2 June 2021 – An office of the Food and Drug Administration (FDA) released hundreds of Automatic Renewal (AR) drug applications from when it received the Anti-Red Tape Authority’s show-cause order on 14 May 2021 until its May 31 deadline.
 
In her explanation as full compliance of the show-cause order, Jesusa Joyce N. Cirunay, Director IV of the FDA Center for Drug Regulation and Research (CDRR), said they have processed 408 out of 412 AR applications.
 
The four remaining applications are pending because two were not submitted by the client while the other two were re-routed to other centers or units, Cirunay explained.
 
Data from the FDA CDRR showed that hundreds of the 408 applications were processed from 14 May 2021, when it received ARTA’s show-cause order and additional affidavits, to 31 May 2021, its final day to reply to the said order.
 
Ambica International Corporation’s application, that was received by the drug center on 2 February 2017, was only approved on 28 May 2021—almost 1,576 days or four years, three months, and 26 days from its date of application.
 
The Authority is now evaluating FDA CDRR’s reply before recommending an appropriate action.
 
ARTA issued a show-cause order to the drug center on May 11 for its alleged inaction on hundreds of AR drug applications from different pharmaceutical companies.
 
This stemmed from ARTA’s receipt of numerous affidavit complaints from various pharmaceutical companies on their pending drug applications before FDA CDRR.
 
Cirunay was given seven working days to explain why no administrative and criminal charges should be filed against her.
 
She was granted a motion for extension until May 31 to fully comply with ARTA’s order.
 
The Authority is calling on the public to submit affidavit complaints if they have any pending applications with other government agencies.
 
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