ARTA chief urges Duque: Cleanse FDA

Published May 15, 2021, 9:19 AM

by Argyll Cyrus Geducos

The Anti-Red Tape Authority (ARTA) has called on the Department of Health (DOH) to put people in the Food and Drug Administration (FDA) who will initiate reforms in the agency.

Anti-Red Tape Authority (ARTA) Director-General Jeremiah Belgica (Photo from ARTA)

ARTA Director-General Jeremiah Belgica made the statement after ARTA issued a show-cause order FDA Center for Drug Regulation and Research (CDRR) Director IV Jesusa Cirunay to “explain why no administrative or criminal case should be filed” against her for supposedly sitting on over 600 drug applications filed since 2014 despite completeness of submission of various pharmaceutical companies.

In a virtual public briefing, Belgica asked Health Secretary Francisco Duque III and FDA Director-General Eric Domingo to cleanse the FDA as he pointed out that more complaints against the agency are pouring in.

“Iyong reklamo hong pumapasok, Center for Drugs pero pati rin ho sa ibang mga centers ay may mga pumapasok na din po sa amin na mga affidavits (The complaints we have are for the CDRR but we have affidavits coming in complaining about other centers of the FDA),” he said during the Laging Handa briefing.

“Kaya ang hiling ko ho ‘no kina DG Domingo at saka kina Sec. Duque ay linisin na ho natin ‘no, tanggalin na po natin ang dapat tanggalin po diyan at maglagay ho tayo siguro ng mga tao na dapat ho talagang mag-reporma kasama po nila (That’s why I ask DG Domingo and Secretary Duque to clean the FDA and fire those who need to be fired and place people who will initiate reforms with them),” he added.

Belgica reitereated his call for the FDA CDRR to release all applications that have been pending since 2013.

“Sobra na po iyan, iyan po ayaw na ayaw ng Pangulo (That’s too much. That’s is what President Duterte hates),” he said.

“Kaya ho atin na po silang binibigyan ho nang mas maiksi na leash para po ayusin ang mga bagay na iyan (That’s why we are going to keep them on a short leash so they will shape up),” he added.

Belgica explained that the pending application for permits involved automatic renewals and not applications for new products that need to be tested first before releasing it to the market.

“Simpleng affidavit lang ho ang niri-require actually ng FDA dito na katunayan na wala hong binagong formulation (The FDA only requires a simple affidavit for these applications, meaning there were no new requirements sought),” he said.

“Pagka-submit ho dapat ng affidavit na iyan automatically renewed na ho dapat iyan basta nabayaran na at nai-file iyong application (The application should be automatically renewed after the submission of the affidavit, payment of fees, and filing of the application),” 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; and submit to ARTA a Compliance Report with a list of all permit, license, clearance or application 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 the Ease of Doing Business Act before the Office of the Ombudsman.

First offenders will be suspended for six months, and jail term for second time offers.

 
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