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Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina Jan 2021

Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina

Scholarship@WashULaw

State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …


Chief Justice Robert's Individual Mandate: The Lawless Medicine Of Nfib V. Sebelius, Gregory P. Magarian Jan 2013

Chief Justice Robert's Individual Mandate: The Lawless Medicine Of Nfib V. Sebelius, Gregory P. Magarian

Scholarship@WashULaw

After the U.S. Supreme Court in National Federation of Independent Business v. Sebelius held nearly all of the Patient Protection and Affordable Care Act constitutional, praise rained down on Chief Justice John Roberts. The Chief Justice’s lead opinion broke with his usual conservative allies on the Court by upholding the Act’s individual mandate under the Taxing Clause. Numerous academic and popular commentators have lauded the Chief Justice for his political courage and institutional pragmatism. In this essay, Professor Magarian challenges the heroic narrative surrounding the Chief Justice’s opinion. The essay contends that the opinion is, in two distinct senses, fundamentally …