FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

In a highly unusual move, on March 27, the US Food and Drug Administration (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications (NDAs) that relied on bioequivalence studies conducted by Raptim Research Pvt. Ltd, a contract research organization based in Navi Mumbai, India.

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In the Notice, the FDA said it had “identified significant data integrity and study conduct concerns” during inspections of Raptim between 2019 and 2023, leading it to conclude that “Raptim created and caused the submission of falsified in vitro data to the FDA.”

As a result, the Agency took the following actions:

  • Sponsors of NDAs and ANDAs have been notified that in vitro studies conducted by Raptim are not acceptable, and when those studies are or have been essential for approval, they must be repeated at study sites that do not have data integrity concerns.
  • Applications with in vivo studies conducted by Raptim will be handled on a case-by-case basis. Study concerns can be addressed by providing additional information to justify how the data can still be used, re-analyzing the study samples and re-conducting statistical analyses to demonstrate bioequivalence, or conducting new studies.
  • The FDA is changing the therapeutic equivalence rating to “BX” for certain approved and marketed generic drugs that relied on bioequivalence data from Raptim until repeat studies can be submitted. A “BX” rating indicates that the data are insufficient to determine therapeutic equivalence (substitutionality) of the generic product to its brand-name product. FDA is suggesting that patients who use such a “BX” drug consult with their health care provider about continued use.

In addition to the Notice, the FDA released a 20-page “Untitled Letter” outlining objectionable circumstances that the Agency found at Raptim.

For more information, contact the author of this alert or the ArentFox Schiff attorney who handles your matters.

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