Regulating Innovative Medicine: Fitting Square Pegs in Round Holes

By: Mark Lavender

Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration (“FDA”) because they often transcend the FDA’s traditional categorical approach to regulating medical products. In a recent attempt to simplify this process, the FDA has proposed a new rule for regulating “combination products.” This iBrief discusses the FDA’s current approach and analyzes the possible affects of the proposed regulation. Because of the many shortcomings of both systems, this iBrief concludes that the FDA should instead stop assigning center jurisdiction based on a product’s “primary mode of action,” and give the Office of Combination Products internal agency jurisdiction over combination products. This alternative approach would increase consistency and efficiency while maintaining the FDA’s high standards for medical product safety and efficacy.

Cite: 2005 Duke L. & Tech. Rev. 0001

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