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Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Law

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65.

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. 18-1156, 2018 U.S. Nagarwala , No.

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Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Court of Appeals (again, see our post ). The pieces of major drug pricing and payment reform are falling together.