By Pearl Gumapos
Food and Drug Administration (FDA) Director-General Eric Domingo on Wednesday (May 12) said the FDA Center for Drug Regulation and Research (FDA-CDRR) director issued a show-cause order by the Anti-Red Tape Authority (ARTA) has the right to explain herself.
ARTA on Tuesday issued a show-cause order against FDA-CDRR Director IV Jesusa Cirunay for allegedly not acting on more than 600 drug applications submitted by pharmaceutical companies.
According to ARTA, the order directs the FDA officer to “explain why no administrative or criminal case should be filed” against her.
ARTA’s cause of action came from 23 affidavits submitted by several pharmaceutical companies complaining about the delays committed by the FDA-CDRR on their applications that were filed as early as 2014.
“Hinihintay rin naman po natin ‘yung explanation. Mayroon namang karapatang mag-explain ang ating mga workers and officials dito at tapusin ang kanilang trabaho sa pinakamabilis na panahon,” Domingo said in an interview with PTV.
Meanwhile, Domingo said the FDA-CDRR and the FDA’s legal office have been directed to track the applications.
“Iniutos na natin sa Center for Drugs and sa Legal Office ng FDA na i-track po ‘yung mga application na ‘yan, dahil mayroon naman po talagang kaukulang araw kung kailan dapat mabigyan ng resolution ang isang application, at hindi po talaga dapat nabibinbin,” he said.
Domingo said while the COVID-19 situation has made work difficult for the FDA, complaints must still be addressed and resolved.
“Of course sa FDA, we always comply and cooperate with any investigation pagdating sa pagseserbisyo natin sa publiko,” Domingo said.
The FDA chief said the agency has only 1,000 workers who go through many types of applications, from manufacturers to products. However, despite a huge workload and being understaffed, the quality of their work is still a priority, Domingo said.
“But kahit naman po ganoon, kahit kami ay hirap na hirap at pagod na pagod lalo na ngayong panahon ng COVID, na napakarami pong bagong produkto na dapat makarating sa ating bansa, hindi naman po namin pinababayaan ang trabaho namin,” he said.
Domingo added that safety and quality are still their number one concerns. He said that around 250,000 items are registered with the FDA, and that all of the product applications undergo a thorough review before the products are released to the public.
“Hindi talaga kami pumapayag na magamit at maibenta sa labas ang mga produktong hindi tayo sigurado, kaya huwag po kayong mag-alala,” he said.
He assured the public that “safety and quality” come first as the FDA puts through the proper process all the products submitted to it for registration. -jlo