On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
10/10/2024
/ Drug Compounding ,
Food and Drug Administration (FDA) ,
Goods or Services ,
Healthcare ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Supply Shortages
At the end of the 2024 term, the executive branch struck out when the US Supreme Court issued three separate decisions along ideological lines that have the potential to materially weaken the enforcement authority of federal...more
The US Supreme Court has overruled the longstanding Chevron doctrine, an administrative law doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Loper Bright Enterprises v....more
7/5/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
In Loper Bright Enterprises v. Raimondo, the US Supreme Court expressly overruled the doctrine of deferring to an agency’s interpretation of allegedly ambiguous statutory language initially articulated in Chevron U.S.A. Inc....more
Step into the mind of a trial lawyer with On the Stand, a Q&A series. McDermott’s cross-practice trial and appellate lawyers reveal what drives their passion for the courtroom, preparation techniques, advice for junior...more
On October 26, 2023, the Health Resources and Services Administration (HRSA) issued a Notice to “inform and remind” 340B Program covered entities that to be considered eligible for the 340B program, an off-site outpatient...more
McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most.
Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more
10/10/2023
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Antitrust Provisions ,
Attorney-Client Privilege ,
Chief Compliance Officers ,
Compliance ,
Continuing Legal Education ,
Enforcement Actions ,
Events ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Facilities ,
Investigations ,
Life Sciences ,
Physicians ,
Regulatory Requirements ,
Restrictive Covenants
On January 5, 2023, the Federal Trade Commission (FTC) issued a proposed rule that would prohibit employers from using noncompete agreements with their employees or independent contractors. Noncompete agreements are prevalent...more
On January 5, 2023, the Federal Trade Commission (FTC) issued a proposed rule that would prohibit employers from using noncompete agreements with their employees or independent contractors. This proposal arises from a...more
McDermott partners Paul W. Hughes and Michael B. Kimberly, co-chairs of the Firm’s Supreme Court & Appellate Litigation practice, represented James Kisor in the recent Supreme Court case Kisor v. Wilkie, with Paul arguing the...more
7/1/2019
/ Administrative Agencies ,
Ambiguous ,
Appeals ,
Auer Deference ,
Kisor v Wilkie ,
Reasonable Interpretations ,
Remand ,
SCOTUS ,
Stare Decisis ,
Vacated ,
Veterans' Benefits
President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more
6/28/2019
/ Administrative Procedure Act ,
Affordable Care Act ,
American Hospital Association ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Final Rules ,
Healthcare Costs ,
New Legislation ,
Price Transparency ,
Rulemaking Process ,
Secretary of HHS ,
Trump Administration