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

Marje Pelayo   •   April 21, 2021   •   381

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.

Self-test kits na aprubado ng FDA, mabibili lang sa mga otorisadong drug outlets – DOH

Robie de Guzman   •   January 25, 2022

MANILA, Philippines – Maaari nang mabili sa mga lisensiyado at aprubadong drug outlets ang dalawang brand ng COVID-19 Antigen Self-test kits, ayon sa Department of Health (DOH).

Ito ay matapos aprubahan ng Food and Drug Administration (FDA) ang aplikasyon ng special certification ng dalawang kumpanya para sa self-test kits na tinatawag na Abbot’s Panbio at Labnovation Technologies SARS-CoV2 Antigen rapid test.

Una nang iniulat ni FDA officer in charge Oscar Gutierrez na nabigyan na ng sertipikasyon ang dalawang brand at maaari nang gamitin sa bansa.

“Ang Panbio COVID-19 antigen self-test kit ng Abbot available po siya sa 1, 4, 10, and 20 tests per box. At yung SARS-CoV-2- antigen rapid test ng Labnovation Technologies Incorporated ito po ay self-test for home use din. Available po siya ng 2,5, and 20 tests per box,” ani Gutierrez.

Pero paalala ng Department of Health na may tamang proseso at panahon ang paggamit ng self-test kits upang masegurong tama ang ilalabas nitong resulta.

Ayon kay Health Undersecretary Maria Rosario Vergeire, mas mainam gamitin ang self-test kits kung may sintomas ang isang tao upang matiyak na accurate ang resulta ng kit.

“Please use it rationally, use it at the right time at tamang proseso. Ibig sabihin gagamit lang po kayo ng test kapag kayo ay nakakaramdam ng sintomas dahil ang antigen test po ay most accurate pa rin kapag kayo po ay nakakaranas ng sintomas dulot ng COVID-19,” ani Vergeire.

Ang panawagan naman ng Infectious Diseases expert na si Dr. Rontgene Solante, bigyang-prayoridad sa paggamit ng test kit ang mga may sintomas at nasa vulnerable population gaya ng mga matatanda upang agad malaman ang kanilang kondisyon at malapatan ng karampatang lunas.

“I-prioritize natin ang paggamit nitong antigen test doon sa mga may symptoms at vulnerable population. Bakit? Because these are the population that are kailangan na kung mag-positive meron tayong gamot na mga anti-viral or monoclonal antibodies para hindi po lalala ang mga infections nila to severe COVID at hindi sila maho-hospitalize,” ani Solante.

May pagkakaiba rin ang Antigen self-test kits sa rapid test kits na kalimitang ginagamit sa mga ospital at laboratory kaya payo ng DOH sa publiko na basahing mabuti ang instructional manual na nakapaloob sa bibilihing test kits.

“Ang kaibahan nito ay iyong pong specimen na kinokolekta. Ito pong mga self-administered test kits usually would have nasal specimens po ang kinukuha. Ibig sabihin kapag nasal specimen, di ganun kalalim sa inyong ilong ang pagkuha ng specimen for this test kits compared doon sa current na kailangan na guided siya ng health worker at mas malalim ang kinukuhang specimens para rito,” ang paliwanag ni Vergeire.

Paalala rin ng DOH na ang self-test kits ay available lamang sa mga otorisadong botika at hindi maaaring bilhin online.

“Bumili lamang ng self-administered test kits na aprubado nf FDA o galing po sa mga FDA-licensed drug outlets para lagi po tayong makakasiguro ana ito ay ligtas at lagi po tayong makakaseguro na makakapagbigya ng accurate na resulta,” ani Vergeire.

Paalala rin ng DOH sa publiko na i-check ang expiration date ng self-test kits at itago ang opisyal na resibo ng botikang pinagbilhan nito.

Sa ngayon ay isinasapinal na ng DOH ang guidelines, kaakibat ang evaluation ng Research Institute for Tropical Medicine at FDA hinggil sa COVID-19 self-test kits.

“Ang kagawaran namn po ng kalusugan are on our final stages dito po sa pagssusulat ng polisiya at guidelines kung paano natin gagamitin ito sa mercado,” ani Vergeire.

“Siguro po within the week makakapaglabas na tayo nitong guidelines natin,” dagdag pa niya.

FDA grants special certification to two self-antigen test kit brands

Maris Federez   •   January 25, 2022

MANILA, Philippines — The Food and Drug Administration (FDA) announced Monday (January 24) that it has given its nod to two brands of self-administered COVID-19 antigen test kits.

During President Rodrigo Duterte’s pre-recorded Talk to the Nation, FDA Officer-in-Charge Oscar Gutierrez said it has granted special certification to Panbio COVID-19 Antigen Self-Test by Abbot Laboratories, and to SARS-Cov-2 Antigen Rapid Test from Labnovation Technologies, Inc.

Panbio COVID-19 Antigen Self-Test kit will be available in 1, 4, 10, or 20 tests per box, while SARS-Cov-2 Antigen Rapid Test will be available in 2, 5, or 20 tests per box.

Gutierrez also confirmed Duterte’s earlier announcement that they have pulled out around 86 antigen test kits from the local market.

“Hindi nila na-meet ang RITM (Research Institute for Tropical Medicine) performance validation habang mayron silang special certification o ‘di kaya ‘di po sila rehistrado, authorized o kaya sinurender ng special certification holder ‘yong kanilang certification,” he said.

Gutierrez added that the agency was able to seize around 50,000 test kits and 70,000 boxes of fake medicine and antigen tests in Manila last week.

Gutierrez said the FDA continues to monitor a product, such as the self-test kit, that has been given special certification even after it reaches the market.

He said FDA operatives collect samples and send them back to the RITM to test them for actual use.

The Research Institute for Tropical Medicine is the office mandated to do performance validation of testing kits.

Gutierrez added that as of January 18, they have already received 11 applications from manufacturers.

He said the special certification will be issued for self-test kits to make them accessible and available to the public for home and individual use. —/mbmf (with details from UNTV Correspondent Nel Maribojoc)

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)

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