October 27, 2020

Volume X, Number 301

Advertisement

October 27, 2020

Subscribe to Latest Legal News and Analysis

October 26, 2020

Subscribe to Latest Legal News and Analysis

FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule

On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” Proposed Rule to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4 and with the intent to clarify that how healthcare providers (HCPs) prescribe or use a product cannot be the sole basis for determining intended use. Comments on the Proposed Rule must be submitted to FDA by October 23, 2020.

IN DEPTH


On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The Proposed Rule would amend FDA’s regulations regarding the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act or Public Health Service Act and FDA’s implementing regulations for intended use. With the Proposed Rule, FDA intends to clarify that how healthcare providers (HCPs) prescribe or use a product cannot be the sole basis for determining intended use, a nod to the fact FDA does not regulate the practice of medicine and the fact that HCPs frequently use medical products off-label, or outside the manufacturer’s cleared or approved intended use, in their professional judgment.

Specifically, FDA proposes to:

  • Delete the last sentence of 21 C.F.R. § 201.128 and 801.4, respectively, and to insert a new clause stating “provided, however, that a firm would not be regarded as intending an unapproved new use for an [approved or cleared medical product] based solely on that firm’s knowledge that such [product] was being prescribed or used by health care providers for such use.”

  • Amend the text of these regulations to provide additional clarification regarding the types of evidence that the agency may deem relevant in determining a product’s intended use.

  • Insert in these regulations a reference to 21 C.F.R. § 1100.5, which describes when a product made or derived from tobacco that is intended for human consumption will be regulated as a drug, device or combination product to clarify the interplay between the drug/biologic and device intended use regulations, respectively, and FDA’s tobacco product regulations.

21 C.F.R. § 201.128

21 C.F.R. § 801.4

The words intended uses or words of similar import in 201.5, 201.115, 201.117, 201.119, 201.120, and 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of drugs an article (or their representatives). The intent is determinedmay be shown by such persons’ expressions, the design or composition of the article, or may be shownby the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intentIt may be shown by thecircumstances thatin which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm’s knowledge that such drug was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the drugarticle, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.

The words intended uses or words of similar import in 801.5, 801.119, and801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of devices an article (or their representatives). The intent is determined may be shown by such persons’ expressions, the design or composition of the article, or may be shown by the circumstances surrounding the distribution of the article. Objective intentIt may be shown by thecircumstances thatin which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved or cleared device based solely on that firm’s knowledge that such device was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the devicearticle, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

In the preamble to the Proposed Rule, FDA included other examples of evidence that it does not consider to be determinative of intended use, standing alone:

  • Limited instances where a firm disseminates safety information about unapproved uses to HCPs to minimize risks to patients

  • A manufacturer’s official social media account “following” other social media accounts that relate to uncleared or unapproved indications, provided the manufacturer does not comment or endorse any specific posts on the other social media accounts

  • Internal sales figures related to uncleared or unapproved uses

  • Corporate filings or submissions to the Securities and Exchange Commission that include required disclosures of development activities or potential actual sales for uncleared or unapproved uses

  • Summaries of aggregated clinical trial results provided to trial subjects to acknowledge their contributions, provided summaries are factual, balanced and complete presentations of trial results and do not make any conclusions about the safety or effectiveness of the uncleared or unapproved product or use and contain conspicuous and prominent statements that the product or use has not been cleared, approved or licensed by FDA.

However, the agency reaffirmed its longstanding position that the intended use of a product can be evaluated based on “any relevant source of evidence,” including direct and circumstantial evidence. This may include a product’s labeling, express or implied promotional claims, advertising and any other relevant evidence. This may include consumer intent if it is relevant to demonstrating the seller’s intent, training programs, financial arrangements, and other circumstances surrounding the manufacture, distribution, promotion or sale of a product. FDA provided a list of potentially relevant evidence in the preamble to the Proposed Rule, including:

  • Express claims or representations

  • Implied claims (including suggestive names and representations that the product contains a particular ingredient to imply a physiological effect)

  • Product characteristics and design (including known physiological effects, known uses, and design or technical features)

  • Circumstances of sale or distribution (circumstances and context surrounding the sale, and to whom and for whom the products are offered).

Rulemaking Background

The Proposed Rule, if finalized, would have the effect of repealing and replacing portions of FDA’s January 9, 2017 final rule (2017 Final Rule), “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’” (82 Fed. Reg. 2193, 2196 (Jan. 9, 2017), first proposed in 2015 (2015 Proposed Rule).

Whereas, in the 2015 Proposed Rule, FDA proposed to strike the last sentence of 21 C.F.R. §§ 201.128 and 801.4, respectively, in the 2017 Final Rule, FDA amendedthe last sentence of these respective regulations to clarify that the agency, absent “extraordinary circumstances,” would not consider a manufacturer as intending an uncleared or unapproved new use for a device based solely on the manufacturer’s knowledge that the product was being used or prescribed by doctors for such use. Rather, under the 2017 Final Rule, a manufacturer was not obligated to provide adequate labeling for that uncleared or unapproved use unless the totality of the evidence showed the manufacturer intended for its device to be used for that use.

However, the agency received an industry petition to stay and for reconsideration, which raised concerns that the amended language did not make clear that a manufacturer’s mere knowledge of an unapproved new use would not automatically trigger requirements for new labeling (that would, in turn, render distribution of that approved product unlawful without a new or supplemental marketing authorization). As a result, the agency delayed the 2017 Final Rule’s effective date and reopened the comment period to allow further consideration of the substantive issues raised in additional comments. As a result, with respect to the “intended use” definitions, the Proposed Rule essentially reflects a reversion to the 2015 Proposed Rule.

Comments on the Proposed Rule may be submitted to Docket FDA-2015-N-2002 by October 23, 2020.

© 2020 McDermott Will & EmeryNational Law Review, Volume X, Number 269
Advertisement

TRENDING LEGAL ANALYSIS

Advertisement
Advertisement

About this Author

Anisa Mohanty, McDermott Law Firm, Health Care Attorney
Associate

Anisa Mohanty advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing Practice (cGMP) and Quality System requirements. Anisa also assists clients with US Food and Drug Administration (FDA) engagement strategies and responding to FDA administrative and enforcement actions. 

202-756-8286
Vernessa Pollard Pharmaceutical Attorney McDermott
Partner

    Vernessa T. Pollard is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C., office. Vernessa serves as co-head of the Firm’s Food and Drug Administration (FDA) practice.

    Vernessa advises companies on regulatory, compliance, enforcement and legislative matters involving pharmaceuticals, medical devices, digital and mobile health, health IT solutions and services, and emerging technologies and software. She also advises national and international food and cosmetic producers and retailers on regulatory and compliance issues related to food and cosmetic marketing and safety.

    Vernessa regularly counsels companies on product approvals and premarket strategy, Good Manufacturing Practice (GMP) and Quality System (QS) requirements, advertising and promotion, adverse event reporting, FDA Warning Letters, FDA inspections, recalls, import detentions and corporate compliance programs. She has represented companies and executives in FDA and Department of Justice (DOJ) investigations and enforcement matters. She also conducts due diligence evaluations and analyses of FDA regulatory issues relating to mergers and acquisitions.

    202-756-8181
    Brian J. Malkin Biotech Lawyer McDermott Will & Emery Law Firm
    Partner

    Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.

    ...

    202-756-8045
    Michael Ryan Attorney specializing in Pharma law McDermott Law Firm
    Partner

    Michael W. Ryan is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.

    Michael focuses his practice on the legal, regulatory and reimbursement issues that manufacturers and investors encounter in the development and commercialization of pharmaceuticals, medical devices, biotechnology products and laboratory services.  Michael counsels entities as they seek to obtain authorization to market their products from the U.S. Food and Drug Administration, maintain compliance with applicable laws and regulations (including the...

    +1 202 756 8088
    Associate

    Gugan Kaur advises life sciences clients on Food and Drug Administration (FDA) regulatory, compliance and enforcement issues. She provides counsel on matters throughout the product development process, including clinical trials, labeling and advertising, post-marketing, FDA inspections, and compliance and enforcement actions. She also advises clients on potential Federal Trade Commission (FTC) issues related to FDA-regulated products. Gugan has experience assisting clients in submitting trade complaints to FDA, FTC, the National Advertising Division (NAD) and the Electronic Retailing Self-...

    1 202 756 8890
    Advertisement
    Advertisement