REMS Litigation-Key Insights From Government and Private Practitioners
11 AM EDT
Background: 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 will review those decisions, along with the background of REMS generally, to shed light on some important lessons for antitrust lawyers.
FREE: Antitrust Section Members, Government, Non-profit Employees, Students
$25 Other Non-Members
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The ABA is not seeking CLE credit for this program.
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