Pharmaceutical Agreement Notification Filing Requirements

The Federal Trade Commission has published a notice describing the types of agreements that brand-name pharmaceutical and generic drug manufacturers must file with the FTC and the U.S. Department of Justice (DOJ), pursuant to Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Generally, agreements between brand-name and generic pharmaceutical companies regarding the manufacture, marketing, and sale of generic versions of brand-name drug products are required to be filed with the Commission and DOJ. In addition, certain agreements between generic drug manufacturers, each of which have filed certain types of applications with the U.S. Food and Drug Administration for the same brand-name drug product, must also be filed. These filing requirements cover agreements executed on or after January 7, 2004.

These filing requirements follow the Commission’s recommendation in its July 2002 study, “Generic Drug Entry Prior to Patent Expiration,” that the Commission be notified about the execution of these types of agreements. That recommendation was premised on the fact that the agreements between brand-name and generic drug companies uncovered by the FTC study had the potential anticompetitive effect of delaying generic drug entry. (Staff contact is Michael Wroblewski, 202-326-2155).

Copies of the documents mentioned in this release 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, DC 20580. Call toll-free: 1-877-FTC-HELP.