FDA, not against ivermectin; insists registration process should be followed

Aileen Cerrudo   •   April 8, 2021   •   372

MANILA, Philippines — The Food and Drug Administration (FDA) has clarified that the agency is not against anti-parasite drug ivermectin, but it insists that there should still be a process to be followed for registration.

FDA Director-General Eric Domingo, in a public briefing on Thursday (April 8), said the agency already approved one hospital a “compassionate use permit” for ivermectin as a treatment for the coronavirus disease (COVID-19).

Ito lang naman po ang laging sinasabi ng FDA, hindi po kami kontra sa ivermectin. Kailangan lang po na irehistro ang produkto at dumaan lamang po sa tamang proseso ng pagsiguro po ng quality ng gamot na makakarating sa tao (This is what the FDA always say, we are not against ivermectin. The products should first be registered and go through the right process to ensure the people will receive quality medicine),” he said.

Domingo added that the FDA received two applications for a certificate of product registration (CPR) of ivermectin for human use.

Binigay na rin po sila ng listahan ng mga requirements na kailangang isubmit para po umandar ang kanilang application at ma-evaluate (They were already given the list of requirements for submission for their application to push through and be up for evaluation),” he said.

The World Health Organization previously warned against the use of ivermectin and did not recommend it in treating COVID-19 patients due to lack of data. -AAC

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

Robie de Guzman   •   April 21, 2021

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.

FDA open to probe into alleged delays in EUA, CPR issuances to local drug manufacturers

Marje Pelayo   •   April 21, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) welcomes the intention of the members of the House of Representatives (HOR) to investigate the process on the issuance of permits for drugs specifically the ones that show potential in combatting coronavirus disease (COVID-19).

During the Laging Handa briefing on Tuesday (April 20) FDA Director-General Eric Domingo stated that the agency has a set of standards on issuing approval on applications for Certificate of Product Registration (CPR) and Emergency Use Authorization (EUA).

“Mayroon naman tayong set ng policies at mga standard na sinusunod bago mag-approve po ng isang gamot kasama na ang safety, quality, and evidence on efficacy,” Domingo said.

Domingo said the investigation will help the FDA explain the measures it applies in expediting the country’s access to medicines, diagnostic kits, and other medical needs.

This,  after House Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera-Dy filed House Resolution (HR) 1711 that calls on the Committee on Good Government and Public Accountability to look into the policies and guidelines for the registration, utilization, [manufacturing], distribution, and sale of drug products “which appear to be detrimental to public interest”.

Earlier, Velasco also urged the FDA to speed up the process of acquiring permits for local drug manufacturers after the government opened opportunities for the local pharmaceutical industry to boost the country’s response against COVID-19 in addressing the need for vaccines and medicines crisis.

During the briefing, Deputy Speaker Dy pointed out that there seems to be a problem with the process.

“Nakita natin na parang arbitrary kung paano nila pinapakinggan ang WHO or ‘yung iba mabilis ang approval, ‘yung iba matagal,” she said.

“Noong nakausap ko ang mga local pharmaceutical companies natin, they can make the tocilizumab, the remdesivir, pero it seems na nahihirapan silang magpa-register dito mismo sa ating bansa,” she added.

“Marami naman tayo mga foreign clinical trials na pwede nating gamiting basis. Iba kase yung available na siya sa market. Tandaan mo pag sinabi mong compassionate special permit these are for those na malubha na sa ospital. Papaano yung pang prophylactic niya? Paano yung pang prevention niya? Yun yung gusto nating patingnan sa FDA. Baka pwede nilang tingnan sa portion na ito and to make it available,” Dy further said.

For the part of the FDA, Domingo said any investigation would give the agency an avenue to explain their side on the matter.

“We welcome this para pa-explain natin sa ating mga mambabatas kung ano ang ating mga proseso at saka kung ano na ang nagawa natin sa FDA simula ng pandemic,” he said.

Philippines to begin clinical trials on Ivermectin – DOST

Marje Pelayo   •   April 20, 2021

MANILA, Philippines – The Department of Science and Technology (DOST) confirmed that a team of experts has been created to conduct a clinical trial on the veterinary drug, Ivermectin as a potential cure against COVID-19.

The trial is expected to be completed within six months, DOST Secretary Fortunato De La Peña said during Monday’s meeting with President Rodrigo Duterte.

“Ang plano po dito ay iyong mga quarantine centers na malapit sa [Philippine General Hospital] ang pagsasagawaan nila. Mayroon na ring ini-allocate na pondo ang [Department of Health] para dito sa clinical trials na iyan,” he reported to the President during the meeting.

“Hopefully kapag natapos ang trial na iyan ay magkaroon tayo ng reliable estimates sa epekto ng ivermectin bilang anti-viral agent na makaka-reduce ng virus sa spreading sa mga mild at moderate patients,” he added.

Just a week ago, the DOST said there is no need to conduct trials on ivermectin given that there are almost 20 completed and 40 ongoing clinical trials around the world on the said drug.

However, De La Peña noted that they will heed the directive of the DOH or the Food and Drug Administration (FDA) should these authorities require the DOST to conduct a trial.

Meanwhile, the official reported developments on the clinical trials being conducted in other agents such as the virgin coconut oil, steroid and the Tawa-tawa plant as a potential medication against COVID-19.

“May isang gamot sa dengue yun po, iyong Tawa tawa – kasi napatunayan na na nakaka-improve rin ng recovery ng may dengue kaya susubukan naman sa COVID-19,” Dela Peña noted.

The secretary also updated the President on developments regarding locally-made ventilators which was initiated to help resolve growing demand in hospitals amid the surge of COVID-19 cases in the country.

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