For The Defense, November 2012 - DRI Today

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Drug and Medical Device receive the most innovative treatments available for their medical conditions. In addition to having a chilling effect, if adopted as it stands the FDA guidance also may unduly burden permissible exchanges of medical information. For example, irrespective of the forum, a firm can only respond to a question about off- label information directly “to the individual making Unless the FDAmakes major modifications before finalization, the guidance as it stands will potentially increase uncertainty for drug manufacturers. the request… as a private, one-on-one communication.” U.S. Food and Drug Admin., Unsolicited Requests, supra, at 7. This example in the draft guidance illustrates the misguided nature of the policy regarding public requests for information: the FDA will classify a request as a public request when someone asks a manufacturer’s representative a question about an off- label use during a live presentation to multiple people. According to the draft guidance, any response must be “limited to providing the firm’s contact information and should not include any off- label information.” Id. at 11 (emphasis in original). Notably, this same scenario applies to most requests submitted through social media. If an individual posts a question about an off- label use in a public Internet forum, a response can only consist of the firm’s contact information. This policy is counterproductive. By not responding to a direct question with a direct answer it appears that a firm has something to hide, and the inquiring health care professional cannot receive a prompt answer to a legitimate medical question. 26 ■ For The Defense ■ November 2012 Off-Label Marketing and the First Amendment Clearly some of the policies proposed by the FDA in the draft guidance regarding unsolicited requests for off- label use information do not advance public health, but the general FDA policy on off- label marketing also may violate the First Amendment. Historically, commercial speech was not considered protected speech, but over the past 40 years commercial speech increasingly has garnered First Amendment protection. This trend began in 1976 with the Supreme Court decision that a Virginia law prohibiting advertising prescription drug prices violated the First Amendment. Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748 (1976). Four years later, in Central Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n, the Court established a four-prong test for determining whether particular commercial speech deserves First Amendment protection from government regulation. 447 U.S. 557 (1980). The test espoused in Central Hudson— still the controlling standard—first evaluates whether the speech promotes illegal activity or misleads. If so, the speech would not warrant protection. If the speech promotes legal activity and is truthful, then the second question a court asks is whether the restriction advances a substantial government interest. If a court determines that the restriction advances a substantial government interest, then a court would next ask whether “the regulation directly advances the government interest asserted.” Finally, the last prong asks “whether [the regulation] is not more extensive than is necessary to serve that interest.” Id. at 566. The government bears the burden of persuasion for the final three prongs, and if the government does not meet the burden for all three, a court generally will find the regulation unconstitutional. Coleen Klasmeir & Martin H. Redish, Off- Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection, 37 Am. J. L. and Med. 315, 338 (2011). Under the Central Hudson framework, commercial speech has received expanding First Amendment protection. See, e.g., Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011); Thompson v. W. States Med. Ctr., 535 U.S. 357 (2002); Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001). The case law under the Central Hudson framework may support the proposition that the federal ban on off- label drug-use marketing may be unconstitutional. Under the first prong of the Central Hudson test, the commercial speech must promote lawful activity and be truthful to warrant First Amendment protection. Courts have held that off- label marketing satisfies this prong as long as the information disseminated is not inherently misleading because the underlying activity being promoted—off- label use of an FDAapproved drug—is lawful. United States v. Caronia, 576 F. Supp. 2d 385, 397 (E.D.N.Y. 2008) (citing Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 66–67 (D.D.C. 1998) (defining inherently misleading as “more likely to deceive the public than inform it”); United States v. Caputo, 288 F. Supp. 2d 912, 920–21 (N.D. Ill. 2003). Advertising is not inherently misleading because it promotes a particular point of view. The Supreme Court has stated that it is unlawful to ban truthful advertising that does not mislead simply because it has an effective sales pitch. See Sorrell, 131 S. Ct. at 2671; Liquormart, Inc., 517 U.S. at 503 (“Bans on truthful, nonmisleading commercial speech… usually rest on the offensive assumption that the public will respond irrationally to the truth”). See also U.S. Food and Drug Admin., Unsolicited Requests, supra, at 10 (acknowledging that manufacturers are capable of responding to requests for off- label information in a “truthful, nonmisleading, and accurate manner”). Once a manufacturer demonstrates that the disseminated information is truthful, as mentioned the burden shifts to the government to justify the commercial speech regulation. The first part of this burden, the second prong discussed in Central Hudson, requires the government to show that the regulation restricting commercial speech advances a substantial government interest. This is a relatively easy burden for the agency to satisfy, and courts have held that the FDA position that the ban encourages manufacturers to participate fully in the FDA regulatory process is sufficient. Thompson, 535 U.S. at 369–70 (holding that the government has a substantial government interest preserving the FDA new drug approval process). But cf. Friedman, 13 F. Supp. 2d at 69–71 (ensuring that physicians receive accurate and unbiased information does not qualify as a substantial gov-
ernment interest); Klasmeir, supra, at 346. Consequently, a successful First Amendment challenge to the FDA ban on off- label drug-use marketing will likely have to demonstrate that the FDA has failed to satisfy the third or fourth prongs of the Central Hudson test or both prongs. The third prong requires the FDA to show that the ban on off- label marketing directly advances the government interest asserted. Whether the FDA can satisfy this burden regarding off- label drug-use marketing is questionable even though current case law holds that an off- label marketing ban does directly advance a substantial government interest in preserving the integrity of the FDA approval process. See Thompson, 535 U.S. at 371(finding that prohibiting advertising for products that have not undergone FDA screening may encourage manufacturers to submit their products to the testing process); Friedman, 13 F. Supp. 2d at 72 (determining that “one of the few mechanisms available to the FDA to compel manufacturers behavior is to constrain their marketing options; i.e., control the labeling, advertising and marketing”). Accord Caronia, 576 F. Supp. 2d at 401. However, as the third prong analyzes the asserted government interest, if the asserted interest encompasses the stated interest of protecting the public health, then the current FDA policy does not directly advance that interest. See U.S. Food and Drug Admin., Unsolicited Requests, supra, at 3. The FDA draft guidance acknowledges that “off- label uses or treatment regimens may be important therapeutic options and may even constitute a medically recognized standard of care” and that manufacturers often have the most complete information about a drug’s off- label use. See id. at 2. Consequently, a persuasive argument exists that current FDA policy has a detrimental effect on the public health because firms cannot inform physicians about therapeutic off- label uses. Due to the FDA policies limiting dissemination of information, patients may not receive the most innovative therapies for their conditions. See Klasmeir, supra, at 346. Accordingly, depending on the level of generality used to characterize its justification, the FDA draft guidance policies arguably does not satisfy the Central Hudson third prong because the policies prevent the dissemination of valuable information, which negatively affects the availability of helpful medical treatments. That the proposed policies articulated in the FDA draft guidance includes forbidding firms from publicly correcting untrue or misleading information about off- label drug uses further undermines that FDA-stated purpose to make helpful medical treatments available. See U.S. Food and Drug Admin., Unsolicited Requests, supra, at 10–12. The government must also satisfy the fourth prong of the Central Hudson test, whether a regulation is more restrictive than necessary to promote a substantial government interest. The government might have problems with this prong because current case law suggests that the prohibition on off- label drug-use marketing may not satisfy that burden. In Wash. Legal Found. v. Friedman, the court held that prohibiting the distribution of independent textbook excerpts and article reprints from medical and scientific journals concerning off- label drug uses was unconstitutional because the regulation was more extensive than was necessary to advance the substantial government interest in encouraging manufacturers to submit all drug uses to the FDA for approval. 13 F. Supp. 2d 51, 54–55 (D.D.C. 1998) vacating as moot, Wash. Legal Found. V. Henney, 202 F.3d 331 (D.C. Cir. 2000) (vacating the district court judgment after the FDA adopted the position that the Food and Drug Administration Modernization Act and the guidance at issue did not confer authority to the FDA to prohibit or to sanction speech). Importantly, the district court held that the FDA had less restrictive means available to achieve the substantial government interest of encouraging manufacturers to submit all drug uses to the FDA for approval that would not burden commercial speech; namely, the “full complete, and unambiguous disclosure by the manufacturer,” including a disclaimer that the FDA had not approved the off- label use. Id. at 72–73. But see United States v. Caronia, 576 F. Supp. 2d 385, 397 (E.D.N.Y. 2008) (holding that the off- label marketing ban was constitutional partly because the court could not “identify non-speech restrictions that would likely constrain in any effective way manufacturers from circumventing the approval process”). Despite the different reasoning articulated by the court in Caronia, 576 F. Supp. 2d at 397, the Friedman court instructively reasoned that full disclosure rather than regulation “comports with the Supreme Court’s preference for combating potentially problematic speech with more speech.” 13 F. Supp. 2d at 73. Subsequently, the Supreme Court has indicated a strong reluctance to condone regulations that burden commercial speech when the government has other means of regulation available. In Thompson v. W. States Med. Ctr., the Supreme Court held that a law that prohibited pharmacies from advertising compounded drugs was unconstitutional. 535 U.S. 357 (2002). The Court determined that the law did not satisfy the forth prong of the Central Hudson test because “the Government… failed to demonstrate that the speech restrictions [were] not more extensive than [was] necessary to serve those interests.” Id. at 371 (internal citations omitted). Specifically, the Court suggested that the government could adopt acceptable alternatives to a commercial speech restriction such as limiting the volume of compounded drugs that a pharmacy could sell or limiting the percentage of total revenue that compounded drug sales could account for. Id. at 372. The FDA potentially could also adopt these measures as less restrictive alternatives to the current FDA ban on off- label drug-use marketing. In Sorrell v. IMS Health, the U.S. Supreme Court determined that the First Amendment is hostile toward any regulation that places restrictions on commercial speech in the name of the public good. Sorrell held that a Vermont law that prevented pharmacies from selling prescription information to pharmaceutical companies for marketing purposes violated the First Amendment because it did not directly advance the state interest in protecting medical privacy and reducing health-care costs. Sorrell, 131 S. Ct. at 2668. The Court declared that “[s]peech in aid of pharmaceutical marketing… is a form of expression protected by the Free Speech Clause of the First Amendment.” Id. at 2659. Specifically the Court wrote that “[t]he 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.” Id. at 2670. (finding fault addi- Off-Label, continued on page 81 For The Defense ■ November 2012 ■ 27
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