FDA to Garin: Hospital got ivermectin permit upon application
MANILA, Philippines — The Food and Drug Administration (FDA) said Friday that the hospital that was granted a compassionate special permit (CSP) to use ivermectin for COVID-19 patients received such approval after submitting a proper application.
FDA Director General Eric Domingo said this in response to former Health Secretary and Iloilo Rep. Janette Garin’s comment that the issuance of CSP to an unnamed hospital “seems [more like] a political accommodation than a medical decision.”
READ: Ex-health chief on permit to use ivermectin: ‘Political accommodation’
“Hindi naman namin siya bibigyan ng compassional special permit kung hindi siya eligible. Like I said, ‘yung eligibility dito are drugs that are registered in another country and are not available here for COVID-19, or clinical trial drugs,” Domingo said in an online press briefing.
(It will not be given a compassionate special permit if the drug was not eligible for it. Like I said, eligibility for this permit is for drugs registered in another country and are not available here for COVID-19 treatment, or clinical trial drugs.)
“Kaya po siya nabigyan ng CSP dahil nag-apply po ‘yung isang hospital at nasubmit naman po niya lahat ng requirements na kinakailangan (The hospital was given CSP because it submitted all the requirements),” he added.
Garin said on Thursday that the FDA’s action is “presumed to be political [in nature] 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,” she said.
She added that “issuing a compassionate use permit for just one hospital but saying it cannot be distributed and used for COVID-19 treatment in general seems to be more of a political accommodation than a medical decision.”
“Isang malaking joke (It is a big joke),” Garin added.
The lawmaker made the remark following Domingo’s announcement that the FDA had released a CSP for a hospital’s use of ivermectin for COVID-19 patients. He noted that ivermectin is an “investigational product” and that clinical trials on its use for COVID-19 are currently ongoing.
READ: FDA lets hospital use ivermectin for COVID-19
However, Domingo declined to disclose the hospital’s name that had applied for the CSP, citing patient privacy.
An application for a certificate of product registration for human use of ivermectin filed by Lloyd Laboratories Inc. is now pending before the FDA.
READ: Local firm applies for registration of Ivermectin for human use
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