FDA OKs hospital request for compassionate use of ivermectin vs COVID-19

Robie de Guzman   •   April 8, 2021   •   546

MANILA, Philippines — The Food and Drug Administration (FDA) on Thursday said it has approved a hospital’s application for compassionate use of anti-parasitic drug ivermectin to treat COVID-19.

“Na-grant na iyong special permit for compassionate use [of ivermectin] kasi alam naman naming na investigational product ito against COVID-19. May isang ospital na nag-apply for compassionate use at na-grant na nga ng araw na ito,” FDA director-general Eric Domingo said during the Laging Handa press briefing.

The FDA earlier said that ivermectin is not registered for human use in the country and that the anti-parasitic drug commercially available are for veterinary use.

Domingo 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.

A compassionate special permit allows experimental or unregistered drugs for limited off-label use but this is not an endorsement of its safety and efficacy from the FDA.

Despite the compassionate use permit, Domingo reiterated that the distribution and promotion of ivermectin as a treatment for coronavirus disease remains prohibited.

The FDA also emphasized that a compassionate use permit is different from a certificate of product registration for the drug. There are two pending applications for ivermectin’s certificate of product registration.

A certificate of product registration will allow manufacturers to commercially sell the anti-parasitic drug for human use.

The Ivermectin drug recently made headlines after some lawmakers and even doctors pushed for its use against COVID-19.

But the FDA maintained that ivermectin should first be registered before it can be prescribed for human use against coronavirus disease.

“Hindi po kami kontra sa ivermectin pero kailangan pong irehistro ang produkto at dumaan lamang po sa tamang proseso ng pagisguro po ng quality na makakarating sa tao,” Domingo said.

“Ang ivermectin hindi po siya bakuna. Ang bakuna po ay ginagamit na mag-build ng antibodies sa katawan and to combat kung mayroong possible infection in the future… Kaya magkaiba po ang kaniyang gamit,” he added.

The World Health Organization recently issued a recommendation against using ivermectin in treating COVID-19 patients except for clinical trials due to lack of data indicating its efficacy and benefits. – RRD (with details from Correspondent Aiko Miguel)

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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