For The Defense, December 2011 - DRI Today

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Drug anD MeDical Device “mere beef jerky,” IMS Health Inc. v Ayotte, 550 F.3d 42, 53 (CA1 2008), and the Second Circuit viewed it as speech akin to a “cookbook, laboratory result or train schedule,” the Supreme Court granted certiorari. The Supreme Court analysis began by stating that “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of Sorrell… plainly paves the way for courts to review the First Amendment implications of the patchwork regulatory scheme governing offlabel communications. the First Amendment.” 131 S. Ct. at 2659. The Court found that the law warranted heightened scrutiny because Vermont “designed [the law] to impose a specific, content- based burden on protected expression.” Id. at 2664. The Court wrote that “[t]he First Amendment requires heightened scrutiny whenever the government creates a ‘regulation of speech because of disagreement with the message it conveys.’” Id. Vermont argued, as does the FDA about manufacturer offlabel speech, that heightened scrutiny was not warranted because the law was “a mere commercial regulation.” The Supreme Court disagreed, stating that (1) the “law does not simply have an effect on speech, but is impermissibly directed at certain content and is aimed at particular speakers,” and (2) distinct from previous cases that considered limiting access to using governmental information, the law in Sorrell “implicated” commercially available information and restricted “[a]n individual’s right to speak… when information he or she possesses is subjected to ‘restraint on the way in which the information might be used or disseminated.’” Id. at 2665 (internal citation omitted). In addressing the conflict between the First Circuit and the Second Circuit, the Court stated that “[f]acts, after all, are the begin- 46 ■ For The Defense ■ December 2011 ning point for much of the speech that is most essential to advance human knowledge and to conduct human affairs. There is thus a strong argument that prescriber- identifying information is speech for First Amendment purposes.” Id. at 2667. According to the Supreme Court, Those who seek to censor or burden free expression often assert that disfavored speech has adverse effects. But the “fear that people would make bad decisions if given truthful information cannot justify content- based burdens on speech.” The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. These precepts apply with full force when the audience, in this case prescribing physicians, consists of “sophisticated and experienced consumers.”…That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers. 131 S. Ct. 2670. The Court quoted one Vermont physician: “We have a saying in medicine, information is power. And the more you know, or anyone knows, the better decisions can be made.” Id. at 2671. Sorrell is not an offlabel case, but it plainly paves the way for courts to review the First Amendment implications of the patchwork regulatory scheme governing offlabel communications. Significantly, the Second Circuit will review another First Amendment case, this time squarely addressing the First Amendment in the context of offlabel marketing. U.S. v. Caronia, 576 F. Supp. 2d 385 (E.D.N.Y. 2008) Orphan Medical manufactured and marketed a sleep- inducing depressant, Zyrem. A government informant contacted Mr. Caronia, a sales representative, asking for information on offlabel use and for a presentation by a medical liaison. Mr. Caronia arranged the presentation, and the sting operation resulted in prosecution. Unfortunately for Mr. Caronia, his employer admitted to a conspiracy to misbrand and paid a hefty penalty. In addition, a former manager testified that he had personally instructed the medical liaison to misbrand the product on prior occasions. In denying Mr. Caronia’s motion to dismiss, the trial court presciently stated: Reduced to its essence, Caronia’s argument is that the government cannot restrict truthful, non- misleading promotion by a pharmaceutical manufacturer (or its employees) to a physician of the offlabel uses of an FDA- approved drug… squarely, Caronia’s constitutional attack calls into questions America’s regulatory regime for the approval and marketing of prescription drugs. The court went on to state: “The Constitutional issues raised in Caronia’s motion are very much unsettled, not only in the circuit but nationwide.” The court ruled that “[i]t is clear to the Court that the promotion of offlabel uses of an FDA- approved prescription drug is speech not conduct.” The court found the facts supported three of the four Central Hudson factors and stated: “With that the overture ends and the play begins. Enter on stage the essential question—can government satisfy the fourth prong of Central Hudson?” In answering that question, the Caronia trial court stated that here, the FDA’s maintaining through the FDCA’s misbranding provisions some control over the offlabel promotion of manufacturers does appear essential to maintaining the integrity of the FDA’s new drug approval process…this Court is unable to identify non- speech restrictions that would likely constrain in any effective way manufacturers from circumventing that approval process. The case was tried to a verdict against Mr. Caronia, and the jury convicted him on one count of “conspiracy to introduce or deliver for introduction into interstate commerce a drug, Xyrem, that was misbranded.” The jury imposed a $25 fine and community service as a sentence. With the tide rising on the First Amendment, Mr. Caronia has been joined by amici that have been battling this issue since the days when it was “laughed out of court.” Only now no one is laughing. Caronia is up before the Second Circuit, and supplemental briefing was filed in August 2011, addressing the First Amendment issues raised by the Supreme Court in Sorrell. While it is not clear how the Second Circuit will rule in Caronia, in Sorrell the Second Circuit found that the Vermont statute violated the First Amendment, stat-
ing that “[t]he statute is therefore clearly aimed at influencing the supply of information, a core First Amendment concern…. [T]he First Amendment teaches that courts should assume that truthful commercial information ‘is not in itself harmful.’” 630 F.3d 263, 272 (2d Cir. 2010) (internal citation omitted). The Second Circuit concluded that the state could achieve its goals with less restrictive means: In other words the statute seeks to alter the marketplace of ideas by taking out some truthful information that the state thinks could be used too effectively. The state’s approach to regulating the interaction between detailers and doctors is premised on limiting the information available to physicians as a means of impacting their conduct. This approach is antithetical to a long line of Supreme Court cases stressing that courts must be very skeptical of government efforts to prevent the dissemination of information in order to affect conduct. Id. at 277–78. From “Notable Exception” to Developing Trend? On October 14, 2011, Par Pharmaceuticals filed a declaratory judgment action in the U.S. District Court of the District of Columbia seeking a preliminary injunction preventing the federal government from criminalizing truthful speech that is not misleading to health care providers concerning its FDA- regulated products. At issue in Par is the drug Magace, a drug to treat weight loss or wasting in AIDS patients, which doctors use offlabel more frequently with other populations such as geriatric and cancer patients. Par may pick up where Washington Legal Foundation v. Friedman left off, as a party has again asked that court to issue an injunction barring the FDA from prohibiting truthful speech that doesn’t mislead concerning regulated products. Perhaps this iteration of First Amendment challenges in that court will not “disappear before our eyes” as it did in Washington Legal Foundation v. Friedman. Conclusion The boundary between permissible and impermissible speech regarding offlabel or new uses is vague, and the civil and criminal penalties for a real or imagined misstep are severe. Yet the data show that physicians and the consuming public require more, not less, truthful scientific information regarding the uses to which they put medical products. The current compliance and enforcement regime may not only fail to satisfy the mounting First Amendment challenges, but it may also fail the underlying interest of the improving public health, which it is designed to serve. For The Defense ■ December 2011 ■ 47
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