| | | Litigation Report | The Association for Accessible Medicines, an industry group representing generic and biosimilar medications, has asked a federal judge in Connecticut to pause enforcement of a law in the state that would put a cap on generic drug prices. The group argues that the law, which took effect July 1 and begins regulating prices in January 2026, violates the U.S. Constitution’s commerce clause by trying to control transactions that happen outside the state. Drugmakers sell products to wholesalers and distributors, which then make their way to pharmacies and providers. “The fundamental question in this case is whether Connecticut may directly regulate the price of goods sold in other states. The answer is no,” AAM writes in the filing. “The Constitution reserves such power to regulate interstate commerce to the national government.” The law “does not regulate the price at which drugs are sold to patients at a pharmacy in Connecticut. Rather, starting Jan. 1, it caps the price at which manufacturers and wholesale distributors may sell generic and biosimilar products — leaving retailers and other resellers in Connecticut free to impose price increases,” AAM writes in the filing. AAM goes on to say that halting enforcement would ultimately raise costs by discouraging generic competition — therefore making it in the public interest to do so. Why it matters: The case could shape how far states can go in trying to rein in prescription drug costs, especially as more legislatures test the limits of state-level price regulation. But, on an even larger scale, it could set up a Supreme Court challenge to determine the breadth of commerce clause protections. Although AAM scored a legal victory in June when a federal appeals court in the Eighth Circuit blocked a Minnesota price-control law the group said was nearly identical, an Illinois federal court more recently denied AAM’s challenge to the state’s drug pricing law that also invoked the commerce clause. “The doctrine is not clear, and we are currently seeing splits in the courts’ approach,” said Andrew Twinamatsiko, a director of the Center for Health Policy and the Law at the O'Neill Institute, tells me. “I don't necessarily think that the Eighth Circuit is the gospel truth on this one.” Twinamatsiko mentioned the competing decision in Illinois and some ambiguities left by a recent Supreme Court decision on the issue — in which the high court ruled that a California law mandating that pork sold in the state be raised under humane conditions did not violate the constitutional rights of out-of-state pork producers — means that this case isn’t a slam dunk. “The dormant Commerce Clause’s existence is uncontroversial; its boundaries are not,” wrote Chief Judge Virginia Kendall of the U.S. District Court for the Northern District of Illinois in the decision denying AAM’s challenge to the Illinois drug pricing law, ultimately deciding that the group had a “low likelihood of success on the merits.” The judge contended the Eighth Circuit’s decision is a “misreading” of legal precedent. If an appeals court upholds the decision, it would create a circuit split that could eventually send the case to the Supreme Court. |