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?
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)
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
Defining “Payments”: The First Post-Actavis Battleground in Pharmaceutical Reverse Payments
This broad interpretation of the scope of Actavis will likely prove to be a “boon” for economic litigation consulting firms. Lauren Battaglia (Hogan Lovells)
New Jersey District Court Limits Actavis To Cash Payments
The Lamictal decision establishes a potential bright-line rule exempting from antitrust scrutiny most patent settlements involving the transfer of only noncash benefits. Donald Falk & Christopher Kelly (Mayer Brown)
Courts’ Prescription for Reverse-Payment Settlements Still Unknown Almost a Year After FTC v. Actavis
Much if not virtually all of the guidance on the antitrust analysis of reverse-payment settlements is being left to the district courts. Ankur Kapoor & Rosa Morales (Constantine Cannon)
The St. Luke’ s-Saltzer Antitrust Case: Can Antitrust and Health Care Reform Policies Converge?
The extent to which ownership is superior to looser affiliations in facilitating achievement of the goal of delivering higher value care through greater provider coordination was the key issue of this litigation. Monica Noether (CRAI)
North Carolina Dental: The Supreme Court and State Action Antitrust Immunity
In deciding to grant certiorari, the Supreme Court may have determined that a circuit split exists and that it is ripe for resolution. Jane E. Willis & Amy D. Paul (Ropes & Gray)