Opinion ID: 812956
Heading Depth: 2
Heading Rank: 2

Heading: Applying Central Hudson and Sorrell

Text: Finally, even if using Caronia’s speech as evidence of his intent was not necessarily constitutionally permissible—in other words, even if the protection afforded to commercial speech requires an analysis of this question where the customers of a product like Xyrem may lawfully use it for purposes not addressed in the label, and where the FDA does not purport to regulate the claims made by unrelated third parties about the efficacy of such uses, see George W. Evans & Arnold I. Friede, The Food and Drug Administration’s Regulation of Prescription Drug Manufacturer Speech: A First Amendment Analysis, 58 Food & Drug L.J. 365, 390 (2003)—I believe the correct application of commercial speech principles requires us to uphold Caronia’s conviction. I agree with the majority that our analysis is guided by Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980), and Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011). I conclude, however, that the FDCA’s misbranding provision survives the scrutiny required by those cases because it directly advances a substantial government interest and is narrowly drawn to further that interest. “[O]ne of the [FDCA]’s core objectives is to ensure that any product regulated by the FDA is safe and effective for its intended use.” Brown & 19 Williamson, 529 U.S. at 133 (2000) (internal quotation marks omitted). The FDCA is meant to achieve this objective through a rigorous premarket approval process. See 21 U.S.C. § 355. Under this process, a manufacturer may not sell a drug without first providing proof to the FDA that the drug is “safe for use” and “effective in use.” See id. § 355(b). There must be “substantial evidence,” including evidence from clinical investigations, “that the drug will have the effect it purports or is represented to have.” Id. § 355(d). This process is a central, if not the central, feature of the FDCA. Prior to the passage of the FDCA, the government could combat misleading drug claims only through post-market enforcement actions. The 1938 Act’s “most substantial innovation” was to require approval of a drug’s safety before it could enter the market. Wyeth, 555 U.S. at 566. This innovation became even more important after Congress amended the FDCA in 1962 to also require premarket approval of a drug’s effectiveness for its stated uses. See Drug Amendments of 1962, Pub. L. No. 87-781, § 102, 76 Stat. 780, 781. Behind the 1962 amendments were concerns that doctors could not adequately evaluate frequently misleading claims by drug manufacturers without a body of objective, reliable information. See, e.g., Henry A. Waxman, A History of Adverse Drug Experiences: Congress Had Ample Evidence to Support Restrictions on the Promotion of Prescription Drugs, 58 Food & Drug L.J. 299, 301–08 (2003); Alan H. Kaplan, Fifty Years of 20 Drug Amendments Revisited, 50 Food & Drug L.J. 179, 184–85 (1995). The Supreme Court has accordingly stated that “[p]reserving the effectiveness and integrity of the FDCA’s new drug approval process is clearly an important governmental interest.” Western States, 535 U.S. at 369. Given the benefits of premarket approval, “the Government has every reason to want as many drugs as possible to be subject to that approval process.” Id. The FDCA’s prohibition on off-label marketing directly advances this interest. If drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses. Prohibiting such promotion is thus “one of the few mechanisms available” to encourage participation in the approval process. Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51, 72 (D.D.C. 1998), vacated in part, Washington Legal Foundation v. Henney, 202 F.3d 331 (D.C. Cir. 2000). And premarket approval improves drug safety and effectiveness only to the extent that drugs are not sold without such approval. In concluding that prohibiting off-label promotion does not directly advance the government’s interests, the majority places great weight on the fact that “physicians can prescribe, and patients can use, drugs for off-label purposes.” Maj. Op. at 39. But this is also true for substances that have not been approved by the FDA for any medical use at all. The law generally permits 21 a hardware store to sell turpentine, and though such conduct may not be advisable, the law generally permits a consumer to purchase that turpentine and use it as a pain reliever. Under the majority’s reasoning, then, any substance that may be legally sold for some purpose may be promoted by its manufacturer for any purpose—so long as the manufacturer’s statements are merely unsubstantiated, rather than demonstrably false or misleading. But this reasoning would invalidate the very definitions of “drug” and “device” that undergird the entire FDCA. The majority also emphasizes that the prohibition on off-label promotion applies only to a “particular class of speakers”— namely, drug manufacturers. Maj. Op. at 39. But drug manufacturers are the precise group that the government must encourage to participate in the new drug approval process. Indeed, if the prohibition applied to any broader class of speakers, it would likely fail Central Hudson’s fourth requirement that a regulation be “narrowly drawn.” The Supreme Court’s decision in Sorrell is thus inapposite in the present circumstances. The statute there did not directly advance Vermont’s interest in protecting patient privacy because it applied to only a small subset of those groups that could possibly compromise patient privacy. See 131 S. Ct. at 2668. Drug manufacturers, in contrast, form the entirety of those speakers that could possibly undermine the new drug approval process by not participating in it. 22 Furthermore, allowing drug manufacturers to promote off-label uses would undermine the FDA’s approval process for not only new uses of pre-approved drugs, but also for entirely new drugs. As explained above, when determining whether a drug should be approved, the FDCA requires consideration not only of the drug’s safety, but also its effectiveness. See 21 U.S.C. § 355; United States v. Rutherford, 442 U.S. 544, 555 (1979) (“[T]he [FDA] Commissioner generally considers a drug safe when the expected therapeutic gain justifies the risk entailed by its use.”). If a drug manufacturer must be allowed to distribute a drug for any use so long as it is approved for one use, the government’s balancing of a drug’s benefits against its risks becomes very difficult or even impossible. Drugs viewed as safe for certain uses might be considered unsafe overall if the benefits and risks being weighed are not for a specific intended use but rather for any use at all, whether supported by evidence or not. The prohibition of off-label promotion is thus not simply a “paternalistic” attempt to shield physicians and patients from truthful information. See Maj. Op. at 40. Rather, it is a necessary tool for the effective functioning of a regulatory system that the Supreme Court has endorsed as legitimate. The majority implies that prohibiting off-label promotion is unconstitutionally “paternalistic” regardless whether the drug manufacturer’s claims are addressed to a physician or to a patient. See, e.g., Maj. Op. at 40 (“[P]rohibiting off-label 23 promotion by a pharmaceutical manufacturer while simultaneously allowing offlabel use ‘paternalistically’ interferes with the ability of physicians and patients to receive potentially relevant treatment information . . . .”) (emphasis added). But if drug manufacturers have a First Amendment right to distribute drugs for any use to physicians or even directly to patients, then the entire FDCA may well be unconstitutional. Prohibiting off-label promotion by drug manufacturers is also the least restrictive way of advancing the government’s interests. Although the majority asserts various alternatives, none would be similarly effective. A disclaimer system or required listing of intended uses would provide manufacturers much less incentive to submit their drugs for FDA approval, and in turn encourage promotion based on data much less reliable than the clinical investigations required under 21 U.S.C. § 355(d).7 A ceiling on off-label prescriptions would require collecting data from countless numbers of doctors and patients and, given the medical uncertainties involved, could needlessly (and simultaneously) result in the denial of some effective treatments and the overprescription of 7 Indeed, experts have concluded that most prescriptions for off-label use have little or no scientific support. See Randall S. Stafford, Regulating Off-Label Drug Use: Rethinking the Role of the FDA, 358 New Eng. J. Med. 1427, 1427 (2008) (“In an examination of off-label prescribing of 160 common drugs, off-label use was . . . found to account for 21% of all prescriptions, and most off-label drug uses (73%) were shown to have little or no scientific support.”) (citing David C. Radley, Stan N. Finkelstein & Randall S. Stafford, Off-Label Prescribing Among Office-Based Physicians, 166 Archives of Internal Med. 1021 (2006)). 24 ineffective and even dangerous ones. Finally, a ban on off-label prescriptions would be no better. Indeed, it would constitute an unprecedented intrusion into the practice of medicine, and would result in perhaps an even greater restriction on speech. See Central Hudson, 447 U.S. at 563–64 (government free to ban “commercial speech related to illegal activity”). And again, because a product’s very definition as a “drug” depends upon its intended use (which is often established by the manufacturer’s speech), it is unclear why the majority’s lessrestrictive-alternatives analysis is not equally applicable to the FDCA’s entire scheme of drug regulation. That the FDCA is both “content- and speaker-based” within the meaning of Sorrell, 131 S. Ct. at 2663, does not alter the foregoing analysis. Every commercial speech case, by its very nature, involves both content- and speakerbased speech restrictions. See Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 761 (1976) (“If there is a kind of commercial speech . . . it must be distinguished by its content.”). Yet the Supreme Court has long acknowledged—and acknowledged again in Sorrell—that “the government’s legitimate interest in protecting consumers from commercial harms explains why commercial speech can be subject to greater governmental regulation than noncommercial speech.” Sorrell, 131 S. Ct. at 2672 (internal quotation marks omitted). Indeed, the Supreme Court struck 25 down the ban on energy advertising in Central Hudson because a content-based less-restrictive alternative existed. See Cent. Hudson, 447 U.S. at 571 (“[T]he Commission could attempt to restrict the format and content of Central Hudson’s advertising. It might, for example, require that the advertisements include information about the relative efficiency and expense of the offered service, both under the current conditions and for the foreseeable future.”). Sorrell did not purport to overrule the Central Hudson test, which has guided First Amendment doctrine in this area for thirty years. Moreover, in Sorrell the Court noted that Vermont did not argue that its challenged statute “will prevent false or misleading speech.” 131 S. Ct. at 2672. Rather, Vermont’s “interest in burdening the speech of detailers instead turn[ed] on nothing more than a difference of opinion.” Id. In contrast, Congress intended the FDA approval process to prevent dangerous products with false or misleading labels from entering the market, and also to provide a base of reliable, objective information about prescription drugs that could help physicians and patients identify potentially misleading claims. Clearly this is the type of statute to which Sorrell intended that Central Hudson would still apply.8 8 Nor does the fact that 21 U.S.C. § 331(a) applies criminal penalties necessarily mean that it warrants heightened scrutiny. The case that the majority cites for this proposition, Holder v. Humanitarian Law Project, did not premise its application of 26 It is certainly true that the 'fear that people would make bad decisions if given truthful information' cannot justify content-based burdens on speech. Sorrell, 131 S. Ct. at 2670–71 (quoting Thompson, 535 U.S. at 374). But this does not mean that conveying non-demonstrably false information to consumers must take precedence over all competing government interests. Our system of drug regulation developed to protect consumers from misleading and unsubstantiated claims about drugs’ safety and efficacy, and the prohibition on off-label promotion by drug manufacturers is essential to maintaining the effectiveness of that system. Therefore, even if such a prohibition is considered a direct regulation of speech, it is a regulation that directly advances a substantial government interest in a manner not more extensive than necessary to serve that interest. I would thus find it constitutional under Central Hudson and Sorrell.