The Food and Drug Administration (FDA) has granted a third hospital the permit to use anti-parasitic drug ivermectin for COVID-19 patients.
FDA director-general Eric Domingo disclosed on Thursday, April 22, that the regulatory agency issued on Wednesday a compassionate special permit (CSP) to another hospital. Three hospitals have CSPs for ivermectin so far.
“Mayroon pa pong na-approve na isang hospital kahapon (An application of another hospital was approved yesterday),” Domingo said.
“May pending pa po na isa na nag-apply din kahapon na may kulang lang na papel na isa-submit (Another hospital has also applied yesterday but it has yet to submit a lacking document),” he said.
CSPs are issued to allow expedited access to drugs that are being investigated for certain use. The permit allows the administration of drugs for urgent, life-threatening conditions or serious diseases, but with permission from the patient.
Doctors or hospitals must also submit proof of ongoing clinical trial date from other countries and must justify that there is no existing superior of alternative therapy that can adequately control the condition of the patient.
The FDA had clarified, however, that CSPs do not equate to a certificate of product registration (CPR), which allows the sale of the drugs in the market.
The FDA and the Department of Health (DOH) have repeatedly said that they do not recommend ivermectin for the treatment of COVID-19 yet due to lack of strong evidence of its efficacy.
Domingo reiterated to lawmakers that they are not anti-ivermectin, but are only against the distribution of unregistered drugs to the public.
The FDA has granted a total 1,951 CSPs for investigational COVID-19 drugs, including not only ivemectin, but also remdesivir, fapiravir, and most recently leronlimab, he said.