FDA chief denies pressure in allowing compassionate use of ivermectin
TO USE OR NOT TO USE A number of physicians swear by the effectiveness of Ivermectin, an antiparasitic drug commercially available only for veterinary use, as a treatment or preventive
medicine against COVID-19. But the Food and Drug Administration maintains there are procedures to be followed, including clinical trials, before the drug could be allowed for distribution. —AFP
MANILA, Philippines — The Food and Drug Administration (FDA) did not succumb to pressure when it decided to grant compassionate special permit (CSP) to two hospitals for the human use of ivermectin to fight COVID-19, Director-General Eric Domingo said Friday.
Interviewed in INQUIRER.net’s INQside Look, Domingo denied that the FDA’s decision to grant a CSP was due to pressure, saying they only followed their protocol and regulations.
“Our rules and regulations have been there since last year for the CSPs for anti-COVID-19 medicine. Dito kasi, may checklist ka naman. Kapag nag-apply, isa-submit mo. Pag pumasa, bibigyan ka ng permit,” Domingo said.
“Hindi naman pressure yun. Ibig sabihin, naka-comply sila sa requirements,” he added.
Pressed if he is saying that the FDA did not succumb to pressure by ivermectin advocates, Domingo said: “Yes. That’s the only way to do your job.”
Article continues after this advertisement“We can never please everybody. Laging, pag nag-approve ka, mayroong galit sayo, pag hindi ka nag-approve mayroong galit sayo,” Domingo said.
Article continues after this advertisement“Pero ang magagawa mo lang ay sundan mo yung tamang proseso and if you do your job as it is written, as it is supposed to be done, then you make sure that you are fair to everybody and that fairness is something that the FDA can guarantee,” he added.
According to Domingo, while those against ivermectin have slammed the FDA for supposedly succumbing to pressure, its advocates have also hit the agency for being too strict with its regulations.
“All I have to say is, first of all, we are not anti-ivermectin but we are anti-unregulated ivermectin. We are anti-illegal drugs. Hindi pwede yung unregistered. Hindi pwede yung veterinary ire-reseta sa tao,” Domingo said.
“Hindi kami namimili dito ng sides kasi talagang yung trabaho lang namin is to make sure the safety at quality at efficacy ng gamot na available sa inyong lahat,” he added.
Both the Department of Health (DOH) and the FDA had repeatedly said that there is no registered ivermectin drug in the country for human consumption, while no less than the World Health Organization (WHO) said that there is not enough data to say that the drug can be used for COVID-19.
Nonetheless, the FDA has so far granted two hospitals a CSP for the use of ivermectin to counter COVID-19. The FDA, however, stressed that ivermectin can only be prescribed by doctors in those hospitals that has managed to secure CSPs.
Domingo explained that CSPs are issued when doctors want to seek permission to use a drug that is not registered and not available in the Philippines. These drugs, however, have to be a “proven drug or an investigational drug” in other countries.
Doctors also accept accountability should there be issues with the drug they prescribed, he said.
