Key Takeaways
- Novo Nordisk (NVO) has significantly expanded its legal actions, filing 14 new lawsuits to combat the sale of unsafe, non-FDA-approved compounded "semaglutide," bringing its total to over 130 lawsuits across 40 states.
- The U.S. Food and Drug Administration (FDA) has ended its grace period for mass compounding of "semaglutide" as the shortage of approved Wegovy and Ozempic is resolved, making such compounding illegal with rare exceptions.
- The Federal Reserve Board and the Federal Deposit Insurance Corporation (FDIC) have released the public sections of resolution plans, often called "living wills," for several large banking organizations, fostering transparency in the financial sector.
Novo Nordisk (NVO) is intensifying its efforts to protect U.S. patients from unapproved and potentially unsafe compounded versions of "semaglutide," the active ingredient in its blockbuster drugs Ozempic and Wegovy. The pharmaceutical giant announced the filing of 14 new lawsuits, contributing to a total of over 130 legal actions across 40 states. These lawsuits have already resulted in 44 permanent injunctions against entities illegally marketing and selling knockoff versions of its GLP-1 medicines.
The company alleges that some telehealth providers are violating state corporate practice of medicine laws by improperly influencing doctors' decisions and steering patients towards these unapproved compounded products. Many of these knockoff drugs are reportedly made with illicit foreign active pharmaceutical ingredients (API) that lack proper oversight and safety standards. This aggressive legal stance follows recent warnings from the FDA regarding the serious dangers associated with compounded GLP-1 drugs.
The expanded legal action coincides with the expiration of the FDA's grace period for mass compounding of "semaglutide." With the FDA declaring the shortage of Wegovy and Ozempic resolved and both fully available nationwide, it is now illegal under U.S. compounding laws to make or sell knockoff "semaglutide" drugs, with rare exceptions. Novo Nordisk is also launching new initiatives to support patient access to authentic, FDA-approved Wegovy, including a limited-time offer providing the first month of medicine for $199 for eligible self-paying patients, and subsequent months for $499. Additionally, the company is rolling out "Choose the Real Thing" and "Check Before You Inject" campaigns to educate patients on the risks of counterfeit products.
In other financial news, the Federal Reserve Board and the Federal Deposit Insurance Corporation (FDIC) have released the public sections of resolution plans for several large banking organizations. These plans, commonly known as "living wills," outline a firm's strategy for a rapid and orderly resolution under bankruptcy in the event of material financial distress or failure.
Required by the Dodd-Frank Act, these resolution plans aim to enhance financial stability by ensuring that large banks can be wound down without causing systemic disruption. The public sections summarize key elements of these plans, promoting transparency in the banking sector. This release provides insights into how major financial institutions, including those that submitted plans by December 1, 2023, are prepared to manage potential crises.
Ed Liston is a senior contributing editor at TheStockMarketWatch.com. An active market watcher and investor, Ed guides an independent team of experienced analysts and writes for multiple stock trader publications.