The Federal Trade Commission announced that it has received clearance from the Office of Management and Budget under the Paperwork Reduction Act to conduct a study of U.S. generic drug competition. The study will enable the Commission to provide a more complete picture of how generic drug competition has developed under the Hatch-Waxman Act, which governs the Food and Drug Administration's approval process of generic drugs. The FTC already has taken enforcement action against alleged anticompetitive agreements whose operation depended in part on certain provisions of the Hatch-Waxman Act.
The study will shed light on matters such as whether the agreements the FTC has found are isolated instances or are more typical, and whether particular provisions of the Act have operated appropriately to balance the legitimate interests of pharmaceutical companies in protection of their intellectual property and the legitimate interests of generic companies in providing competition, or have instead unintentionally enabled anticompetitive strategies that delay or deter market entry by generic drugs.
The Commission will soon issue special orders to approximately 100 pharmaceutical companies (30 name-brand manufacturers and 70 generic drug companies) pursuant to Section 6(b) of the FTC Act. The companies will have 60 days to respond to the special orders. The Commission plans to compile the information received to provide a factual description of how the 180-day marketing exclusivity and 30-month stay provisions of the Hatch-Waxman Act have influenced the development of generic drug competition.
Copies of documents related to the study - see press releases dated October 11, 2000 and February 23, 2001- are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; toll-free: 877-FTC-HELP (877-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
Office of Public Affairs