onthedocket Supreme Court considers cases related to pharmacy June 23, 2011, the Supreme Court of the United States issued two longawaited legal opinions that have implications for pharmacy. Both opinions focus on interpretations of legal precedents, largely ignoring the broader policy context of the responsibilities reviewed within each case. The case of Pliva Mensing1 considers the legal responsibilities of generic manufacturers to update product labeling. The case of Sorrell IMS Health, Inc.2 reviews the extent to which state governments may restrict the sale by pharmacies of data for marketing purposes. Pliva Mensing Patients who developed tardive dyskinesia after use of metoclopramide sued the manufacturers of the generic metoclopramide products they had been dispensed by their pharmacists. In their product liability lawsuits, the patients contended that state laws had been violated because the generic manufacturers provided inadequate warnings in their labeling. The defendants argued that, under federal law, their products approved pursuant to an Abbreviated New Drug Application must use the same labeling as is used by the brand-name product approved through a New Drug Application. They argued that it would be impossible to simultaneously comply with federal law requiring the standard labeling and with state law requiring different labeling with stronger warnings. The Supreme Court agreed that federal law requires generic manufacturers to use the same labeling as the tradename manufacturer. To hold a generic manufacturer liable for failing to modify its labeling would impose liability for failing to do the impossible. While acknowledging that the right of a patient harmed by inadequate warnings depends entirely on whether the pharmacist dispensed a brand-name or generic product, the court held that federal law preempts the claim brought by the patients in this case. The court said, is not this task to decide whether the statutory scheme established by Congress is unusual or even bizarre. As always, Congress and the FDA retain the authority to change the law and regulations if they so Sorrell IMS Health, Inc. Aggregators of pharmacy data sued the State of Vermont after that state passed a law (Act 80) forbidding pharmacies and other businesses to sell data to be used for marketing purposes. The plaintiffs claimed that this law violated their First Amendment right to freedom of expression. Vermont offered several for restricting speech under Act 80. In reviewing these the court noted that the First Amendment requires very careful judicial scrutiny whenever the government restricts speech simply because the government disagrees with the message the speech conveys. Vermont contended that Act 80 protects prescribers from sales by pharmaceutical sales representatives who know from the data how prescribers are prescribing. The court disagreed, noting, can, and often do, simply decline to meet with detailers, including detailers who use prescriber-identifying Referring to a prior case involving doorto-door religious solicitation, the court said, privacy even in own home receives ample protection from the unquestioned right to refuse to engage in conversation with unwelcome Vermont argued that Act 80 prevents the relationship from being undermined by when prescribers learn their prescription decisions are being monitored by The court disagreed, noting, pharmaceutical marketing affects treatment decisions, it does so because doctors it The court also rejected the argument that Act 80 lowers health care costs by reducing effectiveness of marketing brand-name drugs. The court stated, fear that people would make bad decisions if given truthful information cannot justify content-based burdens on The court concluded, capacity to and publish personal information, including records required by the government, presents serious and unresolved issues with respect to personal privacy and the dignity it seeks to secure. In considering how to protect those interests, however, the State cannot engage in content-based discrimination to advance its own side of a The court ruled that Act 80 violated the First Amendment. Conclusion In these two cases, the Supreme Court interpreted the law without involving itself in public policy making. The Supreme Court can public policy by interpreting the law, but the court cannot change the law. Those who wish to public policy through changes in the law should address their concerns to Congress. B. Brushwood, BSPharm, JD Contributing writer References 1. 2011 U.S.LEXIS 4793 (June 23, 2011). 2. 2011 U.S.LEXIS 4794 (June 23, 2011). ABOUT THE AUTHOR David B. Brushwood, BSPharm, JD, is Professor of Pharmacy Health Care Administration at the University of Florida College of Pharmacy in Gainesville. 24 PHARMACY TODAY AUGUST 2011 www.pharmacytoday.org