Sotto welcomes FDA approval of Ivermectin sale, distribution

Published May 8, 2021, 11:45 AM

by Vanne Elaine Terrazola

Senate President Vicente Sotto III welcomed the Food and Drug Administration’s (FDA) grant of a certificate of product registration (CPR) allowing the local manufacture and distribution of anti-parasitic drug ivermectin for human intake.

Senate President Vicente ‘Tito’ Sotto III

“It removes the claim of some that the drug is illegal,” Sotto said in message to the Manila Bulletin on Saturday, May 8.

FDA director-general Eric Domingo, however, clarified that the CPR issued to a pharmaceutical firm classifies ivermectin as an “anti-nematode drug”, or for expelling parasitic worms.

He did not mention its approval for treating or preventing novel coronavirus disease (COVID-19).

Some lawmakers and doctors have strongly advocated for the use of ivermectin against COVID-19 despite the lack of medical studies proving its efficacy and safety. At present, ivermectin is widely used as an animal drug, and has only been registered as a topical medication for humans with external parasites.

The FDA has yet to grant an emergency use authority for ivermectin, but six hospitals have so far been allowed to use the experimental drug for COVID-19 patients.

But the grant of the CPR essentially allows the sale of ivermectin to the market, as prescribed by physicians in specific doses.

Because of this, Sotto said he does not anymore see the need to call for a Senate inquiry on the FDA’s supposed refusal to act calls for the widespread use of ivermectin.

He maintained that people should be allowed access to the medicine.

“As long as they do not consider it an illegal drug like what some people are saying, I’ll keep my peace,” he said in a separate message to reporters Friday night.

Sotto previously admitted to taking the anti-parasitic drug as a “protection” against the novel coronavirus.