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January 26, 2017

FDA Releases Draft Guidance on Medical Product Communications Consistent with FDA-Required Labeling


Introduction and Overview

On January 17, 2017, among a string of key guidance documents regarding communications about medical products, the US Food and Drug Administration (FDA) issued a draft guidance entitled "Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers" (hereafter, the "Draft Guidance").1 This guidance addresses medical communications that present information that is not contained within the FDA-required labeling of a product but that is nonetheless "consistent with the FDA-required labeling." The Draft Guidance articulates how FDA will exercise its enforcement discretion for such communications if three key factors are met, as outlined below. The Draft Guidance also provides specific examples of the types of communications that it would consider to be "consistent with" the FDA-required labeling.2 Further, FDA offers general (but not comprehensive) recommendations to firms wishing to communicate information that is consistent with the FDA-required labeling in a truthful and non-misleading way.

FDA released this Draft Guidance along with two other very important documents that address product communications by manufacturers: (1) Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products;3 and (2) Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities—Questions and Answers.4 Comments for each guidance are due by April 19, 2017.5 Collectively, these documents set forth FDA's current positions on the First Amendment as it relates to manufacturer communications, though it is possible that the Trump Administration could take different positions and alter the approach taken in these documents.

FDA's Three-Factor Analysis

FDA outlines three factors that it will consider in determining whether a firm's communication about a medical product is "consistent" with the FDA-required labeling. These factors are as follows:

1. The communication must be consistent with FDA-required labeling as to: (i) the product's indication; (ii) the product's approved or cleared patient population; (iii) the use limitations or directions for handling, preparing, or using the product (as reflected in the FDA-required labeling); or (iv) the product's dosing and administration.

2. The communication should not make representations or suggestions that "increase the potential for harm to health relative to information in the FDA-required labeling." FDA does not put forth a single standard, but instead describes the use of product-specific analysis to determine potential for harm.

3. The directions for use in the FDA-required labeling must enable the product to be safely and effectively used under the conditions represented. Thus, the communication must not represent or suggest conditions under which this would not be the case.

The Draft Guidance also provides general examples of communications that, in FDA's view, do and do not meet the consistency requirement, as well as more specific hypotheticals (see pp. 11-14). FDA notes that such examples "are provided for illustrative purposes only and are not intended to be comprehensive or restrictive," and cautions that consistency determinations are "fact-specific" and "made by evaluating the particular representations or suggestions being made in a communication" using the three factors outlined above.6

Information That Could Be Consistent with FDA-Required Labeling

  • Information about the long-term safety and/or efficacy of products that are approved/cleared for chronic use (e.g., postmarketing information regarding safety and/or efficacy over 18 months when a product was approved based on 24-week study data).
  • Information about the effects or use of a product in specific patient subgroups that are included in its approved/cleared patient population (e.g., a firm's communication provides information on the number of female patients that were studied in its pivotal clinical trials and the treatment effects in that patient group, or, in the case of a diagnostic product, the diagnostic performance in that patient group).
  • Quantified onset or duration of action information regarding the product's efficacy.
  • Information based on a comparison of safety or efficacy of a medical product for its approved/cleared indication to another product that is approved/cleared for the same indication.

Other examples FDA includes that could be "consistent with" FDA-required labeling include: (1) additional context about adverse reactions; (2) information concerning the effects of a product that comes directly from the patient (i.e., patient-reported outcomes); (3) information about product convenience; and (4) additional context about a product's mechanism of action (MOA).

Information That is Not Consistent with FDA-Required Labeling

  • Information regarding a different disease, condition, or patient population (e.g., unapproved use).
  • Information regarding a different stage, severity, or manifestation of a disease (e.g., severe vs. mild).
  • Information regarding use of a product as monotherapy when it is only approved/cleared for use in conjunction with one or more other products or therapeutic modalities.
  • Information regarding a different strength, dosage, use regimen, dosage form, route of administration, or tissue type.

The Draft Guidance also reiterates FDA's longstanding position that communication of information about unapproved uses is only appropriate through unsolicited request responses and reprints.

Evidentiary Support for "Consistent" Communications and Best Practices for Developing "Consistent" Communications

The Draft Guidance clarifies that representations or suggestions in a firm's communication that are false or misleading in any particular could still misbrand a product and subject a manufacturer to enforcement action, regardless of whether the communication is consistent with FDA labeling. The Draft Guidance offers several recommendations about the types of evidentiary support that, in FDA's view, are required to substantiate communications that are consistent with FDA-required labeling as truthful and non-misleading. Importantly, these examples reflect a shift away from strict application of the "substantial evidence" test to a more flexible standard that rests on disclosure of context and material limitations on underlying study design. In this respect, the Draft Guidance is arguably closer to standards applied by the FTC to health product claims, as well as the PhRMA-BIO principles on responsible communications to health care professionals7 issued last Summer.

  • FDA reiterates that communications must reveal facts that are material about the product, including information about its risks, and be "grounded in fact and science and presented with appropriate context."
  • Data, studies, or analyses relied upon in communications should be "scientifically appropriate and statistically sound to support the representations or suggestions made in the communication."
  • Evidence presented in a communication should be "accurately characterized in the communication, including limitations of the strength of the evidence and the conclusions that can be drawn from it." However, FDA clarifies that if the underlying study is "inadequate to support the representations or suggestions it presents, disclosure of the material limitations of that study does not correct the misleading" nature of the communication.

The Draft Guidance suggests that FDA will "not consider representations or suggestions in a communication that is consistent with the FDA-required labeling to be false or misleading based only on the lack of evidence sufficient to satisfy the applicable approval/clearance standard" because the safety and effectiveness of the drug or device has "already been established by appropriate evidence during the premarket review process." However, the Draft Guidance asserts that a communication could be false or misleading for other reasons, including the following:

[C]ertain analyses of pivotal trial data may provide information that elaborates on the data reflected in the product's FDA-required labeling (e.g., information from separate analyses of the individual components of a composite endpoint that was successfully used as the primary endpoint and that are derived from appropriate statistical tests and pre-specified in the statistical analysis plan) However, if the pivotal trial was, for example, not adequately powered to determine treatment effect on the individual components of the composite endpoint and/or type 1 error (false positive rate) was not controlled for these analyses, these analyses would generally not support conclusions about a treatment effect of the product on the individual components of the composite endpoint. In such a case, representing or suggesting that the data support such efficacy conclusions, either directly . . . or indirectly . . . would be false or misleading."

Additionally, FDA offers several "high-level recommendations" that it believes manufacturers should consider in developing communications that are consistent with the FDA-required labeling. FDA's guidance in this regard is substantially similar to the guidance that the FTC has previously provided to advertisers, recommending for example that companies should evaluate express and implied claims, as well as the overall impression created by the communication as a whole. FDA also recommends that "before disseminating a communication regarding a medical product, firms should have qualified medical, legal, and regulatory personnel carefully review the communication to ensure it is not false or misleading." Notable recommendations include the following:

  • Manufacturers should accurately represent and disclose study results and data relied upon in a communication in a "clear and prominent manner," including: (1) "material aspects of study design and methodology … to allow audiences to accurately interpret the information (e.g., type of study, study objectives, product dosage/use regimens, controls used, patient population studied)"; and (2) "material limitations related to study design, methodology and results."
  • Communications should "accurately characterize and contextualize the relevant information about the product, including by disclosing unfavorable or inconsistent findings."
  • Communications should provide the audience with appropriate context (e.g., when providing postmarket information about the types and rates of occurrence of adverse events observed in practice, firms should also include information on adverse reactions observed in the clinical trials).

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FDA's Draft Guidance provides some clarity to manufacturers and related stakeholders to analyze when product communications may be "consistent" with the FDA-required labeling, particularly regarding use of sub-group, long-term, MOA, and convenience data. The Draft Guidance also sets forth a standard that is more consistent with the substantiation and enforcement standards applied to marketing for OTC drugs, as well as the PhRMA-BIO Principles noted above. Comments are due on the Draft Guidance by April 19, 2017.

In the interim, stakeholders should consider the implications of the Draft Guidance on their marketing and medical communications strategies, internal policies and procedures, promotional review processes (including related processes governing "data on file" and other data outside of the FDA-approved labeling used to substantiate promotional claims), and compliance programs more generally.

  1. See, FDA, Guidance for Industry, Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers (January 2017).

  2. The FDA-required labeling can include, for example, the FDA-approved prescribing information or patient labeling.

  3. See, FDA, Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (January 2017).

  4. See, FDA, Guidance for Industry and Review Staff, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers (January 2017). These documents come roughly one week after the Agency issued a final rule amending the "intended uses" regulation as part of a broader rulemaking focused on the circumstances in which a product made or derived from tobacco will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act. See 82 Fed. Reg. 2193 (Jan. 9, 2017).

  5. Draft FDAMA 114 Guidance (Docket No. FDA-2016-D-1307); First Amendment Memorandum (Docket No. FDA-2016-N-1149); and Consistent With Label Draft Guidance (Docket No. FDA-2016-D-2285).

  6. With respect to devices, FDA reminded industry to review the "consistent with" examples in "conjunction with the Agency's existing regulations, guidances, and policies, for example, regarding when a special control may trigger certain labeling requirements for a specific device type or when a modification to the indications for use of a device would trigger the need for a new premarket submission."

  7. See, BIO and PhRMA, "Principles on Responsible Sharing of Truthful and Non-Misleading Information About Medicines with Health Care Professionals and Payers."