The U.S. Court of Appeals for the Eleventh Circuit this week issued a decision that restricts the use of the federal False Claims Act (FCA) as a tool for suppressing truthful speech about off-label uses of medical products approved by the Food and Drug Administration (FDA).
The court’s dismissal of the case U.S.ex rel Hopper v. Solvay Pharmaceuticals, Inc. was a victory for the Washington Legal Foundation (WLF), which had filed a brief urging dismissal of the FCA claim.
The Court ruled that “absence of specific factual allegations that a drug manufacturer took steps to encourage others to seek federal reimbursement for drug costs the manufacturer knew were not reimbursable, a complaint is subject to dismissal.” In noting such a requirement, the Court dismissed U.S. ex rel Hopper v. Solvay Pharmaceuticals, Inc., because the “plaintiff had failed to identify with specificity a single instance in which a doctor or pharmacist sought federal Medicaid or Medicare reimbursement for the drugs they provided to patients.”
WLF noted that if such lawsuits were allowed to proceed, the impact would “harm public health by reducing public knowledge regarding beneficial off-label uses of FDA-approved products.”
Ultimately, ensuring that U.S. physicians continue to have the ability to prescribe patients whatever medicine they deem appropriate based on their experience is crucial.
When research shows that a particular drug that is developed for one purpose can be used for another, physicians should be able to use such information to prescribe that drug for whatever condition they know from experience it will treat.
While FDA regulations prohibit companies from marketing off-label uses, this was not the issue in this case. Instead, this case will allow physicians to continue using research and information about the off-label use of drugs to treat patients.