FDA to cooperate with anti-red tape body on delays in drug applications
MANILA, Philippines — The country’s Food and Drug Administration is already looking for applications said to be pending before its drug testing center after the government's anti-red tape body warned of possible charges for its alleged inaction, the drug regulator’s chief said Wednesday.
FDA Director General Eric Domingo said the agency will cooperate with authorities following the Anti-Red Tape Authority's issuance of a show cause order to the Center for Drug Regulation and Research (CDRR) for supposedly “sitting on” more than 600 drug applications.
ARTA wants CDRR Director Jesusa Cirunay to do an inventory of the pending applications and release them within seven days. If she fails to comply, she may face charges under Republic Act 11032, or the Ease of Doing Business and Efficient Government Service Delivery Act.
“The FDA will cooperate fully with authorities in the investigation to determine if there were problems,” Domingo said in Filipino during an interview with ABS-CBN’s Teleradyo.
“Our legal service office is now helping in tracing the application to see if there were really lapses and if there were also problems that were not acted upon,” he added.
The anti-red tape body said the move stemmed from 23 affidavits of pharmaceutical firms who complained of delays in the processing of their applications filed as far back as 2014.
ARTA’s threat was the latest attempt to push the drug regulator to speed up its processes amid the coronavirus pandemic.
The FDA has been under pressure from several lawmakers who have been pushing for the use of anti-parasitic medication ivermectin for the prevention and treatment of COVID-19 despite insufficient evidence supporting its use for this purpose. Last March, ARTA also asked the FDA to expedite application process for ivermectin.
Domingo admitted to facing pressure but said that this has not affected decisions of the agency. — with report from Xave Gregorio
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