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Rx Data-Mining Case Reaches Supreme Court

MedpageToday

WASHINGTON -- The Supreme Court will hear arguments Tuesday in a case involving a state law that restricts pharmaceutical companies' use of physician prescribing records.

The case, Sorrell v. IMS Health, Inc., revolves around a 2007 Vermont law that bans the sale and use of prescriber-identifiable information for marketing or promoting a drug -- including drug detailing -- unless a physician specifically gives his or her permission to use the information.

The U.S. Second Circuit Court of Appeals ruled in November that the law is a violation of First Amendment rights because it restricts commercial speech, and that it is a violation of the Commerce Clause of the Constitution because it impinges on interstate commerce, since data-mining companies sell the prescriber information in states other than Vermont.

Similar laws in New Hampshire and Maine have been declared unconstitutional by the First Circuit Court of Appeals. In 2009, the U.S. Supreme Court declined to review the court decision on the New Hampshire law.

When filling prescriptions, Vermont pharmacies collect information including the prescribing physician's name and address; the name, dosage, and quantity of the medication; the date and place where the prescription was filled; and the patient's age and gender.

Pharmacies sell this "prescriber information" to data-mining companies, including the three appellants in the case, IMS Health, Verispan (now SDI), and Source Healthcare Analytics.

Pharmaceutical companies are the primary purchasers of the data, using the information to better target their marketing to individual physicians, and also to direct safety messages to doctors, to track disease progression, to aid law enforcement, to implement risk-mitigation programs, and to do postmarketing surveillance required by the FDA.

When the law was passed, the Vermont legislature said it was intended to protect the public health of the citizens of the state, to protect the privacy of doctors and their prescribing practices, and to keep costs down "through the promotion of less costly drugs," i.e., generics, which aren't marketed and detailed in the same fashion as pricier brand-name drugs.

However, the appeals court agreed with the data-miners that even information on who is prescribing which drugs to whom is speech that is protected by the First Amendment.

Doctors' groups, including the American College of Physicians, have historically opposed the use of physician prescribing data for marketing purposes.

State agencies -- including those in Vermont -- also use prescriber information for law enforcement and other state programs, as do federal agencies such as the FDA, the CDC, and the Drug Enforcement Agency. Researchers, too, use the data to develop new drugs or to identify overuse of a certain drug in a specific population. And insurance companies and pharmacy benefit managers use the data to process claims and manage compliance.