FDA: 6 hospitals have secured special permit for ivermectin use vs COVID-19

Robie de Guzman   •   May 5, 2021   •   547

MANILA, Philippines — Another hospital has secured a compassionate special permit (CSP) for the use of ivermectin to treat patients with coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Wednesday.

FDA director-general Eric Domingo said there are now six hospitals within and outside Metro Manila that have been allowed limited use of the anti-parasitic drug on COVID-19 patients.

“That means the doctors in the hospitals can prescribe it [ivermectin],” he said in an online forum.

Domingo declined to identify these hospitals with CSP since the FDA doesn’t want to “violate the privacy of the patients.”

“Of course, the hospitals can freely identify themselves. We’re not stopping them,” he added.

The FDA earlier said that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

Only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

Doctors who will prescribe the drug to treat COVID-19 patients are required to report to the FDA on a monthly basis. They will also be held liable for possible side effects.

The FDA also reiterated that a compassionate use permit is different from a certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

Domingo likewise stressed that the drug is still an investigational product and is not yet approved as COVID-19 treatment in the country.

The clinical trial for ivermectin as possible COVID-19 treatment is expected to start in May or June.

Aplikasyon para sa 2 brand ng COVID-19 self-test kits, pinoproseso na – FDA

Robie de Guzman   •   January 11, 2022

MANILA, Philippines – Sinisimulan na ng Food and Drug Administration (FDA) ang pagproseso sa aplikasyon ng dalawang brand ng COVID-19 self-test kits.

Ayon kay FDA director general Oscar Guiterrez, sinusuri na ng ahensiya ang mga aplikasyon para sa paglalabas ng special certification

“Dalawa po ang ini-evaluate ng FDA sa ngayon. Na-endorse na po ito kahapon sa RITM para sa technical validation. Once matapos po ng RITM, pwede na po mabigyan ng FDA ng special certification,” ani Gutierrez.

Habang wala pang aprubadong COVID-19 home test kits sa bansa, nagpaalala ang Department of Trade and Industry (DTI) sa publiko na mag-ingat sa mga ibinibentang COVID-19 home test kits online.

Ayon kay DTI Assistant Secretary Ann Claire Cabochan, hindi dapat tangkilikin ang mga ‘di rehistradong self-administered tesing kits dahil hindi tiyak kung ligtas itong gamitin o kung dumaan sa pagsusuri ng mga eksperto.

“Doon sa mga self-test kits na alam ko din na naging very in demand as of this time, of course, that has not been given the proper certification from the Food and Drug Administration to be sold here in the Philippines kaya hindi siya talaga dapat ibinebenta,” ani Cabochan.

Babala ng opisyal, maaaring maharap sa reklamo ang sinomang nagbebenta ng hindi rehistradong self-test kits sa bansa.

pwede nating habulin yung mga nagbebenta n’yan online for as long as this is not certified as legitimate to be sold in the Philippines,” ani Cabochan. (mula sa ulat ni Correspondent Joan Nano)

PH FDA says application for certification of self-administered COVID test kits now open

Robie de Guzman   •   January 7, 2022

MANILA, Philippines – The Food and Drug Administration (FDA) announced it has opened the applications for the certification of home test kits for COVID-19 amid the demand for testing due to the growing infection rate.

“I am calling po all the manufacturers and even the importers of self-administered COVID-19 test kits that — to register their product in a form of special certification,” Dr. Oscar Gutierrez Jr., FDA OIC director general, said during President Rodrigo Duterte’s Talk to the People on Thursday.

Gutierrez said they have already met with the Department of Health (DOH) for the issuance of the guidelines on the use of these self-administered kits and how people who use them can report the results.

 “We already met with the DOH and they will be coming out with an algorithm actually a guideline or policy on the use of these home test kits considering that these products need to be administered by the patient or the household themselves,” he said.

“Kailangan po natin ng guidelines on the use, reporting system, even disposal of the waste, interpretation of the test results, and what actions should the individual take when he finds out that he is positive,” he added.

Gutierrez said self-administered test kits will get samples from individuals orally or through the mouth, and nasally or through the nose.

All the antigen test kits currently approved by the FDA are only administered by laboratories and healthcare professionals.

The DOH earlier reiterated the proper use of antigen test kits at the right time for more accurate test results. The agency said antigen test is better used to check symptomatic persons for COVID-19 infection.

Domingo resigns as FDA chief

Maris Federez   •   January 3, 2022


MANILA, Philippines — Dr. Eric Domingo on Monday confirmed his resignation as director-general of the Food and Drug Administration (FDA) effective January 3, 2022.

In a text message to reporters, Domingo said he is resigning as “he already did his part during the pandemic”.

“The FDA is now stronger, more efficient and systems are in place. It’s time for me to move on to other things,” he added.

The Department of Health (DOH), in a statement, also confirmed Domingo’s resignation, adding that FDA deputy director-general Dr. Oscar Guiterrez has been appointed as the department’s officer-in-charge, replacing Domingo.

“Yes. We confirm the resignation of FDA Director-General Eric Domingo. Dr. Oscar Gutierrez, Deputy Director-General, FDA, was assigned as OIC,” the statement read.

Domingo was first appointed as OIC of the FDA in May 2019.

President Rodrigo Duterte appointed him as director-general in February 2020. —/mbmf


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