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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
intended use would have a significant negative impact on public health. To protect consumers from dangerous products containing pharmacological ingredients like the cough suppressant in United States v. Johnson that caused several deaths, FDA intends to continue considering the full range of evidence relevant to determining intended use.
Comment 5 One comment agreed with the NPRM that evidence of intended use could include conduct other than claims, but suggested that the rule clarify that the conduct must be promotional.
Response FDA declines this suggestion. FDA believes that the key issue in the intended use analysis is whether the evidence is relevant, which does not necessarily depend on whether there is evidence of promotional activity. The NPRM
provided several examples to help inform the assessment of relevance. As the preamble explained, where a firm disseminates additional specific safety and warning information to healthcare providers to minimize the risk to patients receiving the drug for the unapproved usean example of nonpromotional speechFDA would not consider such evidence to be relevant to intended use see 85 FR 59718 at 59726. But the preamble provided other examples of evidence that would not necessarily be considered promotional that would still be relevant to intended usesuch as designing a stent to be specifically sized for a use that is different from the purported use see 85
FR 59718 at 59725. As another example, a factfinder might consider, as evidence of a new intended use, a spacer that the manufacturer claims can be used to elute one liquid, but is in fact designed with holes that are sized to elute a more viscous substance that contains a different active ingredient.
Accordingly, FDA declines the suggestion to include promotional as a limiting principle for non-claimsbased evidence that may be relevant to intended use.
This conclusion is consistent with recent case law. The case law describes the standard for determining intended use as all relevant evidence. This allows the fact finder to evaluate the facts of the specific case, which may involve a variety of situations and circumstances. For example, in United States v. Carlson, 810 F.3d 544 8th Cir.
2016, defendants owned and/or worked at the Last Place on Earth, a head shop in Duluth, Minnesota, which sold synthetic drugs, such as synthetic marijuana. The products were labeled as incense, herbal incense, herbal potpourri, bath salts, etc., and also bore
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the label statement not for human consumption, but defendants knew that customers purchased them to consume as drugs see id. at 549; see also Amended Superseding Indictment, 12cr00305DSDLIB 9 D. Minn.
September 11, 2013. The trial court instructed the jury that the products intended use is what a reasonable person would conclude the manufacturer, seller or dispenser of the product intended the product to be used for, based on all of the relevant information see The Courts Instructions to the Jury, 12cr00305
DSDLIB at 58 D. Minn. October 8, 2013. The court explained that the jury could consider any and all testimony and evidence, whether or not the manufacturer, seller, or dispenser made contrary claims or no claims see id. at 5859. All of the defendants were convicted of distributing misbranded drugs in violation of the FD&C Act see Carlson, 810 F.3d at 550.
In United States v. Dessart, 823 F.3d 395 7th Cir. 2016, the defendant used a website to sell products containing human growth hormone HGH, steroids, and the active ingredients in the prescription drugs VIAGRA
sildenafil, CIALIS tadalafil, and LEVITRA vardenafil. Id. at 398. The website said that the products were for research only. Id. The defendant was indicted on 23 counts of violating the FD&C Act. Id. at 399. The court instructed the jury: You should consider what a reasonable person would conclude the manufacturer or seller of the product intended the product to be used for, based on all of the relevant information. . . . You are not bound by any claims or statements made by the manufacturer or seller if there is other evidence concerning the use intended by the manufacturer or seller that conflicts with those claims or statements. Jury Instructions, Case No.
12CR85 at 45 E.D. Wis. June 19, 2014. The jury convicted on all counts.
Dessart, 823 F.3d at 400.
In United States v. 789 Cases of Latex Surgeons Gloves, 799 F. Supp. 1275, 12941295 D.P.R. 1992, the Government sought condemnation of surgeons gloves and their components, including cornstarch, stored in a rodentinfested facility. Although the product manufacturer argued that it did not intend for the gloves to be used in medical procedures, the court found that the circumstances surrounding the manufacture, distribution, and actual use of Plastic Materials gloves present overwhelming evidence that claimants gloves are intended for use asand therefore aredevices within the meaning of the Act: e.g., the sole
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customer, the United States, purchased gloves only for medical use; and the cornstarch used to store the gloves was of a type used only with gloves intended for medical procedures.
In each of these cases, restricting relevant evidence to promotional claims and conduct could have led the factfinder to conclude that the products were outside of FDAs jurisdiction.
Comment 6 One comment asserted that the phrase any relevant evidence as used in the case law should be understood, under the statutory interpretation principle ejusdem generis, to refer only to evidence of promotional claims.
Response FDA disagrees. First, most obviously, principles of statutory construction are not typically applied to language in court decisions. Second, throughout this preamble, we have cited numerous examples where courts and FDA have considered evidence other than promotional claims to be relevant to establishing intended use.
C. Comments and Responses Regarding the Design or Composition of an Article Comment 7 Several comments stated that FDA should reconsider the proposed regulatory text identifying evidence about the design or composition of an article as a type of evidence relevant to establishing intended use. Some comments also asserted that the characteristics and design of a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification do not determine intended use and that intended use does not depend on the design of the product. Some comments requested that FDA remove this phrase from the codified language describing the types of evidence relevant to determining a products intended uses.
Response We disagree with the comments and decline to remove design or composition from the codified language. As explained in the preamble, the revisions to the intended use regulations do not reflect a change in FDAs policies and practices. Rather, the amendments to the intended use regulations are intended to describe the types of evidence relevant to determining a products intended use based on FDAs current practices. The design and composition of an article are examples of the types of evidence that may be relevant when determining the articles intended use. For example, FDA may consider the design or composition of a product, which includes product characteristics, when determining whether the product is intended to affect the structure or any
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