The FDA is not holding punches against India-based CRO Synapse, saying that studies conducted by the group are “unacceptable” due to data integrity issues and should not be used by pharma sponsors.
The agency said in a notification to pharma companies posted Tuesday that any studies conducted by the group would need to be redone. The public lambasting comes more than four months after the FDA first raised concerns to the company about data discrepancies.
The FDA said it sent a letter to Synapse in February outlining “significant data integrity concerns for bioequivalence studies” that were used to support generic drug applications.
In an attempt to hammer the message home, the FDA sent a second letter to the company determining that all study data “must be rejected.”
“FDA is requiring sponsors of approved, tentatively approved or pending ANDAs and NDAs to repeat the bioavailability/bioequivalence studies, when those studies are essential for approval, using an entity other than Synapse or any other organization with known unresolved data integrity concerns,” the agency wrote.
Any approved or marketed generics that relied on Synapse-run trial data are now being marked as “BX,” meaning the data are insufficient to prove therapeutic equivalence. Those drugs will remain approved and can be prescribed, but the FDA no longer stands behind them as proper substitutes for a brand-name drugs.
Synapse did not respond to a request for comment sent to the company’s general inbox.
In a June 17 letter to Synapse, the FDA reiterated that it found multiple study subjects with “nearly identical data” across five studies. The findings raised red flags, forcing the agency to conclude that it didn’t seem possible that the results came from healthy volunteers “by chance.”
The FDA’s full-throated rebuke follows a similar conclusion from its European counterpart.
In December 2023, the European Medicines Agency recommended suspending a number of medicines that were tested by Synapse. The list of medicines that drew EMA concern included products produced by Baxter, Sandoz and Viatris. The companies did not immediately respond to a request for comment.
That decision is being re-examined at the request of the sponsors, with the EMA awaiting a final recommendation. The European agency originally said that listed products needed to provide alternative data to prove bioequivalence.
“Medicines for which ongoing marketing authorisation applications rely solely on data from Synapse Labs will not be granted authorisation in the EU,” the EMA wrote.
Editor’s note: This story was updated to reflect that the FDA’s alert was posted on Tuesday.