ARTA slaps FDA office with show-cause order for inaction on over 600 applications

The Anti-Red Tape Authority (ARTA) on Tuesday said it slapped a show-cause order to an office of the Food and Drug Administration (FDA) for its inaction on over 600 drug applications, some of which have been pending for over six years.

In the order dated May 10, ARTA directed FDA Center for Drug Regulation and Research (CDRR) Director IV Jesusa Cirunay to explain why administrative or criminal cases should not be filed against her.

Cirunay was given seven working days from receipt of the order to conduct an inventory of all pending permits, licenses, clearances, or applications.

The FDA official was likewise mandated to immediately release all pending applications and submit a compliance report to ARTA of all permits, licenses, clearances, or applications issued pursuant to the show cause order.

The order comes after the 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.

Under the Ease of Doing Business Act, government agencies should only take three days to process simple transactions, seven days for complex transactions, and 20 days for highly technical transactions.

Quasi-judicial functions of constitutional commissions are not covered by the 3-7-20 rule, but their administrative and frontline services remain covered by the Ease of Doing Business Law.

"'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 nang 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 in a statement.

"'Di namin maintindihan kung bakit ito ay naiipit at ito ay palagi na nagyayari diyan sa FDA particularly sa Center for Drugs. Ito ay mga aplikasyon na puwedeng aprubahan ng Center Director," he added.

(When we look at the applications, these are not complicated and are actually for automatic renewal. These are products that have been in circulation but are for registration, or some are low to no risk for the public.)

(We do not understand why these applications are still pending. This is a usual occurrence in the FDA, particularly for the Center for Drugs. These applications can be approved by the Center Director.)

The ARTA has implemented a two-strike policy for government officials and employees who violate the Ease of Doing Business Act. The first offense entails administrative liability with a six-month suspension, while the second offense entails administrative and criminal liabilities.

Belgica noted that with 600 pending applications, the penalties to be imposed are no joke should FDA officials be charged.

"Kaya 'wag ho kayong makipagbiruan kasi baka akala ho kasi ninyo wala hong ngipin itong batas na 'to. Kung hindi ninyo aayusin 'yan, I would lay down itong nalalabing oras namin dito sa ARTA to make sure na pananagutin ho namin 'yung mga taong nagpapatagal diyan," he said.

(We are not joking, if you think the law has no teeth. If you do not fix this, I would lay down our remaining time in ARTA to make sure that those sitting on applications are found liable).

For its part, the FDA said it will coordinate with the ARTA to address the pending applications.

"The FDA is fully committed to cooperating with ARTA in the investigation. The registration of drugs should not be delayed once requirements are submitted," FDA director general Eric Domingo said in a text message to GMA News Online.

As a regulatory agency under the Department of Health (DOH), the FDA is mandated to ensure the safety, efficacy, or quality of health products.

This includes food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household or urban hazardous substances such as pesticides and toys, or consumer products that may have an effect on health which require regulations.—AOL, GMA News