Been More Real

The Antitrust Risks for Pharmaceutical Manufacturers Have Never Been More Real

The Federal Trade Commission has been persistent in trying to eliminate reverse payment settlements. With increased pressure from regulators, and proposed legislation on Capitol Hill, both brand and generic drug makers must have practical strategies in place that recognize today’s issues. We can anticipate that the Supreme Court will soon be addressing the conflict among the Circuits regarding whether or not reverse settlement payment agreements are per se illegal.

In addition to concern for government enforcement stemming from reverse settlement payment agreements, there are potential pitfalls relating to pricing and distribution tactics and life cycle management. The handling by regulators of recent high-profile mergers and product acquisitions as well as the release of the revised FTC/DOJ horizontal merger guidelines must be factored into future M&A strategies within the pharmaceutical industry. In addition, the creation of a new regulatory pathway for follow-on biologics necessitates that manufacturers keep abreast of how emerging enforcement trends and antitrust analysis will be applied in the context of this developing area. There has also been an increase in private and government-initiated class action litigation arising out of antitrust claims. Counsel for both brand and generic manufacturers are thus facing a fast-changing environment that presents many dangers, and requires implementation of effective new defensive and offensive strategies.

There is now heightened cooperation between the FTC and Global Regulators

Meanwhile on the international front, a closer alignment between the FTC and the European Commission has upped the ante for global regulatory compliance and the industry is the target of increasing focus by the Brazilian authorities.

Now in its 6th installment, American Conference Institute’s Pharmaceutical Antitrust conference is the unique event that industry counsel attend to learn, directly from senior Federal Trade Commission officials and expert practitioners in the field (many formerly at FTC) about current policy initiatives and enforcement and compliance strategies. Featuring a faculty comprised of the leading authorities on antitrust enforcement within the pharmaceutical industry, take advantage of this rare opportunity to hear directly from such leaders as FTC Commissioner J. Thomas Rosch, as well as Richard Feinstein, Director of the Bureau of Competition. Also hear from Satish Sule, member of the Pharmaceuticals Task Force of the European Commission and José Antonio B.M. Ziebarth from Brazil.

Further enhance your expertise by attending the Master Class, “Working with the FTC and Responding to an Investigation.” This very practical workshop will provide a unique inside understanding of how the FTC interacts with companies and offer insights on how to work more effectively with the Commission.

Reserve your space now by calling 888-224-2480, faxing your registration to 877-927-1563, or registering online at www.AmericanConference.com/PharmaAntitrust.

Sponsors:
Jones Day
Morrison Foerster