ARTA closely watching FDA official for 'red tape'
Despite the release of approval on hundreds of applications kept for years in her office, the Food and Drug Administration official is not yet off the hook.
Anti Red Tape Authority (ARTA) Director General Jeremiah Belgica said his office is now evaluating the reply of Jesusa Joyce N. Cirunay, Director IV of the
Cirunay beat the May 31 deadline given to her by ARTA to respond to complaints by applicants for automatic renewal of applications filed in her office since.
“The delays already happened. We previously issued Automatic Renewal Orders and Now Show Cause na. We are evaluating the explanation for the delays,” said Belgica.
Belgica said that as of today, June 2, 2021, the FDA office released hundreds of Automatic Renewal (AR) drug applications from when it received the Anti-Red Tape Authority's show-cause order on 14 May 2021 until its May 31 deadline.
Based on Cirunay’s explanation, they have processed 408 out of 412 AR applications.
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, Cirunay explained.
Data from the FDA CDRR showed that hundreds of the 408 applications were processed from 14 May 2021, when it received ARTA's show-cause order and additional affidavits, to 31 May 2021, its final day to reply to the said order.
For instance, ARTA said that Ambica International Corporation's application, which was received by the drug center on 2 February 2017, was only approved on 28 May 2021—almost 1,576 days or four years, three months, and 26 days from its date of application.
ARTA issued a show-cause order to the drug center on May 11 for its alleged inaction on hundreds of AR drug applications from different pharmaceutical companies. This stemmed from ARTA's receipt of numerous affidavit complaints from various pharmaceutical companies on their pending drug applications before FDA CDRR.
Cirunay was given seven working days to explain why no administrative and criminal charges should be filed against her. She was granted a motion for extension until May 31 to fully comply with ARTA's order.
The Authority is calling on the public to submit affidavit complaints if they have any pending applications with other government agencies.
Republic Act 11032 or the Ease of Doing Business and Efficient Government Services Delivery Act of 2018 requires all services in government to be classified as Simple, Complex, or Highly Technical and should be delivered or acted upon within the prescribed period of 3, 7 or 20 days respectively.
Failing to act on applications within the prescribed processing times will render applications to be automatically deemed approved or automatically extended, as the case may be, by operation of law and may expose the government officer handling the application as well as the head of the office or agency to possible administrative sanctions or even criminal liability.
Through ARTA’s Order 2020-02, all government offices are expected to comply to the 3-7-20 rule before March 7, 2020.