Search Results - "Sachs, Rachel E"

The accidental innovation policymakers by Sachs, Rachel E

“…Health care policymakers in the United States, particularly at the federal level, have recently considered a range of proposals that would lower prices for…”
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Judge Posner’s Reconstruction of Property Theory by Sachs, Rachel E.

“…The many other terrific contributions to this Symposium analyze clearly and thoughtfully the impact Judge Posner's judicial opinions have had on a wide range…”
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THE UNEASY CASE FOR PATENT LAW by Sachs, Rachel E.

“…A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is Pharmaceuticals. Patents are…”
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The Medicare innovation subsidy by Lemley, Mark A, Ouellette, Lisa Larrimore, Sachs, Rachel E

“…Policymakers on both ends of the political spectrum have been looking for ways to reduce prescription drug prices. Democrats have also been working on…”
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Step Therapy’s Balancing Act — Protecting Patients while Addressing High Drug Prices by Sachs, Rachel E., Kyle, Michael Anne

“…The debate regarding step therapy reflects a tension between two important policy goals: safeguarding patients’ access to high-quality care and constraining…”
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Medicare Coverage of Aducanumab — Implications for State Budgets by Sachs, Rachel E, Bagley, Nicholas

“…CMS is considering whether and under what circumstances Medicare will pay for aducanumab for Alzheimer’s disease. A restrictive coverage determination could…”
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The Rhetorical Transformations and Policy Failures of Prescription Drug Pricing Reform under the Trump Administration by Sachs, Rachel E

“…Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language…”
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Supreme Power — The Loss of Judicial Deference to Health Agencies by Sachs, Rachel E., Fuse Brown, Erin C.

“…The Supreme Court’s decision in Loper Bright Enterprises v. Raimondo could open the door to more, and broader, challenges to actions taken by health agencies…”
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Importing Prescription Drugs from Canada — Legal and Practical Problems with the Trump Administration’s Proposal by Sachs, Rachel E, Bagley, Nicholas

“…The Trump administration has proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada…”
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Preapproval Promises to Voluntarily Withdraw FDA-Approved Drugs by Fernandez Lynch, Holly, Sachs, Rachel E

“…This Viewpoint provides recommendations for improvements to strengthen legal obligations and decrease ambiguity for the US Food and Drug Administration…”
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Accelerated Approval — Taking the FDA’s Concerns Seriously by Sachs, Rachel E., Donohue, Julie M., Dusetzina, Stacie B.

“…User-fee reauthorization creates new opportunities for the FDA to address issues with its accelerated-approval program, including the lack of evidence of…”
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Limiting State Flexibility in Drug Pricing by Bagley, Nicholas, Sachs, Rachel E

“…To reduce the burden of high-cost, low-value drugs, Massachusetts has proposed establishing a closed formulary, in which certain drugs can be excluded from…”
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Encouraging New Uses for Old Drugs by Sachs, Rachel E, Ginsburg, Paul B, Goldman, Dana P

“…US Food and Drug Administration approval of a new drug typically coincides with a period of patent protection, during which the manufacturer will often apply…”
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Confronting State Medicaid Drug Spending Pressures by Sachs, Rachel E, Donohue, Julie M, Dusetzina, Stacie B

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An FDA Commissioner for the 21st Century by Chandra, Amitabh, Sachs, Rachel E

“…The FDA faces challenges including a speed-versus-safety trade-off, the need to work well with industry, pressure on drug pricing, and tough policy choices…”
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Commercial Health Plan and Enrollee Out-of-Pocket Spending on Accelerated Approval Products in 2019 by Jazowski, Shelley A, Vaidya, Avi U, Donohue, Julie M, Dusetzina, Stacie B, Sachs, Rachel E

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Time to Confirmatory Study Initiation After Accelerated Approval of Cancer and Noncancer Drugs in the US by Jazowski, Shelley A, Vaidya, Avi U, Donohue, Julie M, Dusetzina, Stacie B, Sachs, Rachel E

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Expansion of the Medicare 340B Payment Program: Hospital Participation, Prescribing Patterns and Reimbursement, and Legal Challenges by Bach, Peter B, Sachs, Rachel E

“…The 340B program began as a means to lower the cost of outpatient medications for a small set of under-resourced health care facilities that served primarily…”
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Addressing Pharmaceutical Price Spikes Through Generic Preclearance by Sachs, Rachel E.

“…Policymakers have been searching for a way to address the problem of prescription drug list price spikes, but they have not yet settled on a way to do so…”
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Innovation-Innovation Tradeoffs in Drug Pricing by Sachs, Rachel E, Frakt, Austin B

“…The uproar about the price of the EpiPen is the latest episode in the controversy over drug pricing that extends back decades. However, the more recent,…”
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