PhRMA and DOJ Go Back and Forth Over Off-Label Speech and the First Amendment

A whistleblower’s False Claims Act (FCA) suit in the Eastern District of California has caught the attention of the Pharmaceutical Research and Manufacturers of America (PhRMA) and subsequently the Department of Justice, both of whom have filed amicus curiae briefs in the federal court. PhRMA re-responded to DOJ just last week, underscoring the case's importance. See that response here: PhRMA-Brief-Solis-v-Millennium.  Whistleblower Complaint Frank Solis, a former sales rep at Schering-Plough (now part of Merck) and Millennium Pharmaceuticals, alleged that the two manufacturers illegally marketed the heart medication Integrilin for unapproved off-label uses in violation of the Federal Food, Drug, and Cosmetic (FDCA). Had the government known that the companies "caused procurement for Integrilin for off-label uses," they "would not have provided reimbursement for such prescriptions,” the complaint states. “This course of conduct violates the False Claims Act.” Notably, the government did not join in the case. This did not stop the whistleblower from moving forward, which has been a trend lately with relators who are winning cases after the government declines to intervene.  The defendants responded that off-label speech does not equate to a violation of the FCA. Because Medicare and Medicaid recognize that off-label uses are often medically appropriate and fully reimbursable, the defendants argue, Solis incorrectly conflated all off-...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs