News & Analysis as of

Chevron Deference Prescription Drugs

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

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Please see full Newsletter below for more information....more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Epstein Becker & Green

Recent Supreme Court Decisions and the DSCSA

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The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more

McDermott Will & Emery

Loper Bright and the 340B Statute

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In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more

Venable LLP

Implications of Loper Bright for FDA-Regulated Products

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Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Axinn, Veltrop & Harkrider LLP

FDA After Chevron

Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council,...more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

ArentFox Schiff on

The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

Holland & Knight LLP

Holland & Knight Health Dose: January 24, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Holland & Knight LLP

Supreme Court Rejects Adjustments to Certain Prescription Reimbursements

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The U.S. Supreme Court sided with medical providers on June 15, 2022, after the U.S. Department of Health and Human Services (HHS) cut Medicare Part B reimbursements to healthcare providers serving disadvantaged communities....more

Goldberg Segalla

Chevron Deference on Life Support?

Goldberg Segalla on

The U.S. Supreme Court on June 15 issued a unanimous reversal of a lower appellate court, and in which, ruling against the federal government, struck down a Department of Health and Human Services rule significantly reducing...more

Foley Hoag LLP - Medicaid and the Law

Supreme Court Hears Arguments on 340B Outpatient Payment Cuts—and Discusses ‘Chevron Deference’

Over the summer, my colleague Tom Barker discussed how the Supreme Court was planning to hear several health care cases during the October 2021 term. Last week, the Court heard oral arguments for two noted cases: during...more

Bricker Graydon LLP

Supreme Court makes certiorari determinations on two Medicare-related cases

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A number of health care related cases have come before the United States Supreme Court this session, including two cases on topics we have previously reported on: Medicare’s site-neutral payment policy for off-campus...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2021

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Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more

Dorsey & Whitney LLP

The Supreme Court - July 2, 2021

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Hughes v. Northwestern University, No. 19-1401: Whether allegations that a defined-contribution retirement plan paid or charged its participants fees that substantially exceeded fees for alternative available investment...more

Troutman Pepper

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

K&L Gates LLP on

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

Robins Kaplan LLP

Amarin Pharms. Ireland Ltd v. FDA

Robins Kaplan LLP on

Case Name: Amarin Pharms. Ireland Ltd v. FDA, Case No. 14-cv-00324 (RDM), 2015 U.S. Dist. LEXIS 68723 (D.D.C. May 28, 2015) (Moss, J.) - Drug Product and Patent(s)-in-Suit: Vascepa® Capsules (icosapent ethyl); N/A...more

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