FDA investigating alleged data falsification by contract lab
Investigation of data falsification at the contract testing laboratory is one of a number of probes by a US Food and Drug Administration (FDA) anti-fraud programme. Reports a contract research organisation (CRO) falsified documents in pharma-sponsored trials are also being investigated.
Established in 2010 using $1.7m (€1.2m) from the US Department of Heath and Human Services (HHS), the FDA Pharmaceutical Fraud Pilot Program (PFPP) has already opened a number of investigations.
Current PFPP investigations are looking at: alleged trial document falsification by a study coordinator; fraud associated with current good manufacturing practices (cGMP); and three cases related to drug promotion.
Criminal and civil remedies, as well as monetary recoveries, are being pursued with support of FDA Criminal Investigations and the US Office of the General Counsel (OCG). The FDA said it is pursuing “all available criminal and civil remedies to punish and deter” fraudulent conduct.
Detecting and prosecuting biopharm fraud furthers the public health goals of the FDA, helps reduce healthcare costs and deters future violations, according to the 2010 Healthcare Fraud and Abuse Control Program report.
Hiring for the PFPP is underway and the FDA is also tightening collaboration within the agency. As such, the PFPP has initiated investigations based on information from the Center for Drug Evaluation and Research and expects to receive similar leads from the biologics and device units.
The PFPP is also monitoring external sources, such as websites, for indications of fraudulent medical product schemes. Having identified a lead the PFPP is coordinating with criminal investigators, the US Attorney’s Offices and regulatory aspects of the FDA to further the case.
Anti-fraud activities will be supported and expanded through an FDA training programme. For instance, field office supervisors at the US Office of Criminal Investigations (OCI) will be instructed on internal and external aspects of the anti-fraud programme.