In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same.
In light of these recent actions, what challenges are dietary supplement manufacturers now facing?
It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.
- Podcast: Telehealth Post-Public Health Emergency – What to Expect in 2024 – Diagnosing Health Care
- Unpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic
- Warning - Transaction Delays Expected. State Notice Requirements Ahead for Health Care M&A!
- New York Aims to Bolster Hospital Cybersecurity with Imminent Release of Proposed Regulations
- Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance