Risk Evaluation and Mitigation Strategies (REMS): Balancing Brand Justifications and the Proper Role of Antitrust Enforcers

webinar
19 November 2014
Hosted By: the Healthcare and Pharmaceuticals and Federal Civil Enforcement Committees of the ABA Section of Antitrust Law

Risk Evaluation and Mitigation Strategies (REMS) are designed to ensure the safe distribution of drugs; however, according to a recent report from the Generic Pharmaceutical Association, REMS may be costing the American health care system $5.4 billion in annual pharmaceutical spending. This panel, held by the Healthcare and Pharmaceuticals and Federal Civil Enforcement Committees of the ABA Section of Antitrust Law on 19 November 2014, examined a number of important questions surrounding the use of REMS. The panel featured NERA Senior Vice President Dr. Christine Meyer, as well as Jan Rybnicek, Advisor to FTC Commissioner Joshua Wright; Richard A. Feinstein, Partner, Boies Schiller & Flexner LLP; and Alex Brill, CEO, Matrix Global Advisors. Together they discussed whether brand manufacturers have valid justifications for restricting distribution; how the courts should balance potential efficiencies of such behavior against potential anticompetitive effects; and the role of antitrust enforcers in examining and litigating REMS practices. The panel was moderated by Robert Davis, Counsel, Venable LLP.

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