Health Law Policy
The Ongoing Step Therapy Debate
Senator Lisa Murkowski’s reintroduction of the Safe Step Act has revived the debate over the prudence of step therapy protocols.
The Ongoing Step Therapy Debate
Author
Laura Karas
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Antitrust
Is It Time to Reverse Health System Consolidation?
Concentrated corporate power currently impedes affordable provision of health care across the state of Massachusetts.
Is It Time to Reverse Health System Consolidation?
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Health Law Policy
Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported?
Are manufacturing method patents warranted intellectual property protections, or groundless obstacles to competition?
Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported?
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Antitrust
When “Pay-for-Delay” Becomes “Delay-Without-Pay”: Humira Antitrust Claims
In this post, I explore several problematic aspects of the court’s reasoning for rejecting the claims of pay-for-delay and market allocation.
When “Pay-for-Delay” Becomes “Delay-Without-Pay”: Humira Antitrust Claims
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FDA
Year in Review: Biosimilars
In November 2020, the FDA released its most recent draft guidance for industry on biosimilarity and interchangeability
Year in Review: Biosimilars
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FDA
Graphic Warnings on Cigarettes: Public Health vs. Corporate Speech
Color graphic warnings are set to appear on cigarette packages in June 2021 as FDA’s latest effort to make a dent in the intractable tobacco problem.
Graphic Warnings on Cigarettes: Public Health vs. Corporate Speech
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FDA
Fortifying the US Pharmaceutical Supply Chain
Reducing dependency on any single nation must be a federal priority, but it can be accomplished only with industry stakeholder buy-in.
Fortifying the US Pharmaceutical Supply Chain
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Behavioral Health
During the COVID-19 Pandemic, the Opioid Epidemic Continues
Between the opioid crisis and the COVID-19 pandemic, America now suffers from a surplus of needless, untimely deaths.
During the COVID-19 Pandemic, the Opioid Epidemic Continues
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Health Law Policy
The Opioid Multidistrict Litigation, Federal Rule 23, and the Negotiation Class
A recent Sixth Circuit decision dashed hopes of a faster resolution to the federal opioid multidistrict litigation (MDL).
The Opioid Multidistrict Litigation, Federal Rule 23, and the Negotiation Class
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Health Law Policy
Following the Yellow Brick Road Toward Hospital Price Transparency
The CMS final rule requiring price transparency for hospital items and services will begin to remedy the information asymmetry patients face.
Following the Yellow Brick Road Toward Hospital Price Transparency
