FDA rules on ivermectin could set precedent for other COVID 'cures': lawmaker


Posted at May 07 2021 11:12 AM | Updated as of May 07 2021 11:26 AM

MANILA - The Food and Drug Administration should be firm in its guidelines on anti-parasitic drug ivermectin, saying its decision could set a precedent for other drugs that claim to be a cure for COVID-19, the chairperson of the health committee at the House of Representatives said Friday.

"I think may confusion when it comes to implementation, that’s why I asked the enforcement agencies natin like FDA and DOH (Department of Health) to be firm on their stand and to clarify talaga alin lang ang puwede at alin ang hindi (what are allowed, what are not)," Rep. Helen Tan, a doctor who chairs the House Committee on Health, told ANC's Headstart.

"Kasi kung pinayagan lang nila dahil na-sway ba sila dahil it’s a politician or dahil nagkaroon ng pagdinig sa Kongreso, mawawalan ng tiwala ang mga mamamayan kung ganun," she said.

(If they allowed it because they were swayed becauase it's a politician or because there was a Congress hearing, people will lose their trust.)

The FDA has granted compassionate use permits to at least 6 hospitals that wish to use human-grade ivermectin on COVID-19 patients. Last month, Reps. Mike Defensor and Rodante Marcoleta distributed this drug to people who were reportedly given prescriptions by on-site doctors.

Tan said she spoke with FDA Director General Eric Domingo before her colleagues distributed ivermectin, and the official said this was allowed.

"Nilinaw ko sa kanya kung ito ba ay pinapayagan kasi we have 5 hospitals, whom issued the compassionate use. He said, yes, allowed 'yun kung 'yung kanilang katuwang doon sa ginawa nila ay licensed compounding facility," she said.

(I clarified with him if this is allowed because we have 5 hospitals who were issued the compassionate use. He said, yes, it is allowed if their partner is a licensed compounding facility.)

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The FDA has said it cannot punish the 2 lawmakers as its mandate is limited to investigating only the drug manufacturer, the distributor and the pharmacy that dispensed the drug.

Domingo also said while the FDA does not encourage the prescription of drugs as off-label, this is not illegal "as long as you explain it to the patient." 

Tan, however, pointed out that this is usually done when the doctor is familiar with the patient's condition, and a simple interview is not enough.

She said she does not want to say her committee will sanction Defensor and Marcoleta over the distribution, but said a hearing can be a "good venue" to discuss what are the correct guidelines.

The House Committee on Health is set to have its hearing in the second or third week of May, she said.


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