MANILA – The Food and Drug Administration (FDA) may be held liable for granting a hospital’s request for a compassionate special permit (CSP) to use Ivermectin against coronavirus disease 2019 (COVID-19), former Department of Health (DOH) secretary and now Iloilo Representative Janette Garin said.
According to her, most of the prerequisites for the Ivermectin CSP application “have not been complied with.”
She mentioned the Administrative Order No. 4 series of 1992 issued by the late DOH secretary Juan Flavier. She said that a CSP can be issued to a specialized institution or a specialty society even for an “investigational product” provided the requested product must have ongoing phase three clinical trials in its country of origin or other countries, or there is an ongoing clinical trial in the Philippines but the enrolment of a patient in the trial is not possible.
The other one is that, the product is in the process of applying for market authorization in the country of origin or in the Philippines.
“It’s very clear in the guidelines – the issuance of CSP for Ivermectin is way beyond what is bound in that. You cannot just give outright permits without consulting the experts,” Garin told CNN Philippines’ The Source on Friday.
On Thursday, FDA Director General Eric Domingo announced that a request of an unnamed hospital for a CSP to use the anti-parasitic drug against COVID-19 has been granted.
According to Garin, FDA seemed to be “pressured” and “bullied” to approve the limited use of Ivermectin despite previous warnings that there is no sufficient data that it can cure or prevent COVID-19.
“Pardon me for this, but the FDA is allowing itself to be bullied,” Garin said. “And that’s a very scary thing. Because the very institution that should be independent is now submitting itself to the outside pressures of the world.”/PN
