By NG Seruela
The Anti-Red Tape Authority (ARTA) recommended on Wednesday (June 9) the filing of charges to the Office of the Ombudsman against Food and Drug Administration-Center for Drug Regulation and Research (FDA-CDRR) Director over “sitting on hundreds of Automatic Renewal (AR) drug applications.”
In a statement, ARTA said that it 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 Cirunay.
The ARTA said that a red tape watchdog found a “prima facie case” following Cirunay’s admission that “there has been delay in the processing of applications before her office.”
“The said 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,” the statement read.
ARTA’s cause of action came from 23 affidavits submitted by several pharmaceutical companies complaining about the delays committed by the FDA-CDRR on their applications that were filed as early as 2014.
READ MORE: FDA: CDRR officer issued show-cause order has right to explain
Meanwhile, the ARTA also filed 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. “ –rir
