ARTA calls out FDA anew for sitting on over 600 applications

Published May 11, 2021, 3:57 PM

by Bernie Cahiles-Magkilat

 The Anti-Red Tape Authority (ARTA) has issued a show-cause order to a Food and Drug Administration (FDA) office for sitting on over 600 drug applications filed since 2014 despite completeness of submission of various pharmaceutical companies.

ARTA Investigation Enforcement and Litigation Director Jedrek Ng on Tuesday, May 11, ordered 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. 

ARTA’s action stemmed from the 23 affidavits of several pharmaceutical companies detailing the alleged delays committed by FDA-CDRR on their applications filed as far back as 2014 or so.

ARTA Director General Jeremiah Belgica noted that the pending applications were for automatic renewal  only for products that are in use already while others are low to no risk to people. Given the nature of the applications, Belgica said, these can already be approved by the Center Director herself.

Belgica expressed disappointment why the applications remained inacted. He also noted the fact that

FDA, particularly its Center for Drugs, often figured in red tape.

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 to Republic Act no. 11032 or the Ease of Doing Business and Efficient Government Service Delivery law before the Office of the Ombudsman.

 “This is plain and simple na delay and bureaucracy,” said Belgica stressing that ART would like FDA to explain why they are making it difficult for Filipinos to process these applications. He told FDA that has been feed up with their explanations before. It could be recalled that FDA was among the very first government agencies called out by ARTA due to red tape processes in the agency.

First offenders will be suspended for 6 months, and jail term for second time offers.

Belgica warned FDA that ARTA has teeth to enforce the law. 

Belgica vowed to spend the remaining time in office to make the offenders answerable to red tape charges. 

 “We have spoken to you so many times and now there is really a time for everything and a time for reckoning,” he furthe said. Belgica also urged Health Secretary Francisco Duque III and FDA Director General Eric Domingo to remove, if necessary, their erring officials and personnel.