On Monday, February 22, President Obama put forward a series of health reform proposals leading up to the February 25 bipartisan health care summit. These proposals can be found here. I describe the proposals at length at the Health Affairs blog. Of particular legal interest are the proposals provisions for health care fraud and abuse and for pharmaceutical patent litigation.
The fraud and abuse proposals, drawn both from the President’s 2011 budget and from Republican proposals, would:
The President’s proposal, like the House bill, also addresses “pay for delay” settlements of llitigation between brand-name and generic drug manufacturers designed to keep generics of the market, which the Federal Trade Commission estimates costs consumers $35 billion per decade. The President’s Proposal declares anticompetitive and unlawful any agreement in which a generic drug manufacturer receives anything of value from a brand-name drug manufacturer and in which the generic drug manufacturer agrees to limit or forego research, development, marketing, manufacturing, or sales of the generic drug. This presumption against the legality of the agreement can be overcome only if the parties to such an agreement provide clear and convincing evidence that the procompetitive benefits of the agreement outweigh its anticompetitive effects. The FTC is given authority to enforce the prohibition.
Categories: Legal Issues
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.