Removing Obstacles to Generic Drug Competition: A Critical Priority for Health Care Reform

Posted by D. Daniel Sokol

Along with holding Chairman Leibowitz's speech on exclusion payments yesterday, the Center for American Progress released a paper on pharmaceutical antitrust enforcement by David Balto titled Removing Obstacles to Generic Drug Competition: A Critical Priority for Health Care Reform.

ABSTRACT: The paper focuses on a variety of potential anticompetitive conduct including exclusion payments, product hopping, authorized generics, and sham regulatory filings and recommends that:

• Congress should pass legislation expressly prohibiting exclusion payments in patent settlements
• The Federal Trade Commission should investigate and bring cases to challenge product hopping where it has anticompetitive effects
• Congress should enact a ban on authorized generics and the Federal Trade Commission should bring cases to prevent their use
• The Federal Trade Commission should investigate and challenge the use of sham regulatory filings, such as citizen petitions and other efforts to subvert the regulatory process.