APR-14(2)

In this issue:

This issue looks at four health issues recently argued by the FTC. First we deal with the FDA’s REMS program and how it seems to conflict with the FTC’s desire to encourage generic competition. Then we present an indepth look, with three analyses, at the N.J. decision that Actavis applies only to cash settlements, which is then followed by discussions of the FTC’s victory in the St. Luke’s physician merger decision and the FTC’s action in North Carolina Dental (dealing with state action doctrine)—a case picked up by SCOTUS. We haven’t heard the last of any of these, so understanding them now is vital.

The FDA’s REMS program – Does the Sherman Act Apply?

Jan Rybnicek, Apr 29, 2014

When Does Sharing Make Sense?: Antitrust & Risk Evaluation and Mitigation Strategies

So when do the antitrust laws require a monopolist to assist a rival? Jan M. Rybnicek (U.S. FTC)

Robert Maness, Brian Segers, Apr 29, 2014

Refusal to Deal Under FDA Imposed Risk Evaluation and Mitigation Strategies (REMS): Economic Considerations

Evidence indicates that some product innovations that have been introduced to the market would likely not have existed but for the restrictive distribution mechanisms that REMS protocols instituted. Robert Maness & Brian Segers (CRAI).

The FTC & Recent Healthcare Decisions

Lauren Battaglia, Apr 29, 2014

Defining “Payments”: The First Post-Actavis Battleground in Pharmaceutical Reverse Payments

This broad interpreta

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