FDA: 6 hospitals have secured special permit for ivermectin use vs COVID-19
Robie de Guzman • May 5, 2021 • 235
MANILA, Philippines — Another hospital has secured a compassionate special permit (CSP) for the use of ivermectin to treat patients with coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Wednesday.
FDA director-general Eric Domingo said there are now six hospitals within and outside Metro Manila that have been allowed limited use of the anti-parasitic drug on COVID-19 patients.
“That means the doctors in the hospitals can prescribe it [ivermectin],” he said in an online forum.
Domingo declined to identify these hospitals with CSP since the FDA doesn’t want to “violate the privacy of the patients.”
“Of course, the hospitals can freely identify themselves. We’re not stopping them,” he added.
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.
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 prescribe the drug to treat COVID-19 patients are required to report to the FDA on a monthly basis. They will also be held liable for possible side effects.
The FDA also reiterated 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 stressed that the drug is still an investigational product and is not yet approved as COVID-19 treatment in the country.
The clinical trial for ivermectin as possible COVID-19 treatment is expected to start in May or June.
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
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.
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)
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