Duterte orders FDA to deal with illegal sale, distribution of ivermectin

Robie de Guzman   •   April 21, 2021   •   285

MANILA, Philippines – President Rodrigo Duterte has directed the Food and Drug Administration (FDA) to take the lead in dealing with illegal traders of anti-parasitic drug ivermectin amid push to use this to treat COVID-19, Malacañang said Wednesday.

“To ensure the safety and welfare of the public and at the same time avoid any unnecessary conflicts, the Food and Drug Administration (FDA) has been directed to take the lead in determining the course of action against the illegal trading/dispensing of Ivermectin,” Presidential Spokesperson Harry Roque said in a statement.

“The Philippine National Police (PNP) cannot arbitrarily determine on their own which drug/s should not be on the market. All operations to apprehend or seize goods must be done in coordination with the FDA,” he added.

Roque, however, clarified that the FDA is only ordered to stop the sale or trade of ivermectin for veterinary use that has been repackaged as human grade, including those that have no been determined by competent authorities as safe to be used in humans.

“Having said this, we advise the public to seek the advice of medical practitioners before taking medicines and/or supplements,” he said.

“The President is closely monitoring the developments concerning ivermectin here and abroad. He has even directed the Presidential Management Staff (PMS) to give him weekly updates on ivermectin studies and FDA-related clearance,” he added.

The FDA earlier granted two hospitals compassionate special permit for ivermectin.

The agency, however, reiterated 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.

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

The FDA likewise stressed that 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 use ivermectin to treat COVID-19 patients are required to report to the FDA on a monthly basis.

The FDA also said that distribution and promotion of ivermectin as a COVID-19 treatment remains prohibited in the country.

Ivermectin is registered in the country for veterinary use to prevent heartworm disease and treat internal and external parasites in certain species.

Ivermectin products registered for human use in the country were in topical formulations under prescription use only.

Show-cause order issued to FDA drug center for alleged inaction on over 600 applications

Marje Pelayo   •   May 12, 2021

MANILA, Philippines – The Anti-Red Tape Authority (ARTA) has issued a show-cause order to the Food and Drug Administration (FDA) Center for Drug Regulation and Research (CDRR) for allegedly not acting on over 600 drug applications despite having complete requirements.

The order, sent on Tuesday (May 11) by ARTA Investigation Enforcement and Litigation Director Jedrek Ng, directs FDA-CDRR Director IV Jesusa Cirunay  to “explain why no administrative or criminal case should be filed” against her over delays in applications of various pharmaceutical companies filed as far back as 2014 or so.

“Pag titingnan po ito ang mga applications na ‘to di ito kumplikado. Ito yung mga aplikasyong for automatic renewal. Ito ay mga produkto na dati nang ginagamit at ngayon ay gusto lang i-register o yung iba naman ay low to no risk sa taumbayan,” ARTA director general Jeremiah Belgica said.

“Di namin maintidihan kung bakit ito ay naiipit at ito ay palagi na nangyayari diyan sa FDA particularly sa Center for Drugs. Ito ay mga aplikasyon na pwedeng aprubahan ng center director,” he added.

Cirunay is given seven working days from receipt of the order to conduct an inventory of all pending permit, license, clearance or application; immediately release all said applications which have been pending beyond the prescribed processing time.

Also, she is directed to submit to ARTA a compliance report with a list of all permits, licenses, clearances or applications issued pursuant to the show cause order.

If Cirunay fails to comply, ARTA will resort to the filing of formal charges against her in accordance with Republic Act No. 11032 or the Ease of Doing Business and Efficient Government Service Delivery law before the Office of the Ombudsman.

Belgica also urged Health Secretary Francisco Duque III and FDA Director General Eric Domingo to remove, if necessary, their erring officials and personnel.

Evaluation of EUA application for Sinopharm vax may be completed in less than 21 days – FDA

Robie de Guzman   •   May 11, 2021

MANILA, Philippines – The evaluation process for the Sinopharm COVID-19 vaccine will not take long before it can be granted an emergency use authorization (EUA) in the Philippines, the Food and Drug Administration (FDA) said Tuesday.

FDA director-general Eric Domingo said the Sinopharm vaccine has already been included in the emergency use listing (EUL) of the World Health Organization (WHO) and access to its documents, including inspection reports from the WHO will be faster.

“Useful yung kanyang Emergency Use Listing sa WHO kasi before this, wala pa siyang EUA from a stringent regulatory authority katulad ng mga USFDA ganyan or Europe, Japan… hindi pa siya listed sa mga iyon. Pero yung WHO na emergency use listing that’s equivalent to a stringent regulatory authority,” he said.

“Ang maganda sa WHO kasi very transparent ang documents nyan. Available din siya sa FDA. Lahat ng ni-review nila, maaari naming ma-access kaya hindi tayo masyado mahihirapan sa paghingi ng information,” he added.

The Department of Health (DOH) earlier said it has started the process of applying for EUA, pending documents about the vaccine product.

The FDA said the process may take less than 21 days once the DOH completes the application process.

“Kapag ganyan na merong WHO EUL, mas mapapabilis iyan. Nakakaya natin iyan usually less than 21 days,” Domingo said.

The FDA also echoed the DOH’s earlier statement that there are no irregularities with the government’s move to file an EUA for a Chinese-made vaccine since they also applied for the EUA of other COVID-19 vaccine brands, such as Sinovac, AstraZeneca, and Pfizer, in order for these vaccines to be delivered to the country.

“Talagang nasa batas and it’s a worldwide practice,” he said. “Based on WHO guidelines, posible naman na gobyerno gusto bumili ng bakuna na walang local manufacturer or representative dito. In those cases, the government itself can get EUA.”

“Hindi naman conflict yun dahil ang EUA ay hindi naman product registration o marketing authorization lang, talagang for emergency use lang ang mga bakuna,” he added. – RRD (with details from Correspondent Aiko Miguel)

Gordon open to idea of conducting ivermectin clinical trials in PRC facilities

Marje Pelayo   •   May 7, 2021

MANILA, Philippines – Philippine Red Cross (PRC) chairman Senator Richard Gordon said the organization welcomes the conduct of clinical trials in its isolation facilities.

“Basta papayag ang mga pasyente. Wala pa naman akong nalalaman na namatay sa ivermectin. Basta papayag sila at ang gobyerno natin ang mangangasiwa,” Gordon said during the Laging Handa briefing on Friday (May 7).

During President Rodrigo Duterte’s public briefing on Thursday (May 6), Department of Science and Technology (DOST) Secretary Fortunato dela Pena reported to the President that the government is eyeing the use of PRC facilities as venues for clinical trials particularly on the use of ivermectin.

Reacting to issues concerning the popular drug, the senator said he is not against the trial of ivermectin as it will help settle the controversies.

“Pagbigyan para matapos, para malaman natin once and for all,” he said. “I will say ‘no’ kung walang proper supervision, walang approval ng gobyerno.”

The DOST said the clinical trials on ivermectin will start in June.

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