Hospital granted a special permit to use Ivermectin ‘eligible’ to secure FDA approval — Domingo

Published April 9, 2021, 5:51 PM

by Ellalyn De Vera-Ruiz

Food and Drug Administration (FDA) Director General Eric Domingo said the agency has granted the “compassionate use” of Ivermectin to a certain hospital because it was “eligible” and has passed the requirements.

(JANSEN ROMERO / FILE PHOTO / MANILA BULLETIN)

“Hindi naman namin bibigyan ng CSP [compassionate special permit] kung hindi eligible [yung hospital]. (We will not issue a CSP if the hospital is not eligible,” Domingo said in a Department of Health briefing on Friday, April 9.

“Kaya po sya nabigyan ng CSP dahil nag apply po yung isang ospital at nasubmit naman niya lahat ng requirements na kinakailangan. (That’s why it was given a CSP because the hospital applied and it submitted all the requirements),” he added.

Domingo explained that a doctor or hospital can request for a compassionate special permit (CSP) if a drug is not available in the Philippines but is registered and available in another country, or that a drug is undergoing clinical trial as a treatment for certain illnesses, such as coronavirus disease (COVID-19).

“Basta may ongoing clinical trial na Phase 3 sa ibang bansa. Ibig sabihin dumaan naman ito sa pagsusulit at ethics boards ng mga unibersidad saka ng mga research groups at technical experts at nakita nila na pwede itong pag aralan at imbestigahin kontra sa COVID-19 then enough yun para mag qualify sa CSP dito sa atin. (As long as there is an ongoing Phase 3 clinical trial abroad. This means that it passed testing and ethics boards of universities, as well as research groups and technical experts and they, saw that it can be studied and investigated against COVID-19 then that is enough to qualify for the CSP here),” he said.

He clarified that CSP is not a registration nor a marketing authorization.

“In fact walang garantiya ang FDA dun sa quality at efficacy ng gamot lalo na kung nasa clinical trial drug pa (the FDA has no guarantee on the quality and efficacy of the drug, especially if the drug is still undergoing clinical trial),” he said.

“Pero kapag ang doctor ay nanghingi ng (But when the doctor requests for a) CSP, they will take upon themselves complete responsibility over the product,” he added.

“Noong una yan [CSP] para lang sa cancer, HIV/AIDS, and other life-threatening diseases. Pero since last year inexpand natin ang CSP to cover COVID-19 and other emerging infectious diseases kasi nakita nga natin na ang daming gamot na developed sa ibang bansa pero hindi available sa atin. (At first, CSP was only for cancer, HIV/AIDS, and other life-threatening diseases. But since last year we have expanded the CSP to cover COVID-19 and other emerging infectious diseases because we have seen many drugs developed in other countries but not available here),” Domingo said.

On why the FDA did not disclose the name of the hospital that was granted CSP for Ivermectin, Domingo said it was for patient privacy. 

“May privacy ang ating mga pasyente. Ayaw natin hanapin at dumugin sila. (Our patients have privacy. We do not want the public to look for them and besiege them). It’s really for patient privacy,” he said.

 
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