BIO Files Amicus Brief in U.S. ex rel. Scutte v. SuperValu Inc. at the Supreme Court of the United States
BIO has filed an amicus brief in U.S. ex rel. Scutte v. SuperValu Inc., which addresses the issue of the intent requirement under the False Claims Act (FCA). Specifically, BIO urges the Court to uphold the view that a firm does not have the requisite intent to violate the FCA when its interpretation of a statute or regulation: (1) is “objectively reasonable,” and (2) no authoritative guidance cautions against it.
A carefully calibrated FCA intent requirement is important to biotech companies, which operate in an environment of extreme regulatory complexity. Federal agencies frequently manage this complexity by pursuing a strategy of deliberate regulatory ambiguity (i.e., relying on non-binding guidance rather than statutory language or rulemaking). Ths approach has a number of advantages, but when coupled with a overly broad FCA intent requirement risks chilling beneficial conduct. In the absence of a sensible intent requirement, biotech companies will tend to adopt only the most conservative regulatory interpretations, resulting in innovation- and investment-stifling overdeterrence, with corresponding implications for access and patient health.
BIO was joined in the brief by AdvaMed and the Medical Information Working Group.