Abstract
This submission to the FDA explains why patents covering REMS (Risk Evaluation and Mitigation Strategies, applying to risky drugs) programs should not be listed in the Orange Book (which lists drugs and any relevant patents). First, it explains that these patents are not similar to categories listable in the Orange Book. Second, it demonstrates how the listing of REMS patents in the Orange Book harms competition. Third, it shows how these patents undermine the relevant statute. Fourth, it offers a proposal to implement the recommendation.
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