Biotechnology has had a profound impact on pharmaceutical development, perhaps most notably in the fields of cancer, diabetes, HIV/AIDS and autoimmune disorders. Biologics have added major therapeutic options for the treatment of diseases for which effective therapies were either inadequate or nonexistent. As with traditional pharmaceuticals, the Food and Drug Administration struggles to balance the need for biologics that provide significant benefits to patients against their potential for serious side effects.
Last year’s Food and Drug Administration Amendments Act gave the FDA increased authority to require Risk Evaluation and Mitigation Strategies — safety plans similar to those previously known as Risk Minimization Action Plans. In-house counsel should be aware of the relationship between REMS and the claims made in a typical failure to warn or omission-based personal injury or consumer fraud litigation.
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