Darrow JJ - Indiana Law Review
Drawing on Kraakman’s influential framework on third-party gatekeepers in corporate finance, the article applies a gatekeeping analysis to the pharmaceutical marketplace, examining how diverse entities, including the FDA, USPTO, FTC, physicians, insurance companies, and patients, serve as potential gatekeepers against pharmaceutical misconduct. The analysis explores how these federal agencies and private actors, each wielding different powers to withhold support from potentially harmful pharmaceutical practices, can more effectively deter wrongdoing in a complex regulatory landscape.
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Eisenkraft Klein D, Kesselheim AS - Clinical Pharmacology & Therapeutics
Cai CL, Bucha S, Kesselheim AS, Rome BN - Journal of General Internal Medicine
Chen NC, Bullement A, Zemplenyi AT, O'Bryant CL, Kaizer AM, Anderson KE, McQueen RB - PharmacoEconomics Open