The Anti-Red Tape Authority (ARTA) is now reviewing the initial response of an officer of the Food and Drug Administration (FDA) to a show-cause order issued against her for allegedly sitting on hundreds of automatic renewal (AR) drug applications.
Jesusa Joyce N. Cirunay, Director IV of the FDA Center for Drug Regulation and Research (CDRR), sent ARTA an explanation on May 24 in partial compliance of the show-cause order after she was granted a motion for extension. She is expected to complete the submission of requirements on May 31.
ARTA Secretary Jeremiah Belgica again warned FDA CDRR to not delay the AR drug applications of pharmaceutical companies that have complete documents.
“Medyo iba po ‘yung sinasabi sa amin doon sa sinasabi ng industriya. May mga affidavits dito,” he said in an interview over DWIZ on Thursday (May 27).
“Malaki po ang epekto nito sa atin, sa taumbayan,” he added. “Pinag-aantay ang taumbayan ngayon sa isang aplikasyon na tama naman… huwag po natin abusuhin ang oras ng tao.”
Should ARTA not be satisfied with Cirunay’s explanation, it may file administrative or criminal charges against her.
In her explanation, Cirunay called the pharmaceutical companies’ complaints against her “devoid of legal and factual bases” and maintained that she and the center’s other staff did their work properly.
She explained that out of the 667 AR applications cited in ARTA’s show-cause order, only 412 were actually filed before the drug center as the rest were duplicate applications.
Of the said figure, the drug center has processed at least 331 applications, she said. ARTA said it will verify with the pharmaceutical stakeholders if the permits were indeed released to them.
Cirunay, who assumed her position in June 2020, said the FDA drug center is combing through its backlog of 13,797 applications from its previous administration.
Despite the supposed lack of manpower and the working limitations brought by the COVID-19 pandemic, she said they have already released 12,028 applications which include 4,942 new applications.
Belgica said this is no excuse to delay the approval of the drug applications because she had nearly a year to finish them.
The FDA CDRR launched the Automatic Renewal eServices Platform, an electronic tool that will facilitate and streamline the processing of drug applications.
But as it is still under development, all drug applications are manually typed, printed, and signed, making the processing time as long as 20 working days.
ARTA issued a show-cause order against FDA CDDR on May 11, directing Cirunay to explain why no charges should be filed against her.
She was given seven working days to reply to the show-cause order. (ARTA) -jlo
