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Health Law Highlights

Wade’s Health Law Highlights for October 29, 2024

Eli Lilly Targets Compounding Kits

Eli Lilly has filed a lawsuit against Pivotal Peptides, a drug vendor in Washington state, accusing them of selling do-it-yourself kits for making knockoff versions of their weight-loss and diabetes drugs, Zepbound and Mounjaro.

Pivotal Peptides allegedly sold these kits without requiring a prescription or medical consultation, labeling the ingredients as “research chemicals” not intended for human use. The company ignored a cease-and-desist letter from Lilly and continued operations under a guise, using coded language to sell their products.

The lawsuit alleges serious safety issues, as these untested and non-pharmaceutical-grade drugs could be ordered by anyone.

Lilly’s legal actions are part of a broader effort to address the sale of illicit tirzepatide versions amid ongoing legal debates over compounded drug formulations.

The FDA had previously declared a shortage of tirzepatide, allowing licensed pharmacies to legally compound the drug, but is now reconsidering this decision following lawsuits from compounding pharmacies. Eli Lilly emphasizes the significant risks posed to patient safety by the sale of these unapproved and potentially harmful drugs.

Anti-Discrimination

  • The Department of Health and Human Services’ final rule implementing Section 1557 of the Affordable Care Act prohibits discrimination in healthcare and requires covered entities to appoint coordinators, post nondiscrimination notices, and implement policies and procedures by specific deadlines. Covered entities must also ensure patient care decision support tools are used non-discriminatorily and provide language assistance and auxiliary aids by May 1, 2025.

Blockchain

  • The global “Blockchain Technology in Healthcare” market is projected to grow significantly, driven by its potential to enhance security, efficiency, and transparency in healthcare services. Blockchain technology offers secure storage of electronic health records, streamlines data management, and improves drug traceability. Recent developments highlight the ongoing integration of blockchain in healthcare, with companies like IBM and Patientory Inc. making strides in the field.

Data Breaches

Health Data

HIPAA

Reproductive Health

Weight Loss