Antitrust Abuses and the FDA Approval Process: Statement Before the Committee on the Judiciary's Subcommittee on Regulatory Reform, Commercial, and Antitrust Law U.S. House of Representatives

Abstract

Various scholars and policymakers have voiced concern over the years that pharmaceutical companies often operate in ways that are inconsistent with norms of fair competition and may violate antitrust law — in particular that, despite complying with the regulatory framework and the intellectual property framework, these companies invoke or employ these frameworks inappropriately. I was asked by subcommittee staff to provide my perspective on three aspects of the regulatory paradigm of particular interest: citizen petitions, use and distribution restrictions, and FDA’s unapproved drugs initiative.

The written statement concludes with a page of concrete recommendations, which reflect four core values. The first value is the public health mandate embodied in FDA’s statutory mission: promotion of the public health through prompt and efficient review of clinical research and timely appropriate action on marketing of regulated products, and protection of the public health by ensuring that drugs are safe and effective. The second value is the open government principle embodied in the petition clause of the First Amendment, the agency’s mission statement, the APA, and other federal statutes: transparency, access, and accountability. The third value is the importance of the patent property right to continued innovation in medicine, and the final value is the importance of evidence-based policymaking, both in the legislature and in administrative agencies.

Keywords: FDA, Patent, Antitrust, Drug Pricing, Generic Drugs, Public Health, Transparency, Open Government