The Anti-Red Tape Authority (ARTA) has issued a show-cause order to a Food and Drug Administration (FDA) office for sitting on over 600 drug applications despite full compliance with all documentary requirements.
ARTA Investigation Enforcement and Litigation director Jedrek Ng on Tuesday forwarded the order to FDA Center for Drug Regulation and Research (CDRR) director Jesusa Cirunay to allow the agency to explain the circumstance.
There are at least 23 affidavits of several pharmaceutical companies that complained of processing delays by FDA-CDRR on their applications filed as far back as 2014.
“If we look at these applications, these are not complicated applications. Most of them are for automatic renewal for products na we use already and for products that need registration or approval. Some don’t even pose risk to people or end-users,” said ARTA Director General Jeremiah Belgica.
“We are at a loss why the agency has not acted on the applications. We heard this has been happening quite frequently, based on complaints from applicants,” he added.
Cirunay was given seven working days from receipt of the Order to conduct an inventory of all pending permits, licenses, clearances, or applications and to immediately release all applications that have been pending beyond the prescribed processing time.
The agency is also expected to submit to ARTA a compliance report with a list of all permits, licenses, clearances, or applications issued pursuant to the Show Cause Order.
“This is plain and simple delay and bureaucracy issue. I want them to explain why they have to the process any difficult than it is. Don’t toy with bureaucracy when it’s the peoples’ lives at stake,” Belgica said.
If Cirunay fails to comply, ARTA will file formal charges against her in accordance with Republic Act no. 11032 or the Ease of Doing Business and Efficient Government Service Delivery law before the Office of the Ombudsman.
Belgica also urged Health Secretary Francisco Duque III and FDA Director General Eric Domingo to remove, if necessary, their erring officials and personnel.