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Ivermectin still not for distribution despite compassionate use permit, says Domingo


Distribution of anti-parasitic drug ivermectin as part of treatment for COVID-19 is still prohibited despite the Food and Drug Administration’s (FDA) approval of a hospital's application for compassionate use permit, FDA Director General Eric Domingo said Thursday.

In an interview on Super Radyo dzBB, Domingo said only the hospital that has the permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

"Yung ospital ang bibili, meron siyang licensed importer na magi-import para sa kaniya nitong gamot na ito na rehistrado sa ibang bansa," he said.

(The hospital will be the one to purchase the drug, which is registered in other countries, through a licensed importer.)

He explained that doctors who asked for this compassionate use permit will be obliged to list down the patients who will be taking ivermectin and report its effects to the FDA.

"The doctor takes full responsibility for the product," Domingo said.

During the day's Laging Handa briefing, Domingo said a hospital's request for compassionate use permit for ivermectin — an investigational product against COVID-19 — has been granted.

In the Philippines, the only registered ivermectin with the FDA is the one being used for animals.

Domingo has earlier said that a compassionate use permit is different from the pending application of two local manufacturers seeking for certificate of product registration for ivermectin.

A compassionate use permit only allows legal administration of the drug in the country but is not an endorsement of its safety and efficacy from the FDA.

A certificate of product registration, on the other hand, will allow manufacturers to sell the drug commercially and is an FDA guarantee that the drug is safe and effective.

Several lawmakers and physicians are pushing for the use of ivermectin to treat COVID-19 despite lack of scientific evidence and data that will prove its efficacy and safety.

Health experts warned that there is lack of evidence to prove that the drug can be a remedy for patients infected with COVID-19 despite articles and social media posts promoting Ivermectin as an anti-COVID-19 drug in Brazil, France, South Africa and South Korea.

The World Health Organization (WHO), the US FDA (Food & Drug Administration), European Medicine Agency (EMA), and even ivermectin manufacturer, Merck, all said there is lack of data and evidence of the efficacy and benefits for COVID-19 prevention and treatment. —KBK, GMA News

Tags: ivermectin, news