NEARLY all pending drug applications for automatic renewal (AR) before the Food and Drug Administration Center for Drug Regulation and Research (CDRR) were released after the body was instructed to do so by May 31, the Anti-Red Tape Authority (Arta) said.
The anti-red tape watchdog reported on Wednesday that 408 of the 412 AR applications were processed within the prescribed period, as communicated by FDA CDRR Director IV Jesusa Joyce N. Cirunay.
“The four remaining applications are pending because two were not submitted by the client while the other two were re-routed to other centers or units,” Arta said, citing Cirunay.
On May 11, Arta issued a show-cause order for Cirunay to explain the hundreds of drug applications that have remained pending despite complete submission of requirements. These applications were filed as far back as 2014 or so.
Arta Director General Jeremiah Belgica explained previously that AR applications are not deemed complicated transactions. These products, he said, have been previously consumed or only have low to no risk when used. Cirunay was then given seven working days from receipt of the order to do an inventory of all pending permits, license, clearance or application. She was also told to immediately release all said applications which have been pending beyond the prescribed processing time.
In addition, Arta ordered the FDA official to submit a compliance report with a list of all permits, license, clearance or application issued in accordance with the show-cause order.
Cirunay was granted a motion for extension until end of May to fully comply with the order.
“The Authority is now evaluating FDA CDRR’s reply before recommending an appropriate action,” Arta said.
“After FDA’s full compliance with Arta’s show-cause order, we are now verifying with the pharmaceutical companies who filed affidavits if their applications have really been released. We are also reviewing FDA CDRR’s response to see if any violations were made and if cases should be filed,” it added.
The anti-red tape agency earlier said it will be compelled to file formal charges against Cirunay before the Office of the Ombudsman should she fail to comply with the order. This is in line with the implementation of Republic Act 11032 or the Ease of Doing Business and Efficient Government Service Delivery law, the Arta said.
First-time offenders will be given 6-month suspension, Belgica noted, while two-time violators will be facing imprisonment.
Arta is “calling on the public to submit affidavit complaints if they have any pending applications with other government agencies.”
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