Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.

Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

Persistent data integrity and quality unit failures at two Apotex plants in Bangalore, India, led to wholesale US market withdrawals by the Canadian generic drug manufacturer.