FDA says it can grant ‘compassionate’ permit for Ivermectin use vs. COVID
CNN – Published Mar 29, 2021 2:12:17 PM
Metro Manila — The Food and Drug Administration on Monday said hospitals may apply for “compassionate special permit” to use Iverrmectin, an antiparasitic drug for animals, to treat COVID-19 patients.
“Eligible naman po for application for compassionate special permit ang Ivermectin. Kaya lang wala pa po kasing naga-apply,” FDA Director General Eric Domingo said during a virtual briefing.
[Translation: Ivermectin is eligible for a compassionate special permit application. However, no one has applied yet for its use.]
Health authorities issued warnings against the use of Ivermectin as treatment for COVID-19 as trials conducted in other countries did not show positive outcome. Ivermectin is a drug for parasite infestation such as head lice and scabies.
Domingo said they are cautious about the drug as it is only registered for animal use.
He said Ivermectin is an “investigational drug” and hospitals, including doctors, may apply for its CSP.
The FDA chief, however, said institutions or doctors would “take full responsibility” for the product.
“So kung gusto po ng kahit sino na doctor o hospital na gumamit ng isang gamot under compassionate special permit, then they have to apply po sa FDA at kailangan lang pong kumpleto ang requirements at of course, they take full responsibility for the products. So maaari po yun, basta sumunod lang po sa tamang proseso,” Domingo said.
[Translation: So if any doctor or hospital wants to use a drug under compassionate special permit, then they have to apply before the FDA and they just need to complete the requirements, and of course, they take full responsibility for the product. That’s it, just follow the right process.]
The House of Representatives will also hold a hearing to discuss the use of Ivermectin.
“We will take the opportunity para ma-explain natin kung ano ang regulatory process sa FDA at kung paano mapapasok nang legal at safe ang gamot,” Domingo said.
SOURCE: https://cnnphilippines.com/news/2021/3/29/fda-ivermectin-compassionate-permit.html?????
