The Anti-Red Tape Authority has given the Food and Drug Authority’s Center for Drug Regulation and Research another week until Sunday, May 24, 2021, to explain why the agency has not acted on hundreds of applications for renewed permits and several new drug use applications by pharmaceutical companies.
ARTA served the FDA office a “Show Cause Order” on May 10, 2021 after some drug companies reported delays on the approval of applications dating to as far back as 2014.
ARTA director general Jeremiah Belgica decided to extend the time given to FDA-CDRR after a week has passed without feedback from the agency.
In a congressional inquiry on Monday, May 17, Belgica said this case has always been of interest to him because there appears to be no reason for the delay in approval of applications since most of the applications are for renewal of permits or certificates.
“Since I started in ARTA, this particular process of auto renewal has been a particular interest of ARTA since we observed that these applications rarely get the attention of the CDRR when these are mostly renewals only,” he said in the motu proprio inquiry of the House Committee on Good Government and Public Accountability on the guidelines and policies of Department of Health and FDA that delay the delivery of public health service to the Filipino people.
ARTA noted that only 3 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.
Belgica vowed to commit to getting answers for the delays in the approval of the applications and holding people accountable.
“Let us try to cleanse the system and those who refuse to cooperate, well they can just submit their resignation,” he added, addressing those who are causing delays in FDA.
ARTA encouraged FDA CDRR Director IV Jesusa Joyce N. Cirunay to 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 a Compliance Report with a list of all permit, license, clearance or application issued pursuant to the Show Cause Order.
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.