Second hospital given compassionate permit on ivermectin use vs COVID-19 – FDA

Robie de Guzman   •   April 16, 2021   •   323

MANILA, Philippines – Another hospital has been granted with compassionate special permit (CSP) to use anti-parasitic drug ivermectin to treat patients with COVID-19, the Food and Drug Administration (FDA) said Friday.

“Two hospitals na actually na nag-apply sa atin ang nabigyan ng CSP,” FDA director-general Eric Domingo said in an interview with ANC.

Domingo, however, did not specify the names of these hospitals.

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.

The agency also emphasized 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 reiterated 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, he said.

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

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

The agency also stressed that the ivermectin products registered for human use in the country were in topical formulations under prescription use only. – RRD (with details from Correspondent Aiko Miguel)

DTI: Halos 200-libong manggagawa, balik-trabaho sa ilalim ng GCQ

Robie de Guzman   •   May 14, 2021

MANILA, Philippines — Maaari nang makabalik sa trabaho ang nasa 200-libong empleyado matapos na ibalik sa general community quarantine “with heightened restrictions” ang National Capital Region (NCR) at mga karatig-lalawigan.

Ayon kay Trade and Industry Secretary Ramon Lopez, magiging daan ang paglipat sa GCQ ng NCR, Bulacan, Cavite, Rizal, at Laguna – tinatawag na NCR Plus – upang mapababa ang bilang ng mga nawalan ng trabaho noong kasagsagan ng enhanced community quarantine (ECQ).

“As we further open the economy, we are expecting to bring back 200,000 to 300,000 jobs to lessen the number workers displaced since the start of the ECQ,” ani Lopez.

Noong nasa ilalim ng ECQ ang NCR Plus, umabot sa 1.5 milyon ang bilang ng mga Pilipino nawalan ng trabaho dahil sa coronavirus pandemic.

Nabawasan ito at naging isang milyon noong ipinatupad ang modified ECQ.

Ayon kay Lopez, sa ngayon ay aabot pa sa 700-libong manggagawa ang hindi pa rin nakakabalik sa trabaho dahil sa limitadong operasyon ng ilang establisimyento gaya ng mga restaurant, at barbershop. – RRD (mula sa ulat ni Correspondent Joan Nano)

DOH says no to proposed vaccine pass for access to indoor establishments

Robie de Guzman   •   May 14, 2021

MANILA, Philippines — The Department of Health (DOH) on Friday said it is not recommending the proposal to use a “vaccine pass” that would allow persons already inoculated against COVID-19 to have access to business establishments.

“Hindi po kami sang-ayon sa ganyang pagpapalakad o kaya ay magkaron tayo ng mga ganyang proseso,” Health Undersecretary Maria Rosario Vergere said in a virtual press briefing.

Vergeire said the DOH is not in favor of the proposal as there is no sufficient evidence yet to say that a person who has already received two doses of the COVID-19 vaccine can no longer be infected or spread the virus.

She added that initial studies have shown that the currently available vaccines against coronavirus cannot adequately block the virus.

“Wala pa ho tayong sufficient evidence to say na ang isang taong with complete doses of vaccines already would have that kind of immunity, na hindi na siya magkakaroon ng sakit o makakapanghawa dahil nga po dito sa mga paunang mga ebidensiya na ibinigay sa atin, hindi po nakakapag-block ng transmission adequately ang mga bakuna na mayroon tayo ngayon,” she said.

“As we have said, ang pinaka-assurance o benepisyong nakukuha natin ngayon sa vaccines is reducing severe infections and hospitalization. As to preventing mild to moderate infections, hindi pa rin po tayo nagbibigay ng ganyang assurance sa ating mga kababayan,” she added.

Vergeire also reminded the public, especially those who have completed the two doses of the COVID-19 vaccine, to still observe health protocols against COVID-19.

“Even if you are fully vaccinated, meaning you have completed two doses, kailangan pa rin natin magpatupad ng minimum health protocols,” she said.

“Itong sinasabing vaccine pass ay hindi pa rin mairerekomenda ng Kagawaran ng Kalusugan,” she added.

Anti-Red Tape Authority to probe FDA officials over delayed permit applications

Aileen Cerrudo   •   May 14, 2021

MANILA, Philippines — The Anti-Red Tape Authority (ARTA) said it will investigate officials of the Food and Drug Administration (FDA) over delayed processing of permit applications.

During the Laging Handa press briefing, ARTA Director Atty. Jeremiah Belgica said they already filed show cause orders to the FDA on Tuesday (May 11) for alleged 600 pending drug certification applications since 2014.

He also reported that 23 pharmaceutical companies have filed affidavits against the FDA for its lack of action concerning their applications.

Belgica urged the FDA to release the pending permit applications. He said that the processing of these applications should not take long since most of the permits are under automatic renewal applications or products that have previously been approved. He stressed that these products do not need to be further reviewed.

“Simpleng affidavit lang po ang nire-require ng FDA dito. So ibig sabihin kapag naisubmit na ang mga affidavit na iyan, automatically renewed na dapat po iyan. Pero sa ganito hindi nagiging automatic ang renewal,” he said.

(The FDA is only requiring a simple affidavit, meaning, once you have submitted one it will automatically be renewed. However, with the current situation, it is not being automatically renewed).

Belgica also said ARTA is coordinating with the Presidential Anti-Corruption Commission (PACC) to conduct lifestyle checks on officials allegedly involved in red tape.

He said that red tape is connected to corruption. He also reported that the complaints exceed more than 600 since the agency is still receiving complaints against centers under the FDA.

ARTA has yet to release the number of additional complaints.

Belgica also urged the FDA and the Department of Health (DOH) to replace erring personnel to avoid any hint of corruption in the agencies.

“Tanggalin na ang mga dapat tanggalin at dapat po maglagay tayo ng mga tauhan na talagang magrereporma,” he said.

(Remove those needed to be removed and replace them with personnel who would side the reform.) AAC

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