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
- Data breaches are costly, with healthcare and finance industries facing the highest penalties due to stringent regulations. Data masking is a solution that allows businesses to comply with regulations while maintaining data usability. Organizations must implement data masking alongside encryption and PAM to protect sensitive data and avoid regulatory penalties.
- Over 940,000 Medicare beneficiaries’ protected health information was exposed due to a vulnerability in MOVEit software used by WPS. CMS and WPS are investigating the breach, offering credit monitoring and new Medicare cards to affected individuals. Healthcare organizations should review vendor contracts, conduct regular cybersecurity audits, and enhance incident response plans to safeguard against similar incidents.
Health Data
- Health and fitness apps and digital health platforms collect personal health data, but HIPAA does not apply to most of them. State-specific data privacy laws, such as California’s CMIA and Washington’s MHMDA, regulate the collection and use of consumer health data, including the right to consent, delete, and know how data is shared. Businesses must comply with these laws by requiring consent, implementing privacy policies, and ensuring data security.
HIPAA
- HHS is working on updating the HIPAA Security Rule to address the increasing cyber threats in the healthcare sector, including ransomware attacks and data breaches. The proposed modifications may include a thorough enterprise-wide HIPAA security risk analysis. The outcome of the upcoming presidential election could impact the implementation of these regulations, with a potential shift in priorities and enforcement approaches.
- The Office of Civil Rights (OCR) has resumed HIPAA audits after a seven-year hiatus due to a surge in data breaches and cyberattacks. Entities must strengthen their compliance programs, including conducting risk assessments, implementing safeguards, and providing detailed documentation of compliance. Non-compliance can result in financial penalties and corrective actions.
- Texas is challenging to the Biden administration’s new rule strengthening the Health Insurance Portability Act (HIPAA). The rule prohibits healthcare providers, insurers, and states from giving reproductive care information to criminal or civil investigations. Texas is fighting to access out-of-state abortion medical records, which could lead to the criminalization of abortion-seeking residents.
- BAAs are often treated as boilerplate documents, but they require careful review and negotiation to ensure compliance with HIPAA regulations. It is important to update the agreements regularly to reflect current laws. In terms of substance, counsel should ensureg clear reporting obligations, and avoid overly restrictive terms that could hinder a business associate’s operations. Failing to properly execute or update a BAA can result in severe penalties. BAAs are not “one-size-fits-all” and should be tailored to support a robust privacy compliance program.
Reproductive Health
- A Texas doctor is suing the HHS to prevent enforcement of a new HIPAA rule that strengthens reproductive health care privacy. The rule prevents HIPAA-regulated entities from disclosing reproductive health care information to law enforcement, but the doctor argues it restricts her ability to report suspected abuse. The lawsuit follows a similar suit filed by the Texas Attorney General.
- A Texas doctor sued the Biden administration over a new rule strengthening privacy protections for abortion and gender transition treatments. The doctor argues the rule prevents reporting possible abuse and violates state law. The lawsuit was filed in Amarillo, ensuring it will be heard by a conservative judge who previously suspended the approval of the abortion pill mifepristone.
- A Texas doctor is suing the Biden-Harris administration over recent changes to federal health privacy laws that restrict doctors’ ability to report suspected abuse and protect patients from the harms of abortion and gender transition. The new rule redefines “person” and “public health” to exclude unborn children and limits how doctors and law enforcement can protect patients from abuse. Alliance Defending Freedom attorneys argue that the rule exceeds government authority and undermines state laws that protect mothers and children from the harms of abortion and gender transition.
Weight Loss
- Novo Nordisk has requested the FDA to prohibit compounding pharmacies from producing unapproved versions of Ozempic and Wegovy, citing safety concerns. The FDA is reviewing the petition and will respond directly to Novo Nordisk.
- Diabetes patients face insulin shortages due to increased demand for weight loss drugs like Ozempic. The three major insulin manufacturers, Novo Nordisk, Eli Lilly, and Sanofi, are under pressure to prioritize insulin production amidst supply chain disruptions and the lucrative market for weight loss drugs. Despite price cuts, diabetes patients worry about the reliability of insulin supply, which is essential for their survival.