Brand name drug companies are increasingly invoking their Risk Evaluation and Mitigation Strategies (REMS) to deny potential generic competitors access to their products. Specifically, branded drug companies have used REMS to deny prospective generic pharmaceutical companies access to critical drug samples. While the FTC has yet to file enforcement actions for invoking REMS to preclude or delay generic competition, it has announced that REMS misuse is an enforcement priority and has filed an amicus brief in private antitrust litigation. Third Circuit courts have also recently weighed in on the issue. This panel, sponsored by the ABA's Section of Antitrust Law and Health Care and Pharmaceuticals Committee, will review those decisions, along with the background of REMS generally, to shed light on some important lessons for antitrust lawyers.
WilmerHale Partner Mark Ford is a featured speaker on this panel.