Fraud and Abuse
Providing items of value to those in a position to prescribe or recommend products that Life Sciences companies sell may implicate significant civil and criminal liability under federal and state anti-kickback laws, as well as treble damages under the Federal False Claims Act. We evaluate risks associated with particular Life Sciences company programs and provide counseling on ways to minimize risk either through compliance with applicable safe harbors or by evaluating advisory opinions to determine how best to structure programs to achieve business objectives without running afoul of the law.
Our subsidiary, Porzio Life Sciences, LLC, offers a database containing searchable summaries of compliance requirements resulting from federal government enforcement actions against Life Sciences companies that have allegedly violateded anti-kickback laws, the Prescription Drug Marketing Act, FDA regulations, and the False Claims Act among others. The database also provides insight into federal government, as well as access to relevant documents, when available.
