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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
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States v. Caronia, 703 F.3d 149 2d Cir.
2012 to foreclose that position. Another comment similarly argued that the NPRM understated the meaning and impact of Caronia.
Response We disagree. As we explained in the NPRM, the Second Circuit has explicitly confirmed contrary to the cited conclusion in Amarinthat Caronia left open the governments ability to prove misbranding on a theory that promotional speech provides evidence that a drug is intended for a use that is not included on the drugs FDAapproved label. United States ex rel.
Polansky v. Pfizer, Inc., 822 F.3d 613
n.2 2d Cir. 2016. And the Second Circuit has more generally confirmed the continued viability of the Wisconsin v. Mitchell theory after Caronia, finding a First Amendment challenge to reliance on speech to show an element of violation meritless because the speech is not itself the proscribed conduct. United States v. Pierce, 785
F.3d 832, 841 2d Cir. 2015 quoting Caronia, 703 F.3d at 161. It is also noteworthy that the first comment did not cite any case other than Amarin, a district court decision on a motion for a preliminary injunction, in support of its position limiting the application of Wisconsin v. Mitchell. Indeed, decisions from other circuits issued after Caronia have upheld the application of Wisconsin v. Mitchell in the context of the premarket review requirements of the FD&C Act see Nicopure Labs, LLC
v. FDA, 944 F.3d 267, 283 D.C. Cir.
2019; United States v. Lebeau, 654 Fed.
Appx 826, 83031 7th Cir. 2016;
United States v. Facteau, 2020 U.S. Dist.
LEXIS 167169 D. Mass. September 14, 2020; United States v. Cole, 84 F. Supp.
3d 1159, 1166 D. Or. 2015.
E. Comments and Responses Regarding the Fifth Amendment Comment 19 Some comments questioned the constitutionality of the intended use regulations and asserted that the Fifth Amendment requires that the boundaries between permissible and impermissible communications be clearly drawn, particularly with respect to matters involving speech. One comment criticized FDAs reliance on guidance documents to describe its enforcement policies in this regard.
Response While FDA agrees that laws must give a person of ordinary intelligence a reasonable opportunity to know what is prohibited, meticulous specificity is not required see Grayned v. City of Rockford, 408 U.S. 104, 110
1972. The Supreme Court has recognized that laws may embody flexibility and reasonable breadth see
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id. and officials implementing them may exercise considerable discretion see Ward v. Rock Against Racism, 491
U.S. 781, 794 1989, without the laws being declared unconstitutionally vague.
More specifically, the Supreme Court has held that perfect clarity and precise guidance have never been required even of regulations that restrict expressive activity see Ward, 491 U.S.
at 794 citations omitted. It is also well established that the use of an intent standard does not render a statute unconstitutionally vague see United States v. Williams, 553 U.S. 285, 306
2008; Natl Assn of Manufacturers v.
Taylor, 582 F.3d 1, 26 D.C. Cir. 2009
an intent standard is not per se vague, even in a statute regulating speech.
Indeed, absent special circumstances not present here, there is no reason to conclude that the every day task of assessing intent is inherently vague even when protected speech is involved see Taylor, 582 F.3d at 27.
Moreover, courts have repeatedly rejected due process challenges to the FD&C Act as unconstitutionally vague or ambiguous. In United States v.
Hohensee, 243 F.2d 367 3d Cir. 1957, the Third Circuit rejected an unconstitutional vagueness challenge to provisions of the FD&C Act, which included the determination of intended use. In upholding the provisions, the court relied in part on the Supreme Court determination that the FD&C Act should be given a liberal interpretation to effectuate its high purpose of protecting unwary consumers in vital matters of health see id. at 370; see also United States v. Sullivan, 332 U.S.
689, 695 1948 rejecting due process challenge to FD&C Act and finding no ambiguity in the misbranding language;
United States v. Caputo, 517 F.3d 935, 941 7th Cir, 2008 rejecting argument that line between new and modified devices is too vague to be enforceable;
V.E. Irons v. United States, 244 F.2d 34, 45 First Cir. 1957 rejecting as untenable the claim that the FD&C
Acts misdemeanor misbranding provisions are unconstitutionally vague and upholding misbranding conviction for distribution of vitamin and mineral products shown to be intended for use as drugs.; United States v. General Nutrition, Inc., 638 F. Supp. 556, 564
W.D.N.Y. 1986 The Act on numerous occasions has been upheld against vagueness challenges . . . and this Court is unaware of any case holding any provision of the Act void for vagueness in any circumstance.
citations omitted.
The first FDA regulation describing how intended use is determined was
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issued in 1952 see 17 FR 6818, 6820
1952 Ref. 1, and there have been only minor amendments since that time, including those being made through this rulemaking. Over nearly seven decades, medical product manufacturers have shown little difficulty in understanding how the regulations are applied. And, as noted in the NPRM, FDA has issued several guidance documents that describe 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 85 FR 59718 at 59723. FDA issues these guidance documents to better inform stakeholders regarding its policies, and feedback from stakeholders has generally been positive. The NPRM also goes further than previous rulemakings related to these regulations in providing illustrative examples of types of evidence that would and would not be relevant to establishing intended use.
Accordingly, we do not believe that the intended use regulations are unconstitutionally vague.
F. Comments and Responses Regarding Definitions Comment 20 Some comments suggested clarifying and defining the terms intended use and indications for use as these terms are used for devices in 801.4. One comment suggested defining these terms by adopting definitions used in other FDA
regulations and guidance documents.
The comment also suggested clarifying the definitions of intended use and indications for use as part of a substantial equivalence determination for a device and distinguishing these terms from the intended use regulations for drugs.
Response FDA disagrees with these comments. The intended use regulations, including 801.4, describe the types of evidence relevant to determining a products intended uses under the FD&C Act, the PHS Act, and FDAs implementing regulations. The term indications for use is not used in this rulemaking and as such, FDA does not believe there is a need to define the term here. Further, FDAs substantial equivalence determination during its review of a premarket notification is beyond the scope of this rulemaking.
Comment 21 Several comments suggested revising 801.4 to expressly include devices that are legally marketed without approval or clearance, such as devices exempt from premarket notification and granted marketing authorization. Some comments asserted that the terms approved or cleared medical products and approved or
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