ARTA recommends raps vs. FDA exec for inaction on applications

ARTA recommends raps vs. FDA exec for inaction on applications

MANILA – The Anti-Red Tape Authority (ARTA) has endorsed to the Office of the Ombudsman the filing of charges against the head of the Food and Drug Administration – Center for Drug Regulation and Research (FDA – CDRR) for sitting on hundreds of Automatic Renewal (AR) drug applications.

In its motu propio disposition dated June 8 addressed to Ombudsman Samuel Martires, the ARTA recommended 412 counts of failure to render government services within the prescribed processing time under Section 21 (e) of the Republic Act No. 11032 or the Ease of Doing Business and Efficient Government Service Delivery Act of 2018 against FDA – CDRR Director Jesusa Joyce N. Cirunay.

This, after the red tape watchdog found a “prima facie case” following Cirunay’s admission that “there has been a delay in the processing of applications before her office.”

The admission was stated in Cirunay’s reply letters to ARTA’s May 11 show cause order, which gave her seven working days to explain why no administrative or criminal case should be filed against her.

“Cursory perusal of Respondent Director Cirunay’s attachment in both her Letters would show that there has been a delay in the processing of the Four Hundred and Twelve (412) applications. In fact, none of the applications met the mandate of R.A. No. 11032, specifically as to processing time,” the ARTA’s disposition read.

The authority also noted that FDA’s Citizen’s Charter only provides 20 days for the release and processing of applications for renewal of registration from receipt of the complete requirements.

Some of the AR drug applications have been with FDA – CDRR as far back as 2014.

Meanwhile, the ARTA also lodged a formal complaint against Cirunay for claiming that they only have one pending application in view of the unacted 2,250 low risk to no risk AR applications for Certificate of Product Registration discovered by no less than the Authority when it conducted an inspection in January. This, because its validation with the Philippine Chamber of Pharmaceutical Industry, Inc. (PCPI) revealed that there are still eight (8) remaining AR applications awaiting action.

“In view of the foregoing facts, this Complaint-Affidavit is filed for the purpose of initiating the necessary action against Jesusa Joyce N. Cirunay, Director IV of the FDA-CDRR, and for other appropriate crimes as the Honorable Ombudsman may see fit and proper to indict Respondent,” it said. (PNA)

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