• District of Columbia: The U.S. Supreme Court appears to be divided over a ruling that requires the federal government to cover more healthcare costs for Native American tribes. HHS has asked the Supreme Court to reverse two lower court decisions, which  ruled that tribes were entitled to funds to cover the costs of implementing their healthcare programs. According to HHS, Congress did not intend for tribes to receive additional funds for healthcare costs. However, some justices expressed concern that the government could be depriving the tribes of money that was desperately needed. "It's not as if all of this money is bringing us to a luxury health care spa," said Justice Sonia Sotomayor. "It's actually bringing us to a fairly minimal level of health care for tribal members." Other justices said that ruling in the tribes' favor could leave the government with significant financial costs. According to Justice Samuel Alito, the government estimated that repaying the tribes could cost $12 billion — although the tribes have pushed back against this figure. A ruling on this case is expected by the end of June. (Reichmann, Courthouse News Service, 3/25)
• Maryland: FDA has proposed a ban on electrical stimulation devices used to reduce or stop harmful behavior. According to the agency, the devices "present an unreasonable and substantial risk of illness or injury." Currently, the Judge Rotenberg Education Center is the only facility in the U.S. that uses the devices as a potential part of treatment plans for around 50 people. This is the second time FDA has proposed banning these devices. In 2020, FDA issued a final rule banning the devices from the marketplace, but it was annulled following a federal appeals court ruling that FDA did not have the authority to ban the devices. Since then, FDA has said that changes to the Federal Food, Drug, and Cosmetic Act make it clear that the agency has the authority to issue a ban. The new proposal is open for comment until May 28. After that, FDA will review and consider any comments before deciding whether to issue a final rule. "Those exposed to these devices may need time to gradually transition away from this device and adjust treatment plans," the agency said. "The FDA intends to consider the needs of these patients should we finalize the proposed ban." (Cheng, CNN, 3/25)
• New Jersey: Novo Nordisk on Monday announced plans to acquire Cardior Pharmaceuticals in a deal worth up to $1.1 billion. The Cardior acquisition would allow Novo to add new drugs to its lineup of cardiometabolic medications. Cardior develops medicines that target RNA to address the root causes of heart disease. Its lead candidate, called CDR132L, is currently in Phase 2 development to treat heart failure. The companies did not disclose how much the deal is worth, but it is expected to close in the second quarter of the year. "By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development," said Novo's EVP for development, Martin Holst Lange. (Joseph, STAT+ [subscription required], 3/25)

The pharmaceutical market is experiencing significant shifts, and you need to be prepared. Explore the major trends shaping the industry, including the rise of high-cost drugs and the impact of changing policies, and find out what they mean for your organization.