Sorrell v. IMS Health Inc. — Supreme Court Strikes Down Law Restricting Pharmaceutical Manufacturers’ Speech

by Ropes & Gray LLP
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On Thursday, the Supreme Court issued its decision in Sorrell v. IMS Health Inc., a case testing the constitutional limits of governmental restrictions on the speech of pharmaceutical manufacturers. By a vote of 6-3, the Court held that the law at issue — a Vermont statute that prohibits pharmaceutical manufacturers from obtaining or using “prescriber-identifiable information” collected from pharmacists for the purposes of “marketing or promoting a prescription drug” — is a “speaker- and content-based burden on protected expression” that cannot survive “heightened judicial scrutiny.” In stressing that “[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment,” Sorrell may set the stage for a constitutional challenge to what is arguably the most draconian governmental restriction on healthcare related speech: the Food and Drug Administration’s web of regulations that make it a federal crime for a pharmaceutical manufacturer to engage in truthful, non-misleading speech about off-label uses of its FDA-approved products.

In 2007, Vermont enacted the Prescription Confidentiality Law, commonly referred to as “Act 80,” in response to the concern that pharmaceutical manufacturers were having too much success in persuading doctors to prescribe brand-name drugs rather than cheaper drugs promoted by generic manufacturers as alternatives. The Vermont legislature had concluded that manufacturers’ successes in marketing brand-name drugs were largely the result of their ready access to so-called “prescriber-identifiable information,” publicly available information from which individual doctors’ prescribing practices could be discerned. According to the Vermont legislature, manufacturers had been using prescriber-identifiable information to help their sales representatives “shape their messages [to doctors] by ‘tailoring’ their ‘presentations to individual prescriber styles, preferences, and attitudes.’” As its chosen solution to this problem, the Vermont legislature included in Act 80 the following provision: “Pharmaceutical manufacturers and pharmaceutical marketers shall not use prescriber-identifiable information for marketing or promoting a prescription drug unless the prescriber consents . . . .” The Vermont legislature intended the provision to make it more difficult for manufacturers to steer doctors toward brand-name drugs and, thereby, to help reduce the overall cost of health care in the state.

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