FDA grants a hospital compassionate special permit for ivermectin use
MANILA, Philippines — The Food and Drug Administration (FDA) on Thursday granted a hospital a compassionate special permit for the use of anti-parasitic drug ivermectin to counter COVID-19, FDA Director-General Eric Domingo said.
“Meron na po kaming na-grant dahil nga po ang ivermectin ay isang investigational product,” Domingo said in a televised briefing when asked if the FDA has granted a compassionate special permit for the drug’s use.
(We have granted this, given that ivermectin is an investigational product.)
“Alam naman nating may mga clinical trials ongoing dito para gamitin against COVID-19 so ang pagkakaalam ko po, may isang ospital sa amin nag-apply ng compassionate special permit for the use of ivermectin at ito po ay na-grant na ngayong araw na ito,” he added.
(We know there are ongoing clinical trials for this to be used against COVID-19. A hospital applied for a compassionate special permit for the use of ivermectin and it was granted today.)
When asked which hospital was granted the compassionate special permit, Domingo told INQUIRER.net he can’t say “out of patient privacy.”
“Yes, for COVID-19. The doctor is responsible for the use of the drug,” he said when asked if the issuance of the permit was for COVID-19 care.
A compassionate special permit allows for the limited use of investigational drugs or unregistered drugs.
The compassionate special permit was granted even as both the Department of Health and the FDA said they do not recommend the use of ivermectin for COVID-19 care as existing evidence does not support such claims.
The World Health Organization is also not advocating the use of ivermectin in the absence of statistically relevant evidence of its effectiveness against COVID-19.
Meanwhile, Domingo added that there are now two applications before the FDA for a certificate product registration (CPR) of ivermectin for human use.
“So binigay na rin po sila ng listahan ng mga requirements na kailangang isubmit para po umandar ang kanilang application at ma-evaluate,” he said.
READ: Local firm applies for registration of ivermectin for human use
In the Philippines, all current ivermectin products registered are only for veterinary use to treat external parasites and prevent heartworm disease in animals.
EDV/MUF
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