THE Anti-Red Tape Authority (ARTA) has issued a show-cause order to a Food and Drug Administration (FDA) official who allegedly sat on over 600 drug applications filed by various pharmaceutical companies.
ARTA said the order directs FDA Center for Drug Regulation and Research Director Jesusa Cirunay to “explain why no administrative or criminal case should be filed” against her.
The agency said its action was prompted by 23 affidavits from several pharmaceutical companies detailing the alleged delays committed by FDA-CDRR on their applications filed as far back as 2014.
In a statement, the agency said Cirunay has seven working days from receipt of the order to respond.
In a text message, FDA Director General Eric Domingo said they have yet to receive a copy of the ARTA order but assured they are ready to cooperate with the agency.
“The FDA is fully committed to cooperating with ARTA in investigation. There is no room for delay in the registration of drugs especially once all requirements are submitted,” Domingo said. — With Gerard Naval