of the antiparasitic drug ivermectin on COVID-19 patients, FDA Director General Domingo said Wednesday.

“I don’t have the list with me right now. They are private hospitals, not only in Metro Manila. That means the doctors in the hospital can prescribe it,” Domingo said during the Kapihan sa Manila Bay forum.

“We don’t want to violate the privacy of the patients. Of course, the hospitals can freely identify themselves. We’re not stopping them,”said  Domingo, when asked why the FDA would not release the names of hospitals.

Domingo had earlier said that a CSP was not a marketing authorization.

He said that  ivermectin could not be sold commercially yet.

The World Health Organization and the European Medicines Agency still do not recommend ivermectin for COVID-19 cases outside controlled clinical trials.

Ivermectin maker Merck said in February that there was “no scientific basis for a potential therapeutic effect” based on preclinical studies.

The Philippines is expected to begin the clinical trials of ivermectin later this month.

At the same time, several groups of doctors have urged authorities to prioritize COVID-19 vaccination as against the intake of prophylaxis such as ivermectin, an infectious disease expert said Wednesday.

Several doctors organizations have warned their members against prescribing the anti-parasitic drug without compassionate special permit.

Dr. Rontgene Solante, head of adult infectious diseases department at San Lazaro Hospital, said among these was the Philippine College of Physicians.