The Anti-Red Tape Authority (ARTA) expects more affidavits to be filed against an office of the Food and Drug Administration (FDA) for its inaction on drug applications of various pharmaceutical companies that turned over complete requirements.
Jeremiah Belgica, ARTA director-general, disclosed this at the motu proprio inquiry of the House Committee on Good Government and Public Accountability yesterday.
This developed as the deadline nears for the Center for Drug Regulation and Research (CDRR) to reply to the show-cause order slapped by ARTA on May 10 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 2014 or so.
The FDA CDDR was given seven working days or until May 23 to respond and comply with the order.
Belgica said only three documents are needed to approve applications, 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 said CDRR director Jesusa Joyce 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.
According to ARTA, Cirunay may face administrative or criminal charges for violation of Republic Act no. 11032 or the Ease of Doing Business and Efficient Government Service Delivery law before the Office of the Ombudsman if she fails to comply. – Irma Isip
