FDA chief admits pressure over ivermectin okay

The Food and Drug Administration said Wednesday there had been some “pressure” to approve ivermectin as a drug for COVID-19 patients a week after it issued a compassionate use permit for the medicine.

But FDA Director General Eric Domingo stopped short of identifying the individuals, companies, or government agencies which exerted pressure for the FDA to approve the drug.

The permit allows doctors and hospitals to use the veterinary drug in certain cases even if the FDA has yet to approve its registration.

Meanwhile, the Philippine National Police has agreed to temporarily hold the implementation of its recent directive ordering the arrest of sellers and users of ivermectin, the anti-parasitic drug which is being repurposed for treatment of COVID-19, a House official said on Wednesday.

Thus said Deputy Speaker and Bagong Henerasyon Rep. Bernadette Herrera, as she reported the outcome of her fruitful teleconference with Senator Christopher Go, Executive Secretary Salvador Medialdea, Presidential Management Staff chief Ferdinand Cui Jr., PNP chief General Debold Sinas and FDA’s Domingo on Tuesday.

Domingo told state television channel PTV: “There is pressure from different camps but the FDA only approves a drug based on merit and as long as complete requirements have been submitted.”

Domingo did not mention which individuals, companies or government agencies have been pressuring the FDA to approve the drug.

During the teleconference organized by Go, Herrera said PMS head Cui was briefed about the issue on Ivermectin, and why authorized sellers and users of the drug should not be arrested.

“I was able to explain to the PMS head, as well as to the PNP chief that we should not arrest individuals who would want to purchase Ivermectin from authorized sellers because it is not an illegal drug in the first place,” Herrera said.

“Secretary Cui agreed and he promised that in the coming days, they will amend the memorandum,” she said, referring to a memo issued by the PMS seeking the help of the PNP’s Criminal Investigation and Detection Group to coordinate with the FDA in the conduct of police operations against sellers and users of Ivermectin.

“We stressed that there is a human-grade Ivermectin medication and we should make it available and accessible to the public,” she added.

Herrera has joined several lawmakers, doctors and business groups in pushing the use of Ivermectin for the prevention and treatment of COVID-19, citing several clinical trials abroad showing that the anti-parasitic drug could kill coronavirus in cell culture in as fast as 48 hours.

The party-list lawmaker assured that she would not tolerate the illegal distribution of Ivermectin, as she reminded the public to buy only from authorized sellers.

Herrera thanked and lauded Go for his swift action by immediately setting up the teleconference, which served as an opportunity for her to clarify the issue with the concerned government officials.

Meanwhile, Herrera expressed hope “the FDA would really take a closer look at Ivermectin as a potential cure for COVID-19.”

Herrera said the FDA should go beyond allowing compassionate use of Ivermectin against the deadly disease given the worsening COVID-19 situation in the country.

She said the FDA should not ignore “encouraging” results of clinical trials conducted in several countries, including Australia, Japan, and the United States.

“We hope the delay in the approval of Ivermectin as COVID-19 drug is not deliberate. We also hope the FDA will maintain objectivity and it will not be swayed by large pharmaceutical firms lobbying against Ivermectin,” Herrera said.

“We should uphold the right of Filipinos to choose a COVID-19 treatment that is safe, effective, and affordable,” she added.

Herrera had earlier said Ivermectin was way more cost-effective than other potential repurposed drugs, such as Remdesivir.

She noted that remdesivir, the current drug being used to treat COVID-19-infected patients, costs around P28,000 per vial and must be administered twice daily until such time the patient is discharged.

Ivermectin, on the other hand, costs only around P35, to be administered once daily for three days, which means one needs to spend only a little over P100 for the entire treatment.

Topics: Food and Drug Administration , ivermectin , COVID-19 , Eric Domingo
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