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?
On this episode, Epstein Becker Green attorneys Jack Wenik, Teddy McCormick, Zach Taylor, and Tracey Gonzalez discuss recent updates to the FDA and FTC guidelines as they apply to ...
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.
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Recent Updates
- Colorado SB 24-205: Addressing AI Risk with Sweeping Consumer Protection Law
- Podcast: Unveiling Gender-Affirming Care: Why It Matters and What’s at Stake – Diagnosing Health Care
- Importance of Negotiating Maintenance, Repair and Replacement Obligations in Health Care Leases
- Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program
- Federal Update on Cannabis Scheduling: Are State Legalized Cannabis Dispensaries to Become Pharmacies?