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Full-Text Articles in Law
A Modest Proposal: Leveraging Private Enforcement Mechanisms And The Bayh-Dole Act To Reduce Drug Prices In The U.S. Healthcare Industry, Brittany Day
Duke Journal of Constitutional Law & Public Policy Sidebar
The United States healthcare system is one of the most expensive in the world. Unlike other products, when drug prices skyrocket, people may die. While advocating for various solutions, both the Biden and Trump administrations have recognized the importance of halting the rise of prescription drug prices. Most of the solutions advanced are focused on government-side initiatives, such as allowing Medicare to directly negotiate with pharmaceutical companies. Yet, the "march-in rights" built into the Bayh-Dole Act create an opportunity to set up a mechanism that would invite private actors to sue pharmaceutical companies for unconscionable drug pricing. The Bayh-Dole Act …
Sometimes The Silence Can Be Like The Thunder: Access To Pharmaceutical Data At The Fda, Peter Lurie, Allison Zieve
Sometimes The Silence Can Be Like The Thunder: Access To Pharmaceutical Data At The Fda, Peter Lurie, Allison Zieve
Law and Contemporary Problems
Those committed to the free exchange of scientific information have long complained about various restrictions on access to the FDA's pharmaceutical data and the resultant restrictions on open discourse. A review of open-government procedures and litigation at the FDA demonstrates that the need for transparency at the agency extend well beyond the reach of any clinical trial registry.
Transparency And Innuendo: An Alternative To Reactive Over-Disclosure, Scott M. Lassman
Transparency And Innuendo: An Alternative To Reactive Over-Disclosure, Scott M. Lassman
Law and Contemporary Problems
Lassman examines the tension between transparency and other public health interests in the context of the FDA's proposed Drug Watch web site. He argues that although the FDA proposal seeks to achieve a laudable goal--the prompt communication of important useful safety information about drug products to physicians and patients-- it fails to properly balance transparency and other legitimate public health interests.