Metro Manila (CNN Philippines, May 11) – The Anti-Red Tape Authority issued on Tuesday a show-cause order against a Food and Drug Administration official for 600 drug applications pending in her office.
ARTA ordered FDA Center for Drug Regulation and Research (FDA-CDRR) Director Jesusa Cirunay to explain why the drug applications remain pending despite the complete submission of requirements by involved pharmaceutical firms.
The complaint stemmed from the 23 affidavits of several pharmaceutical companies which detailed the alleged delays committed by FDA-CDRR on their applications filed since 2014.
“Pag titingnan po ito ang mga applications na ‘to di ito kumplikado. Ito yung mga aplikasyong for automatic renewal. Ito ay mga produkto na dati ng ginagamit at ngayon ay gusto lang i-register o yung iba naman ay low to no risk sa taumbayan,” ARTA Director General Jeremiah Belgica said.
[Translation: If you will look into these applications, these are not complicated. These applications are for automatic renewal. These products have been used before but will be registered now, or those have low to no risk to our citizens.]
Cirunay has been given seven working days from her receipt of the order to conduct an inventory of all pending permits, licenses, clearances or applications.
ARTA also asked Cirunay to immediately release all applications which have been pending beyond the prescribed processing time and submit to the agency a compliance report and list of all permits, licenses, clearances or applications issued pursuant to the order.
If Cirunay fails to comply with the order, ARTA said she may be charged under Republic Act 11032 or the Ease of Doing Business and Efficient Government Service Delivery Act before the Office of the Ombudsman.
Belgica warned that according to the law, Cirunay can be suspended up to six months if she’s found liable during her first offense. If she committed such mistake again, she can be jailed for her offense.
Belgica also urged Health Secretary Francisco Duque III and FDA Director General Eric Domingo to remove erring officials and personnel.
“We would really go all out sa inyo dahil sa dami ho ng tambak na applications (because of too many pending applications). We have spoken to you so many times and now there is really a time for everything and a time for reckoning,” said Belgica.
CNN Philippines is requesting comment from FDA about the ARTA order.
