Featured Expert Column: Antitrust & Competition Policy — Federal Trade Commission
By M. Sean Royall, a Partner with Gibson, Dunn & Crutcher LLP, with Richard H. Cunningham, Of Counsel in the firm’s Denver, CO office, and Abiel Garcia, an Associate Attorney in the firm’s Los Angeles, CA office.
On November 8, 2017, the Federal Trade Commission hosted a workshop examining competitive dynamics in the pharmaceutical sector. Participants in the workshop included professors Michael A. Carrier, Aaron Kesselheim, Stephen Schondelmeyer, Neeraj Sood, Erin Fox, and Rena Conti; representatives from industry interest groups Mark Merritt and Todd Ebert; consumer advocate David Mitchell; economists Adam Fein and Hal Singer; FDA Commissioner Dr. Scott Gottlieb; and FTC Acting Chairman Maureen Ohlhausen.
While FTC workshops are informal and have no binding effect on the policies of the agency, they frequently foreshadow areas of future investigative or enforcement focus. Participants’ comments generally affirmed that areas of long-standing FTC activity in the pharmaceutical sector, including reverse payments and merger enforcement, are likely to remain areas of ongoing focus. Two notable new issues also emerged: scrutiny of the industry’s distribution system and potential abuse of FDA regulatory processes to inhibit generic entry. In addition, Dr. Gottlieb announced three new FDA initiatives to facilitate generic entry into pharmaceutical markets. Continue reading “FTC Pharma Workshop Focuses on Supply Chain Issues and “Gamesmanship” of FDA Regulation”