On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more
On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s free product offering to...more
On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more
On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more
8/1/2024
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Fertility Treatments ,
Financial Aid ,
Life Sciences ,
Manufacturers ,
OIG ,
Patient Assistance Programs ,
Patients ,
Pharmaceutical Industry ,
Travel Expenses
On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more
7/11/2024
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Life Sciences ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Refunds ,
Risk Mitigation
On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...more
On September 25, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued an unfavorable Advisory Opinion No. 23-06 related to a proposed arrangement involving purchasing the technical...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
8/18/2023
/ Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
NAD ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Warning Letters
On February 28, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 23-02 (“Opinion”), which favorably addresses a pharmaceutical manufacturer’s proposal to offer a free limited supply of medication for...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
The Department of Health and Human Services, Office of Inspector General (OIG) recently issued an Advisory Opinion analyzing an arrangement where a drug manufacturer (the “Requestor”) provides financial assistance to cover...more