2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
Consumer Finance Monitor Podcast Episode: The Impact of the Election on the CFPB: What to Expect on Key Regulatory Issues During Trump 2.0
Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies
False Claims Act Insights - How a Marine Fisheries Dispute Opened an FCA Can of Worms
The Loper Bright Decision - What Really Happened to Chevron and What's Next
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 210: Impacts of the Chevron Doctrine Ruling with Mark Moore and Michael Parente of Maynard Nexsen
Podcast - Legislative Implications of Loper Bright and Corner Post Decisions
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Consumer Finance Monitor Podcast Episode: The Demise of the Chevron Doctrine – Part II
Consumer Finance Monitor Podcast Episode: The Demise of the Chevron Doctrine – Part I
In That Case: Loper Bright Enterprises v. Raimondo
Regulatory Uncertainty: Benefits-Related Legal Challenges in a Post-Chevron World — Troutman Pepper Podcast
The End of Chevron Deference: Implications of the Supreme Court's Loper Bright Decision — The Consumer Finance Podcast
#WorkforceWednesday: Can FTC’s Non-Compete Ban Survive Without Chevron Deference? - Spilling Secrets Podcast
The Justice Insiders Podcast: Jarkesy’s Implications for the Administrative State
Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care
#WorkforceWednesday® - Chevron Deference Overturned - Employment Law This Week®
DE Under 3: Retirement of “Chevron Doctrine” Exposed Vulnerability of OFCCP’s Overreaching Interpretations of Some of its Rules
AGG Talks: Healthcare Insights Podcast - Episode 5: What the End of Agency Deference Means for the Healthcare Industry
#WorkforceWednesday® - Key SCOTUS Decisions This Term for Employers - Employment Law This Week®
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more
Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies...more
The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...more
Welcome to Venable’s BiologicsHQ Monthly Injection – August 2024...more
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
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
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
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
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
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
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
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
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