ARTA recommends 412 cases vs FDA exec over processing delays

MANILA, Philippines — The Anti-Red Tape Authority has endorsed to the Office of the Ombudsman the filing of charges against a ranking exec of the Food and Drug Administration for sitting on hundreds of automatic renewal drug applications.

In a statement sent to reporters, the ARTA disclosed that it recommended 412 counts of failure to render government services within the prescribed processing time against FDA Center for Drug Regulation and Research Director Jesusa Joyce Cirunay.

In its motu propio Disposition dated Tuesday, June 8 and addressed to Ombudsman Samuel Martires, the red tape watchdog pointed to alleged violations of the Ease of Doing Business and Efficient Government Service Delivery Act of 2018. 

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

The admission came in Cirunay’s response to ARTA’s show-cause order, where Cirunay was asked to do an inventory of the pending applications and release them within seven days.

“Cursory perusal of Respondent Director Cirunay’s attachment in both her Letters would show that there has been delay in the processing of the Four Hundred and Twelve (412) applications,” the ARTA’s Disposition read.

"In fact, non of the applications met the mandate of R.A. No. 11032, specifically as to processing time."

RELATED: FDA to cooperate with anti-red tape body on delays in drug applications

What happened?

To recall, the ARTA accused the department of "sitting on" AR drug applications after 23 affidavits of pharmaceutical firms complained of delays in the processing of their applications filed as far back as 2014.

The government anti-red tape body also lodged a formal complaint against Cirunay for claiming that FDA only had one pending application at an inspection in January.

However, its validation with the Philippine Chamber of Pharmaceutical Industry, Inc. disclosed that there are still eight remaining AR applications awaiting action, the ARTA said.

ARTA in its statement 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. 

“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.

Last March, ARTA also asked the FDA to expedite application process for ivermectin, an anti-parasitic medication being pushed for the prevention and treatment of COVID-19 despite insufficient evidence supporting its use.