FDA releases 408 drug applications after ARTA intervention

Published June 2, 2021, 2:07 PM

by Argyll Cyrus Geducos

The Food and Drug Administration (FDA) Center for Drug Regulation and Research (CDRR) has finally released 408 Automatic Renewal (AR) drug applications weeks after receiving a show-cause order from the Anti-Red Tape Authority (ARTA).

ARTA

ARTA made the statement after it ordered FDA-CDRR director 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 her explanation, Cirunay said they have processed 408 out of 412 AR applications. The other four were pending because two were not submitted by the client while the other two were re-routed to other centers or units.

Data from the FDA-CDRR showed that hundreds of the 408 applications were processed from May 14, 2021, the day it received ARTA’s show-cause order and additional affidavits, to May 31, 2021, the deadline set in the order.

Ambica International Corporation’s application, received by the drug center on February 2, 2017, was only approved on May 28, 2021—almost 1,576 days or more than four years since it was filed.

ARTA said it was now evaluating FDA-CDRR’s reply before recommending the appropriate action.

ARTA issued a show-cause order to the drug center on May 11 for its alleged inaction on hundreds of AR drug applications from different pharmaceutical companies. This stemmed from ARTA’s receipt of numerous affidavit complaints from various pharmaceutical companies on their pending drug applications before FDA CDRR.

Cirunay was given seven working days to explain why no administrative and criminal charges should be filed against her. She was granted a motion for extension until May 31 to fully comply with ARTA’s order.

Meanwhile, ARTA asked the public to submit affidavit complaints if they have any pending applications with other government agencies.

Last month, ARTA Director-General Jeremiah 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.

 
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