Garin hits FDA’s special permit for Ivermectin use vs COVID-19

BY HANNAH TORREGOZA

Iloilo Rep. Janette Garin slammed on Monday the Food and Drug Administration (FDA) for justifying its decision to grant compassionate special permit (CSP) for the use of Ivermectin to treat COVID-19 patients.

The former secretary of Department of Health said hearing FDA Director General Eric Domingo vindicating its use implies possible “intellectual dishonesty.”

The lawmaker pointed out Domingo should identify the hospital that has conducted ongoing trials on the use of human-grade Ivermectin and show proof that it was reviewed and approved by the Center for Drug Regulation and Research.

“That is very fishy, I would say. It will take weeks for the Center for Drugs and its panel of experts to review the voluminous documents that goes with the task DG Domingo was referring to,” Garin said in a statement.

“God sees you, stand by your oath as a doctor. We are tired. We are angry. We are exhausted. It has been over a year and yet we are worse off. We want to get more vaccines. We want to find a cure,” she added.

“I understand the desperation of clinging onto and believing something, hoping that it is the cure we are looking for to stop this pandemic and keep our families safe. But let me be clear – that is not Ivermectin,” the former health secretary pointed out.

Domingo earlier said that while hospitals have been granted a CSP for using human-grade Ivermectin to treat COVID patients, it is up to the doctors to be responsible should there be possible side effects.

But Garin reiterated the Administrative Order 2020-0028 on the issuance of CSP is possible providing that a medicine should have undergone Phase 1 and Phase 2 clinical trials.

The AO also requires that a medicine granted a CSP should be part of Phase 3A clinical trials in other countries.

“If there is an ongoing trial, where is it? Is the Philippines even a part of it? Are we using the same source, dosage, preparation and indication?” she pointed out.

She also criticized Domingo’s refusal to disclose the name of the hospital that applied for CSP.

“This is absurd! While privacy of patients is being respected, transparency regarding the hospital is mandatory simply because it will be a guide for all practitioners to bring their patient to that center dealing/ licensed to import and use the product issued a CSP, considering that everything was above board,” she explained.

“If you issued a CSP for a product, it should be highly regulated. But why did the FDA granted a License to Operate to a company which could freely import Ivermectin? Bakit ka pa nag CSP?,” she asked.

Garin said she is disappointed that the FDA, an institution that should be protecting the Filipino public from harmful drugs, vaccines and other vaccines have succumbed to pressure.

“Unfortunately, the decision to issue a CSP to possibly succumb to outside pressure shows that the institution has forgotten its mission of guaranteeing the safety, quality, purity, efficacy of products in order to protect and promote the right to health of the general public,” she said.

“Let me be clear, I am not against Ivermectin but I am against using it as a treatment for COVID-19 until there is enough proof to show its efficacy and effectiveness,” she reiterated.

“Let us not place our faith in a product which has not been scientifically proven to cure or prevent COVID-19,” the solon appealed.