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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations asserted that the NPRM did not adequately justify under Central Hudson the Governments policy regarding off-label use/promotion.
Response Again, as noted above and in the NPRM, we do not believe this rulemaking implicates the First Amendment, particularly given that the changes to the codified language proposed and finalized in this rulemaking do not directly involve speech. As further explained in the NPRM, because intended use is only one element of an alleged violation of the FD&C Act, this rule does not itself implicate the First Amendment and does not attempt to resolve all First Amendment arguments that might be made by a firm in defending against an enforcement action under the FD&C
Act. 85 FR 59798 at 59723 n.5.
Nevertheless, in another proceeding, FDA has addressed in detail the issues raised by these comments see Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products January 2017 Ref. 17. Rather than repeat that analysis here, we summarize it briefly and incorporate the relevant portions of the document. The memorandum describes in detail the public health interests underlying and advanced by FDAs consideration of communications regarding unapproved uses of medical products that are approved, cleared, granted marketing authorization, or exempted from premarket notification as relevant to the premarket review requirements of the FD&C Act and PHS
Act see Ref. 17 at 316. As the memorandum explains, those requirements, among other things, motivate the development of scientific evidence that enables the reliable, population-level determination of the safety and efficacy of medical products for each intended use; require that the evidence be developed and independently reviewed before the products are marketed to the general public for each intended use; and require that the product bear labeling that identifies each medical use of the product that is approved, cleared, granted marketing authorization, or exempted from premarket notification and provides information for healthcare providers and patients on using the product safely and effectively for those uses that are approved, cleared, granted marketing authorization, or exempted from premarket notification. In the memorandum, FDA also examined alternative approaches suggested by the
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court in United States v. Caronia, as well as by commentators see id. at 26
34. FDA explained that, although many of these proposed approaches addressed one or more of the interests served by the premarket review requirements, FDA found that none of them integrated the complex mix of numerous interests at play and thus none of the proposed approaches best advanced those multiple interests see id..
Comment 12 One comment asserted that the right of a manufacturer to convey truthful and non-misleading information is protected under Thompson v. Western States Medical Center, 535 U.S. 357 2002.
Response We disagree with the suggestion that Western States shields truthful and non-misleading speech from Government regulation. In that case, the Court applied the Central Hudson test to evaluate the regulation of the speech at issue, 535 U.S. at 36877.
In an analysis that broke no new ground id. at 368, the Court explained that, in general, the Government should not restrict the communication of truthful and nonmisleading information for the sole purpose of preventing members of the public from making bad decisions with the information see id. at 374.
However, that rationale is not applicable to this rulemaking because the premarket review requirements of the FD&C Act and PHS Act advance several different Government interests in protecting public health, as discussed above see also Ref. 17.
Comment 13 One comment asserted that the First Amendment protects not only the right to speak freely but also the right to hear and receive valuable information, and that this interest is particularly acute for the audience of physicians.
Response FDA has recognized that, under certain circumstances, both healthcare providers and patients may be interested in information about unapproved uses of products see Ref.
17 at 17. In part because of this consideration, FDA has issued guidance documents describing circumstances in which the Agency does not intend to object to a firms product communications or to view such communications as evidence of a new intended use see 85 FR 59718 at 59723
& n.7. Nothing in this final rule reflects a change in FDAs policies and practices, as articulated in various guidance documents, regarding the types of firm communications that ordinarily would not, on their own, establish the firms intent that a medical product that is approved, cleared, granted marketing authorization, or
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exempted from premarket notification be used for an unapproved use. As discussed elsewhere in this preamble, FDA declines the suggestion to expand the scope of this rulemaking to additional subjects.
Comment 14 One comment referenced for support a 1999 district court decision in a case brought by Washington Legal Foundation. Another comment referenced the same litigation and asserted that FDA is subject to a permanent injunction curtailing the Agencys authority to bar manufacturers from sharing peer-reviewed medical texts and journal articles about off-label uses of their FDA-approved products.
Response We believe these comments have little bearing on the current rulemaking. First, as explained in the NPRM, the proposed revisions to the intended use regulations do not reflect any change in FDAs policies and practices, as articulated in various guidance documents, regarding the types of firm communications to which the Agency does not intend to object or to view as evidence of a new intended use. Among the guidance documents describing these existing policies are several that relate to the distribution of peer-reviewed medical texts and journal articles see 85 FR 59718 at 59723 &
n.7. Second, with respect to the district court decision referenced in the comments, the D.C. Circuit vacated the district courts decisions and injunctions insofar as they declare the FDAMA and the CME Guidance unconstitutional see Washington Legal Found. v. Henney, 202 F.3d 331, 337
D.C. Cir. 2000; see also Washington Legal Found. v. Henney, 128 F. Supp.
2d 11, 15 D.D.C. 2000 holding that injunction has been wholly vacated by the Court of Appeals; id. holding that Court of Appeals vacated all of this Courts previous constitutional rulings on the matter; 65 FR 14286 2000
describing FDAs understanding of the outcome of the Washington Legal Found. litigation; Letter from Margaret M. Dotzel, Assoc. Commissioner for Policy, FDA to Daniel J. Popeo &
Richard A. Samp, Wash. Legal Found., Docket No. 01P0250 January 28, 2002
same.
Comment 15 Some comments asserted that content-based restrictions on commercial speech are subject to strict scrutiny or heightened scrutiny.
One comment argued that Sorrell v. IMS
Health Inc., 564 U.S. 552 2011, Reed v. Town of Gilbert, 135 S. Ct. 2218
2015, Matal v. Tam, 137 S. Ct. 1744
2017, and Barr v. Am. Assn of Political Consultants, 140 S. Ct. 2335
2020 support the proposition that all content-based speech restrictions, even
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