No Moral Price: Leveraging Bayh-Dole to Uncover the True Cost of Innovation

By Fabiha Khan

Federal regulators’ inability to access drug-specific research and development (“R&D”) costs constitutes a pressing issue requiring careful scrutiny.  The absence of this data impairs regulatory solutions addressing extreme drug prices and leaves uncontested one of the most effective arguments that the pharmaceutical industry wields to ward off pricing regulation: the purported “chill to innovation.”  Rigorous evaluation of these statistics is essential to determining how to best structure drug prices to facilitate innovation.  This Note presents a novel mechanism for acquiring this crucial information: the Bayh-Dole Act’s “march-in” provision.  This thus-far unused legislative provision endows certain federal agencies with the authority to fact-find.  This Note asserts that the government should leverage this investigative function to obtain drug-specific R&D data, an endeavor that would significantly aid the creation of reasonable pricing benchmarks while sidestepping the risks associated with fully exercising march-in rights.  This Note demonstrates the technical, political, and legal feasibility of this endeavor by analyzing relevant regulations, statutes, case law, and recent political developments.  Americans have been forced to navigate the pharmaceutical realm at an informational handicap for long enough; it is time to level the playing field.

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