Anti red-tape body to FDA: Explain delay in renewing applications of over 600 drugs

ABS-CBN News

Posted at May 12 2021 08:29 AM | Updated as of May 12 2021 01:32 PM

Anti red-tape body to FDA: Explain delay in renewing applications of over 600 drugs 1
Food and Drug Authority at the one-stop center in Ali Mall, Cubao. ABS-CBN News/file

MANILA (UPDATE) - The Anti-Red Tape Authority (ARTA) on Tuesday asked the Food and Drug Administration (FDA) to explain the delay in the renewal of product registration of over 600 drugs.

The FDA Center for Drug Regulation and Research has 7 days to respond to the show-cause order, ARTA director-general Jeremiah Belgica said Wednesday.

Should it fail to answer to the order, the FDA center's officials and workers could face administrative complaints before the Office of the Ombudsman, according to Belgica.

"Hindi na ito science, burokrasya na ang nagpapatagal dito," he told ABS-CBN's Teleradyo.

(It's not the science but the bureaucracy that's delaying applications.)

"Nanawagan po kami kay FDA director-general Eric Domingo at (Health) Secretary Duque na linisin na po natin, tanggalin na po natin ang mga nagpapahirap sa atin d'yan."

(We call on FDA director-general Eric Domingo and Secretary Duque to cleanse their ranks.)

Belgica said drugmaker applications should have been granted "automatic renewal," as companies only have 3 requirements: application form, proof that the company has paid fees, and an affidavit stating they have not changed the formulation.

"Ako po'y hindi doktor pero nakita ko pong ang iba po d'yan ay talagang matagal nang ginagamit," he said.

(I'm not a doctor but I could see some of the drugs have been used for a long time.)

" 'Yung iba sinasabi, 'Hindi ba delikado 'yan kasi minamadali natin?' Ang sagot po d'yan, hindi ho delikado 'yan dahil ayon sa rules nila 'pag ang isang gamot ay ginagamit na matagal na at for renewal lamang ng registration, 3 simpleng dokumento lang po ang kinakailangan nila para automatically ma-renew."

(Some are asking, "Isn't it dangerous to rush passing applications?" It's not dangerous because under FDA rules, if a drug has been used for a long time and the registration is up for renewal, there are 3 simple documents they need to accomplish for automatic renewal.)

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In a separate interview on TeleRadyo on Wednesday, Domingo said his agency would cooperate with the investigation. 

“FDA will cooperate fully with the authorities sa pag investigate dito para makita natin kung meron ngang problema,” he said.

(The FDA will cooperate fully with authorities investigating this to really find out the problem.)

Domingo said they are already looking for the applications said to be pending before the FDA’s Center for Drug Regulation and Research. 

“Yung aming legal service ay tumutulong na rin na hanapin, i-trace itong mga applications na ito para malaman kung may pagkukulang man at kung may problema talaga na hindi naaksiyunan. Kailangang ma-trace at magkaroon ng resolution lahat ng application,” he said.

(Our legal service is also helping search, trace these applications for us to determine if there were really lapses and if there were also problems that were not addressed.) 

The ARTA, in a statement on March 29, urged the FDA to expedite its processing of applications for the use of anti-parasitic drug ivermectin.

The FDA has since allowed 5 hospitals to use ivermectin for COVID-19 treatment. Last week, it also approved the drug for human use.

But Domingo said that ivermectin is a prescription drug.

“Before this, kaya tayo laging nagbababala noon ang mga registered lang na Ivermectin sa Pilipinas ay pang hayop, mga pang veterinary products at wala pong pang tao na nagreregister dito sa Pilipinas for the past 20 to30 years. At least ngayon may nag parehistro na na magmanufacture ng tableta na pang tao ang kaniyang formulation,” he added.

(Before this, the reason why we always issue warnings is because the registered ivermectin in the Philippines is for veterinary products and no one has registered this for the past 20 to 30 years for human use. At least now, someone has registered it and would manufacture tablets with the formulation for human.) 

Senate President Vicente Sotto III earlier said he would seek an investigation into the alleged opposition of the FDA on the use of ivermectin for COVID-19 treatment.

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