FDA looking into alleged delays in drug applications
MANILA, Philippines — The Food and Drug Administration (FDA) is now looking into the alleged inaction of one of its offices on more than 600 drug applications of various pharmaceutical companies.
FDA Director General Eric Domingo made the remark Wednesday after the Anti-Red Tape Authority (ARTA) issued a show-cause order against FDA Center for Drug Regulation and Research (CDRR) Director IV Jesusa Joyce Cirunay asking her to explain why no administrative or criminal case should be filed against her over the alleged delays in processing the applications.
“‘Yung aming legal service namin ngayon ay tumutulong na rin na i-trace itong mga applications na ito para malaman kung may pagkukulang man o may problema talaga at hindi naaaksyunan,” Domingo said in an interview with Teleradyo.
(Our legal service office is now helping in tracing the applications to see if the applications were incomplete or there were problems that were not acted on.)
Domingo said that when he assumed office, there were already backlogs in drug applications of pharmaceutical companies.
Nonetheless, Domingo said the FDA will coordinate with authorities regarding the matter.
“Ang FDA will cooperate fully with the authorities sa pag-investigate nito para makita natin kung mayroon ngang problema,” Domingo said.
(The FDA will fully cooperate with authorities in the investigation so that we can see if there were problems.)
The show cause order stemmed from the 23 affidavits of several pharmaceutical companies detailing the alleged delays committed by FDA-CDRR on their applications filed as far back as 2014.
“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 ng 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.
(The applications were not complicated. These were the applications for automatic renewal. These are the products that were being used before and they just want to register it. Some are also low to no risk to the public.)
“Di namin maintidihan kung bakit ito ay naiipit at ito ay palagi na nangyayari diyan sa FDA particularly sa Center for Drugs. Ito ay mga aplikasyon na pwedeng aprubahan ng Center Director,” he added.
(We do not understand why these are being stalled in the FDA particularly the Center for Drugs. These applications can be approved by the Center Director.)
Cirunay is given seven working days from receipt of the show cause order to conduct an inventory of all pending permit, license, clearance or application; immediately release all said applications which have been pending beyond the prescribed processing time; and submit to ARTA a compliance report.
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