ARTA gives FDA ultimatum until May 24

Published May 17, 2021, 3:43 PM

by Bernie Cahiles-Magkilat

The Food and Drug Administration (FDA) was given until next week, May 24, by the Anti Red Tape Authority (ARTA) to explain for sitting down on hundreds of drug applications from various pharmaceutical companies with complete requirements since 2013.

On May 10, ARTA issued a Show Cause Order to the FDA Center for Drug Regulation and Research (CDRR) after some pharmaceutical companies filed over 20 affidavits detailing the alleged delays of the office in approving their applications that were filed as far back as 2013 or so. ARTA said these involved over 400 pending applications, mostly from Philippine pharmaceutical companies, for automatic renewal.

The FDA CDDR was given seven working days to respond and comply with the order on May 10, but filed on May 11. Excluding holidays and weekends, the ultimatum is on May 24. So far, ARTA has not heard from the the FDA CDRR yet.

ARTA will proceed with the filing of administrative or criminal charges against FDA CDRR Director IV Jesusa Joyce N. Cirunay at the Office of the Ombudsman if the FDA official cannot meet the deadline for violation of Republic Act no. 11032 or the Ease of Doing Business and Efficient Government Service Delivery.

Based on the ARTA Order, the FDA unit was required to immediately conduct an inventory of all transactions pending beyond the prescribed processing time stated in the agency’s updated Citizen’s Charter; issue/release the permits, certification, and clearances corresponding to applications; and submit a compliance report within the period of 7 working days from receipt of the order.

In a congressional inquiry on Monday, May 17, Secretary Jeremiah Belgica, ARTA Director General, said this case has always been of interest to him because there appears to be no reason for the delay in approval of applications.

In the motu proprio inquiry of the House Committee on Good Government and Public Accountability on the guidelines and policies of DOH and FDA that hamper the delivery of public health service to the Filipino people, Belgica related that since he took office as ARTA chief, this particular process of auto renewal has been of particular interest to ARTA. He wondered as to the several applications that have been pending with the FDA office considering these are only meant for automatic renewal.

For auto renewal, only three documents are needed to get approval, namely the application form, the proof of payment, and an affidavit stating that no changes in the formulation of the medicine are made, he said.

ARTA is expecting even more affidavits to be filed in the coming days.

Belgica vowed to commit to getting answers for the delays in the approval of the applications and holding people accountable.

“We commit to that, that is our commitment,” he said.

“Linisin po natin at ‘yung mga ayaw po makipag-cooperate, mag-resign nalang po kayo (Let us clean up and those who refuse to cooperate, just resign“ Belgica said in a mix of English and Filipino.

FDA CDRR Director IV Jesusa Joyce N. Cirunay must conduct an inventory of all pending permits, licenses, clearances or applications; immediately release all said applications which have been pending beyond the prescribed processing time; and submit to ARTA a Compliance Report with a list of all permit, license, clearance or application issued pursuant to the Show Cause Order.

Deputy Speaker Jose Atienza, Jr. congratulated ARTA for its work to make the provision of services more seamless for Filipinos, especially amid the COVID-19 pandemic.

“The nation depends on a very efficient ARTA which could prevent a lot of corruption in government today,” he said.

 
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