Arta flags 600+ pending drug applications in FDA

THE Anti-red Tape Authority (Arta) has directed the Food and Drug Administration (FDA) Center for Drug Regulation and Research (CDRR) to immediately address over 600 drug applications that have remained pending despite complete submission of requirements.

In a news statement issued on Tuesday, the anti-red tape watchdog said they have issued a show-cause order to FDA-CDRR Director IV Jesusa Cirunay, which stemmed from 23 affidavits of several pharmaceutical companies alleging the delays on their applications.

Said applications were filed as far back as 2014 or so, Arta noted. The order also instructs Cirunay to “explain why no administrative or criminal case should be filed” against her.

Arta Director General Jeremiah Belgica explained these applications are not complicated in nature as these are for automatic renewal.

These products, he said, have been previously consumed or only have low to no risk when used.

With this, Cirunay is given seven working days from receipt of the order to do an inventory of all pending permits, license, clearance or application.

She was also told to immediately release all said applications which have been pending beyond the prescribed processing time.

In addition, Arta ordered Cirunay to submit a compliance report with a list of all permits, license, clearance or application issued in accordance with the show-cause order.

Arta shall be filing formal charges against Cirunay before the Office of the Ombudsman should she fail to comply with the order. This is in line with the implementation of Republic Act 11032 or the Ease of Doing Business (EODB) and Efficient Government Service Delivery law, the anti-red tape agency said.

First-time offenders will be meted with a six-month suspension, Belgica noted, while two-time violators will be facing imprisonment.

“We have spoken to you so many times and now there is really a time for everything and a time for reckoning,” he added.

Belgica also urged Health Secretary Francisco Duque III and FDA Director General Eric Domingo to remove, if necessary, the officials and personnel who fail to comply with the EODB law.