Drug manufacturer Eli Lilly has filed suit against four companies involved in making, prescribing, and/or selling compounded versions of its weight loss and diabetes drugs ZEPBOUND® and MOUNJARO®....more
4/30/2025
/ Business Litigation ,
California ,
Corporate Practice of Medicine ,
Enforcement Actions ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
State Legislatures ,
Telehealth ,
Unfair Competition
On July 12, 2024, the FDA provided small dispensers—those employing 25 or fewer full-time pharmacists or pharmacy technicians—with an exemption from the Drug Supply Chain Security Act’s (“DSCSA”) enhanced drug distribution...more
On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other...more
8/16/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Price Inflation ,
Rebates ,
Section 340B
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
8/15/2024
/ Chevron Deference ,
Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Loper Bright Enterprises v Raimondo ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
SEC v Jarkesy ,
Supply Chain
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
7/29/2024
/ Drug Distribution ,
DSCSA ,
Exemptions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain ,
Waivers
On February 4, 2022—more than six years after the deadline imposed by statute—the U.S. Food and Drug Administration (“FDA”) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors...more
In the clearest indication yet of the increased enforcement of the Mental Health Parity and Addiction Equity Act (“MHPAEA”) under the Biden-Harris administration, two settlement agreements filed on August 11 provide that...more
On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more
On August 6, 2020, President Donald Trump signed an executive order directing federal agencies to increase domestic procurement and identify supply chain vulnerabilities of certain essential medicine and products. This “Buy...more
Earlier this year, the Environment Protection Agency (“EPA”) adopted a final rule imposing new standards for the management of hazardous waste pharmaceuticals (“HWPs”) that goes into effect on August 21, 2019 (“Final Rule”)....more