Article: Competitive Edge: New Law Requires Pharmaceutical Companies to Notify Agreements With the U.S. Antitrust Regulators.

By Joel R. Grosberg and Nicholas R. Koberstei

The U.S. Federal Trade Commission (FTC) published a notice that, effective January 7, 2004, pharmaceutical companies must now file certain agreements with the FTC and the U.S. Department of Justice (DOJ) within 10 business days of the execution of the agreement. This new law, which is part of Title XI of the Medicare Prescription Drug, Improvement and Modernization Act of 2003, establishes a new mandatory notification process for certain agreements between brand-name and generic pharmaceutical companies active in the U.S.

The new law requires pharmaceutical companies to file two categories of agreements with ...

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