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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
death. FDA has not approved any liquid silicone products for injection to augment tissues anywhere in the body.
Therefore, it was in the interest of public health for FDA to take action against the person responsible for the administration of these products, and such action was well within FDAs jurisdiction and permissible under the First Amendment.
There are many industries whose operations involve some amount of communication with the public. The fact that those communications may be truthful does not shield those industries operations from Government regulation. It has never been deemed an abridgment of freedom of speech . . .
to make a course of conduct illegal merely because the conduct was in part initiated, evidenced, or carried out by means of language, either spoken, written, or printed Rumsfeld v. Forum for Academic and Institutional Rights, Inc., 547 U.S. 47, 62 2006 citation omitted. And, as the Court recently confirmed, the First Amendment does not prevent restrictions directed at commerce or conduct from imposing incidental burdens on speech Barr v.
Am. Assn of Political Consultants, 140
S. Ct. 2335, 2347 2020 quoting Sorrell v. IMS Health Inc., 564 U.S. 552, 567
2011.
Thus, as we explained in the NPRM, courts have long upheld the premarket review requirements of the FD&C Act and the PHS Act, and the role of intended use within that framework, as necessary to promote and protect the public health and as fully consistent with the First Amendment see 85 FR
59718 at 59723. More specifically, courts have held that, under the holding of Wisconsin v. Mitchell, 508 U.S. 476, 489 1993, the Governments reliance on speech as evidence of intended use under the FD&C Act does not infringe the right of free speech under the First Amendment see, e.g., Whitaker v.
Thompson, 353 F.3d 947, 953 D.C. Cir.
2004; Nicopure Labs, LLC v. FDA, 944
F.3d 267, 283 D.C. Cir. 2019; United States v. Cole, 84 F. Supp. 3d 1159, 1166 D. Or. 2015; United States v.
Regenerative Sciences, LLC, 878 F.
Supp. 2d 248, 25556 D.D.C. 2012, affd, 741 F.3d 1314 D.C. Cir. 2014;
United States v. Livdahl, 459 F. Supp.
2d 1255, 1268 S.D. Fla. 2005; United States v. Lane Labs-USA, Inc., 324 F.
Supp. 2d 547, 57980 D.N.J. 2004; see also United States v. Article of Drug Designated B-Complex Cholinos Capsules, 362 F.2d 923, 927 3d Cir.
1966; United States v. General Nutrition, Inc., 638 F. Supp. 556, 562
W.D.N.Y. 1986. Indeed, reliance on
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speech as evidence of intent is common in the law.2
Third, as also explained in the NPRM, even if this rulemaking or regulatory regime were appropriately subject to First Amendment review, FDAs consideration of speech as one type of evidence of intended use under its statutory and regulatory framework easily satisfies any applicable test.
Under the Central Hudson framework, the threshold question is whether the speech is false or inherently or actually misleading or concerns unlawful activitysuch speech may be prohibited see Central Hudson Gas &
Elec. Corp. v. Pub. Serv. Commn, 447
U.S. 557 1980; In re R.M.J., 455 U.S.
191, 203 1982; 44 Liquormart, Inc. v.
Rhode Island, 517 U.S. 484, 497 n.7
1996; 1800411Pain Referral Serv., LLC v. Otto, 744 F.3d 1045, 1056 8th Cir. 2014. When commercial speech relates to an illegal activity, there is no First Amendment interest to weigh against the governmental interest supporting the regulation of commercial activity Pittsburgh Press Co. v. Human Relations Commn, 413 U.S. 376, 389
1973. Regulated parties cannot be allowed to escape reasonable Government regulations by bootstrapping themselves into the heightened scrutiny of the First Amendment simply by infusing the prohibited conduct with some element of speech Ford Motor Co. v. Tex. DOT, 264 F.3d 493, 506507 5th Cir. Tex.
2001.
For example, in United States v.
Caputo, 517 F.3d 935 7th Cir. 2008, the court found that it did not need to resolve the question of whether promotional claims for an approved medical device were protected by the First Amendment because defendants product was not approved: there was no lawful activity for speech to promote id. at 941. In United States v. Cole, 84 F. Supp. 3d 1159 D. Or.
2015, defendants distributed unapproved products with claims that they treated diseases, including Alzheimers and HIV infection. The court rejected defendants First 2 See Reference 16 This pattern in the law using intent as the predicate for regulation and then using speech as evidence of intentis quite common, and not peculiar to pharmaceutical regulation. As early as 1888, the Supreme Court affirmed a state court criminal conviction for someone who manufactured an oleaginous substance otherwise perfectly legal, except that he intended for it to be used as food, and thereby his manufacture of it fell under the purview of a state regulator. Similarly, a hollow piece of glass with a bowl on the end is illegal drug paraphernalia only if intended for such illicit uses. An automobile is not subject to regulation by the Federal Aviation Administration, unless it is intended to be used for flight in the air. citations omitted.

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Amendment defense, explaining that, because defendants speech concerns an illegal activitythe introduction into interstate commerce of unapproved new drugs, . . . the First Amendment is not violated id. at 116667. In United States v. LeBeau, 2016 U.S. Dist. LEXIS
13612 E.D. Wisc. February 3, 2016, the court similarly rejected defendants First Amendment defense to a charge of distributing an unapproved new drug and explained that, because defendants speech occurred while promoting and distributing a product that was intended for treatment of diseases and had not been approved by the FDA, his commercial speech did not concern lawful activity and did not pass step 1
of Central Hudson see id. at 29. The Seventh Circuit affirmed, explaining that because LeBeaus statements promoted the unlawful sale of an unapproved drug, they were not entitled to protection United States v. LeBeau, 654 Fed. Appx 826, 831 7th Cir.
2016.
Even where the threshold step of Central Hudson does not apply, FDAs reliance on speech as evidence of intended use in the context of premarket review directly advances, and is appropriately tailored to achieve, substantial public health interests and therefore satisfies the remaining steps of the Central Hudson analysis. The medical products FDA regulates have the potential to adversely impact public health and safety. The premarket review requirements of the FD&C Act and the PHS Act require companies to conduct scientific research to determine the safety and effectiveness of medical products before they are marketed and provide mechanisms to help ensure that protections are in place that will allow the public to obtain the benefits of these products while mitigating the risks.
Accordingly, these premarket review provisions do not ban manufacturers from making accurate claims but instead require them to substantiate such claims. Nicopure Labs, LLC v.
FDA, 944 F.3d 267, 285 D.C. Cir. 2019.
Comment 11 One comment asserted that the NPRM failed to provide a meaningful explanation of how its consideration of speech as evidence of intended use comports with the Central Hudson test, particularly whether there are any less speech-restrictive alternatives with respect to speech regarding unapproved uses of approved products. The comment cites United States v. Caronia, 703 F.3d 149 2d Cir.
2012 and criticizes the Government for not providing a sufficient explanation of its consideration of less-restrictive alternatives in the context of that lawsuit. Another commenter similarly
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