FDA grants a hospital compassionate special permit for Ivermectin use to counter COVID-19
The Food and Drug Administration (FDA) granted a compassionate special permit to a hospital for the use of anti-parasitic drug Ivermectin to treat COVID-19, according to FDA director general Eric Domingo Thursday.
Ivermectin is an anti-parasitic drug, which is intended for use on animals.
“Meron na po kaming na-grant dahil nga po ang Ivermectin ay isang investigational product,” Domingo said in a press briefing.
He added, “Alam naman natin may mga clinical trials ongoing dito para gamitin against COVID-19 so ang pagkaka-alam ko po, may isang ospital sa amin na nag-apply ng compassionate special permit for the use of Ivermectin at ito po ay na-grant ngayong araw na ito.”
Being granted the compassionate special permit, the FDA does not guarantee that the product is effective and safe to use. Ivermectin is not approved to treat any viral infection, according to the FDA.
The permit was granted to the hospital, which Domingo did not name “out of patient privacy,” despite the stance of FDA and the Department of Health against the use of Ivermectin to combat COVID-19.
With FDA’s move, some expressed confusion as in an earlier statement, the regulator warned the public to avoid any use of Ivermectin veterinary products to treat COVID-19 because its benefits and safety for this purpose are yet to be established.
Iloilo Rep. and former Health Secretary Janette Garin called out the FDA for its decision.
“FDA’s action is presumed to be political rather than medical. This should not have a place in an institution who is primarily responsible for safety and efficacy of drugs and vaccines prior to allowing Filipinos to access such,” Garin said in a statement.
She continued, “Compassionate use means access is a potential pathway for a patient with an immediate and urgent life-threatening condition or serious disease when no other option is available. Therefore, you give it to dying patients where risks of an experimental drug are outweighed by current situation of the patient. Kumbaga, no choice na. Last resort.”
Garin also stressed that decisions made by the FDA should always be backed by science as it is dealing with public health.
“Anti-parasitic drug na gamot sa hayop ginawang anti-viral na gamot sa tao? Para nilang sinabing pareho lang ang langgam sa daga. Pinareho nila ang galising aso o pusa sa mga may COVID-19,” she said.
Meanwhile, the World Health Organization recently said the current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive and that the parasitic drug be used within clinical trials only.