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FDA Calls for Repeating Clinical and Bioanalytical Studies

Recently, the U.S. Food and Drug Administration (FDA) notified several pharmaceutical companies that they must repeat their clinical and bioanalytical studies conducted by Synchron Research Services (Synchron) or Panexcell Clinical Lab (Panexcell) due to significant data integrity concerns. The data concerns arose from inspections conducted at the facilities of these two Indian clinical research organizations (CROs) in 2019 as well as FDA’s analyses of study data generated at these two CROs that were submitted in several drug applications.

In a notification to industry, the FDA stated that it found “significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA.” The FDA further notified pharmaceutical companies that conducted bioequivalence and bioavailability studies at these two CROs that they must repeat these studies if they are essential for approval. This action applies to all pharmaceutical companies with drugs that have been approved, tentatively approved, or are currently under review by the FDA.

In an “untitled letter” to Panexcell, the FDA wrote that “the manner in which Panexcell conducted the studies noted above causes FDA to believe that the reliability and validity of study data generated by your firm cannot be ensured.” The FDA further asserted that Panexcell is responsible for the “creation of false data in the studies” and determined that “all study data from all studies conducted at your firm must be rejected.” The FDA also issued a similar letter to Synchron detailing its findings at their facility and identifying its concerns related to FDA’s review of data generated at Synchron.  

The FDA has concluded that data from these two CROs are not acceptable to support a determination of safety or effectiveness for brand drugs, or to demonstrate that the affected generic drug products are bioequivalent to the respective brand name drugs. As a result, FDA has changed the therapeutic equivalence rating to “BX” for any approved abbreviated new drugs applications (ANDAs) that relied on study data from Synchron or Panexcell. The new rating of “BX” means that the generic drug products are insufficient for FDA to determine therapeutic equivalence with brand drug products. Although these generic drug products are still approved and can be prescribed, these products are no longer automatically substitutable at the pharmacy.

Based on the FDA’s Questions and Answers Regarding Data Integrity Violations at Panexcell Clinical Lab and Synchron Research Services, the FDA reiterated its stance that affected companies would either have to repeat these studies or will have to voluntarily withdraw their products from the markets. FDA also stated that it will work with Synchron and Panexcell to ensure adequate and corrective actions are developed and implemented.

© 2023 Foley & Lardner LLPNational Law Review, Volume XI, Number 299

About this Author

Devaki Patel Healthcare Lawyer Foley and Lardner

Devaki (Devki) Patel is an associate with Foley & Lardner LLP, based in the firm’s Washington D.C. office, where she is a member of the firm’s Government Solutions and FDA Regulatory Practices. She is also a member of the Life Sciences, Food and Beverage and Cannabis Industry Teams. In addition to being an attorney, she is a licensed pharmacist. Devaki is admitted to practice only in Maryland. She is practicing under the supervision of a member of the District of Columbia Bar.

Prior to joining Foley, Devaki worked for the Food and Drug Administration as a legal intern,...

Kyle Faget, Foley Lardner, Government policy lawyer

Kyle Faget is a Partner and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining...