US Supreme Court rejects Vermont's restriction on prescribing data for manufacturers

Pharmaceutical CommercePharmaceutical Commerce - May/June 2011

Decision rides on “free flow of commercial information,” according to the 6-3 vote

Evidence of how important the Supreme Court case of Sorrell vs IMS Health was to IMS can be seen in their near-instantaneous response to the decision, announced June 23. Their statement reads, in part, “Today’s ruling is clear and unmistakable — these types of laws violate the Constitution and do nothing to improve healthcare, reduce costs or protect privacy as proponents had claimed,” said Harvey Ashman, IMS Health senior vice president and general counsel. “Transparency is vitally important to advancing healthcare. The availability of information on the prescribing practices of physicians enables communications about new medicines, best practices and safety updates. This information is essential to improved patient care and safety.”

The closely watched case pitted “data miners” IMS Health along with SDI (now a subsidiary of IMS) and Wolters Kluwer Pharma Solutions, who collectively are the pharma industry’s main source of prescribing data gathered from retail pharmacies and other dispensing locations. The data, de-identified of patient information by various scrubbing mechanisms, can be tied to the prescribing patterns of individual physicians in many cases and this, in turn, enables pharma marketers to track trends in prescribing. One element of the practice is to help inform healthcare professionals of prescribing practices, adverse events and the like; another element is to develop actual sales patterns by which, in some cases, individual pharma reps are incentivized.

The State of Vermont (whose attorney general is William Sorrell), along with Maine and New Hampshire, have written laws to forbid data miners’ access to the data. Yet a crucial weakness of the Vermont law was that the same data could be provided to other parties for “health care research.” Under the evolving legal definition of first-amendment free-speech rights, “commercial speech” like the reporting that data miners would do with access to the prescribing data, can only be restricted when a variety of standards are met, and the Supreme Court ruled that these standards were not met. “Pharmacies may share prescriber-identifying information with anyone for any reason except for marketing,” according to the Vermont law, the majority-opinion writer, Justice Anthony Kennedy, says, “but if pharmaceutical marketing affects treatment decisions, it can do so only because it is persuasive. Fear that speech might persuade provides no lawful basis for quieting it.”

In a dissent, Justice Stephen Breyer argued that the prescriber data do not rise to the level of significance that warrants the “heightened” standard of judicial review of commercial speech, which should generally be reserved for speech that “reflects the constitutional importance of maintaining a free marketplace of ideas, a marketplace that provides access to ‘social, political, esthetic, moral, and other ideas and experiences.’” Justices Ginzburg and Kagan also dissented.

Both in this context as well as others, there has been a belief that physicians’ decisionmaking can not and should not be questioned; the restriction on publishing data on such medical topics as how well individual hospitals are performing has been another touchpoint for industry reviewers. But now, the precedent is in place for more transparency on these data.

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