ARTA evaluating FDA office’s response to allegations of inaction on drug applications

The Anti-Red Tape Authority (ARTA) on Friday said it was evaluating the initial response of an office of the Food and Drug Administration (FDA) to allegations that it failed to act on hundreds of drug applications for automatic renewal.

FDA Center for Drug Regulation and Research (CDRR) director Jesusa Cirunay submitted to ARTA on Monday a partial explanation in compliance with the show cause order issued against her, ARTA Director General Jeremiah Belgica said.

Cirunay is expected to complete the submission of requirements on May 31.

“It’s currently undergoing evaluation by our lawyers and we expect to have a resolution very soon,” Belgica said at the Laging Handa briefing.

The show cause order came after ARTA said it received 23 affidavits of several pharmaceutical companies which detailed the supposed delays committed by the FDA-CDRR on their applications which were filed as far back as 2014.

It directed Cirunay to explain why administrative or criminal cases should not be filed against her.

In a separate statement, ARTA said Cirunay maintained that she and the center’s other staff did their work properly.

Cirunay said that out of the 667 Automatic Renewal applications cited in ARTA’s show cause order, only 412 were actually filed before the drug center as the rest were duplicate applications.

She said the drug center had already processed 331 applications.

ARTA said it would check with the pharmaceutical stakeholders if the permits were indeed released to them.—AOL, GMA News