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Show-cause order issued to FDA over alleged pharma extortion
The order, dated May 10 but sent by ARTA Investigation Enforcement and Litigation director Jedrek Ng yesterday, ordered FDA’s Center for Drug Regulation and Research (CDRR) Director IV Jesusa Cirunay to explain why no administrative or criminal case should be filed against her for the delays committed by the agency on applications received from pharmaceutical firms.
AFP

Show-cause order issued to FDA over alleged pharma extortion

Louella Desiderio (The Philippine Star) - May 12, 2021 - 12:00am

MANILA, Philippines — The Anti-Red Tape Authority (ARTA) has issued a show-cause order to the Food and Drug Administration (FDA) for its alleged inaction on over 600 applications filed by pharmaceutical companies despite having complete requirements.

The order, dated May 10 but sent by ARTA Investigation Enforcement and Litigation director Jedrek Ng yesterday, ordered FDA’s Center for Drug Regulation and Research (CDRR) Director IV Jesusa Cirunay to explain why no administrative or criminal case should be filed against her for the delays committed by the agency on applications received from pharmaceutical firms.

Cirunay was ordered to immediately conduct an inventory of all pending transactions with the office beyond the prescribed processing time stated in the updated citizen’s charter.

ARTA directed Cirunay to release the permits, certifications and clearances for applications with complete requirements and paid fees beyond the prescribed processing time as these are deemed automatically approved or automatically extended under Republic Act 11032 or the Ease of Doing Business and Efficient Government Service Delivery Act.

Cirunay must submit a compliance report within seven days from receipt of the order.

ARTA issued the show cause order based on 23 affidavits of pharmaceutical companies detailing the alleged delays committed by the FDA-CDRR on applications filed as far back as 2014.

“When you look at these applications, these are not complicated. These are applications for automatic renewal. These are products that are already being used and just want to be registered or pose low to no risk to the public,” ARTA director general Jeremiah Belgica said.

“We don’t understand why these are stuck and this always happens with FDA, particularly in the Center for Drugs. These are applications that can be approved by the center director,” Belgica added.

ARTA will file charges against Cirunay before the Office of the Ombudsman if she fails to comply with the order, Belgica said.

Under the law, Belgica said there would be suspension of six months for the first offense and prison term for the second offense.

“If you don’t shape up, you can expect the second phase to be taken by ARTA. We would really go all out because of the backlog in applications,” he said.

Belgica also urged Health Secretary Francisco Duque III and FDA director general Eric Domingo to dismiss erring officials and personnel in the FDA.

Domingo said the FDA has yet to receive a copy of the order, but reiterated that they would cooperate with the ARTA probe.

“There is no room for delays in the registration of drugs, especially once all requirements are submitted,” he said. – Sheila Crisostomo

ARTA FDA
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