Abstract
This Article provides an antitrust and economic analysis of a refusal-to-deal claim in the REMS context. The analysis suggests that the antitrust claims involved do not provide a proper justification for a new exception to a competitor’s right to refuse to deal. The FDA and Congress play important roles in the complex regulatory scheme of the U.S. pharmaceutical industry. With so much regulation and oversight, antitrust has little place in ensuring an efficiently functioning market for REMS-restricted pharmaceuticals.
Part I provides background about generic drug entry under the Hatch-Waxman Act, which lays out the framework for ANDAs, and discusses REMS-restricted drugs under the FDAAA. This Part also details current antitrust litigation stemming from refusal to deal in the REMS context, as well as the FTC’s position on such conduct. Part II summarizes the antitrust refusal-to-deal doctrine under section 2 of the Sherman Act by analyzing prior U.S. Supreme Court precedent. This Part then argues that refusal-to-deal claims in the REMS context fail under current refusal-to-deal jurisprudence. Part III argues that given the error costs associated with antitrust or agency intervention, such intervention would be contrary to public policy. Part IV suggests a narrow antitrust framework to analyze refusal to deal in the REMS context if the courts determine that antitrust analysis is appropriate. If the refusal to provide samples of REMS-restricted drugs to competitors does receive antitrust scrutiny, it should be evaluated under the profit-sacrifice test. Analysis under other theories of antitrust liability would be imprudent.
Recommended Citation
Henry N. Butler,
REMS-Restricted Drug Distribution Programs and the Antitrust Economics of Refusals to Deal with Potential General Competitors,
67 Fla. L. Rev.
977
(2015).
Available at: https://scholarship.law.ufl.edu/flr/vol67/iss3/1