IPEC says confusion around FDA review of excipients could delay ANDA review cycles

As a result of the IID issues, IPEC says that pharma companies filing ANDAs have seen longer review cycles, “unnecessary requests​” for additional safety studies/information and/or Refuse to Receive letters from the Agency. 

And what’s adding to the confusion is that many of the ANDA filers have turned to their excipient suppliers for assistance with the FDA deficiency letters, but “the discrepancies in the IID and FDA policies documented in recent draft and final guidance documents limits the ability of  inactive ingredient manufacturers to assist these customers​.”

Recent deficiencies cited by reviewers include requests for complete pharmacology and toxicology data, Refusal to Receive if a different grade of an excipient is used than those listed in the IID, and justification for using ingredients that are GRAS (generally recognized as safe).

“Requirements cited by the Agency are placing inactive ingredient suppliers in a difficult position, since the data requested for these types of inactive ingredients do not exist,” ​IPEC says. “Further, the recent issuance of both the Refuse-To-Receive (RTR) and Controlled Correspondence guidances has created additional confusion in the industry​”

What Needs to Get Done​

IPEC says that industry needs more transparency around the IID to ensure accurate and complete information is captured for reference by both the FDA reviewers and industry.  More specifically, the group seeks quarterly updates to the IID listings, especially as the last quarterly update was posted on October 2013.

IPEC is also seeking more timely communication to industry with regards to the FDA improvement strategies and status of the IID, as we all as a timeline and mechanism for updating inaccurate and incomplete data in the IID.

“It is further critical for both parties to work together to address the inconsistent and conflicting information found in FDA guidance’s (RTR and Controlled Correspondence), which have created additional confusion throughout the industry as they relate to inactive ingredients​,” as the guidance documents, according to IPEC, do “not appear to take into account historically accepted scientific practices, for either the industry or FDA reviews, of inactive ingredient information​.”  

In addition, IPEC-Americas plans to continue to request a committed timeline from the FDA to address these issues.