United States: FDA Releases Draft Guidance On Medical Product Communications Consistent With FDA-Required Labeling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guidance documents regarding communications about medical products, the US Food and Drug Administration (FDA) issued a draft guidance entitled "Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers" (hereafter, the "Draft Guidance").1 This guidance addresses medical communications that present information that is not contained within the FDA-required labeling of a product but that is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 The Draft Guidance articulates how FDA will exercise its enforcement discretion for such communications if three key factors are met, as outlined below. The Draft Guidance also provides specific examples of the types of communications that it would consider to be "consistent with" the FDA-required labeling.2 Further, FDA offers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FDA released this Draft Guidance along with two other very important documents that address product communications by manufacturers: (1) Memorandum: Public Health Interests and First Amendment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).

*              *              *

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."

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions