FDA asks pharmas to repeat studies done at 2 Indian CROs due to data integrity issues

U.S. FDA
The FDA sent a letter to two Indian CROs last week with findings of data integrity issues that spurred the regulator to ask biopharmas to reconduct studies previously done at the facilities. (syahrir maulana/iStock/Getty Images Plus)

The FDA is asking multiple biopharmas to redo studies they had conducted at Synchron Research Services and Panexcell Clinical Lab because of data integrity concerns that arose during inspections.

The data concerns arose from inspections conducted at the clinical research organizations' facilities in India in November 2019 as well as FDA analyses of study data generated by the CROs that were used in "several applications." 

"FDA has determined that data from Synchron or Panexcell are not acceptable to support a determination of safety or effectiveness for brand name drugs, or to show affected generic products are bioequivalent to brand name products," the FDA said in its notification to pharmas Sept. 16. 

Names of the specific biopharmas affected and details of the studies in question were redacted from the FDA's letters to the two CROs. 

RELATED: Reactions to poor practices, 'Dateline' special on CROs differ in India

Synchron and Panexcell violated federal regulations and submitted invalid study data to the FDA. The regulatory agency notified biopharmas that conducted clinical trials and studies at the two CROs that they must redo the bioequivalence/bioavailability studies "when those studies are essential for approval."

"This action is part of our continued vigilance and commitment to data integrity and protecting consumers from products that may put them at risk. In this case, while approved drugs were impacted, affected applications were also successfully identified while still under review by the agency," Jeremy Kahn, an FDA spokesperson, said in an email to Fierce Biotech. 

Panexcell conducts studies across oncology, endocrinology, dermatology and orthopedics, according to its website. Synchron's website was down as of publication.