Ivermectin granted special permit by FDA

    367

    THE Food and Drug Administration (FDA) yesterday issued a compassionate special permit (CSP) for the use of Ivermectin to treat coronavirus disease (COVID-19) patients.

    Ivermectin is a drug used for parasite infestations in humans and animals.

    The special permit allows limited use of investigational drugs or unregistered drugs.

    The FDA announcement came amid persistent calls from some sectors, including a lawmaker, to allow the use of the drug for COVID patients.

    Late last month, the World Health Organization issued a statement against the use of Ivermectin for COVID-19 patients except for clinical trials, because of a lack of data demonstrating its benefits.

    Also last month, the FDA said Ivermectin is eligible for special use permit, but no hospital has applied for a permit.

    FDA Director General Eric Domingo yesterday said the CSP was granted to a hospital which he declined to identify, citing “patient privacy.”

    Domingo also said there are also two pending applications for certificate of product registration (CPR) for Ivermectin products for humans.

    Currently, Ivermectin products that are registered for human use are “for the treatment of external parasites such as head lice and skin conditions.”

    “We already gave them the list of requirements for their applications to begin rolling and be evaluated,” said Domingo.

    One of the applicants for CPR is Lloyd Laboratories.

    A CPR is a document issued by the FDA for products that have been approved and registered in the Philippines.

    According to Domingo, the processing of CSP and CPR applications only proves that the FDA is not against Ivermectin.

    “For us, they just need to get the product registered, go through the process that will ensure the safety and quality of the product,” he said.

    The Department of Health on Wednesday warned against unauthorized distribution of Ivermectin, following the pronouncement of Rep. Mike Defensor (PL, AnaKalusugan) that he will be providing Ivermectin to residents of Quezon City for free.