United States: FDA Issues Final Guidance Documents Relating To Medical Product Manufacturer Communications

On June 12, 2018, the Food and Drug Administration ("FDA") issued two key documents outlining the agency's current thinking regarding drug and device manufacturers' communication of information not contained in product labeling. In particular, FDA issued final guidance documents laying out the agency's position with respect to (1) manufacturer communications with payors, formulary committees, and similar entities ("the Payor Guidance"), and (2) manufacturer communications consistent with FDA-required labeling ("the Consistent with the Labeling Guidance"). These guidance documents are the final versions of draft guidance documents issued on January 18, 2017, as previously reported by Ropes & Gray. The changes to the guidance documents are extensive, but generally provide additional flexibility for manufacturers to convey certain types of product information.

In announcing the final guidance documents, Commissioner Gottlieb emphasized his hope that "these two guidances will provide clarity to companies as they develop communications about their medical products and help ensure that patients, providers and insurers have access to a range of relevant, truthful and non-misleading information from companies about medical products." He also emphasized that the new guidance documents aim to "facilitate contracting for new medical products . . . based on the value that these products are delivering to health systems, providers, and especially patients."

FDA issued the Payor Guidance in response to a request from the Medical Information Working Group ("MIWG"), an ad hoc coalition of drug and device manufacturers co-represented by Ropes & Gray. MIWG and other industry groups have long urged FDA to clarify and modernize its regulations and policies on a range of topics relating to manufacturer communications, building on recent First Amendment case law emphasizing that the Constitution constrains FDA's ability to restrict manufacturers' communication of truthful, non-misleading information about their products, regardless of whether the information appears in the product labeling. In both guidance documents, FDA acknowledges that there is a variety of information not contained in product labeling that is nevertheless valuable to payers, prescribers, and patients. Below, we summarize the key changes from the draft guidance documents and discuss implications for product manufacturers.

Final Guidance on Payor Communications

  • The Payor Guidance provides additional context about the role of payors, formulary committees, and similar entities, as well as the types of information that these parties consider. For example, the Payor Guidance acknowledges that payors in certain cases will need to look to information that is different from what FDA would consider as part of the product approval process. The Payor Guidance also stresses that, because payors and other similar entities make coverage and reimbursement decisions that impact many patients, it is vital that the information provided be truthful and non-misleading and include appropriate background and contextual information.
  • The draft version of the Payor Guidance would have created a safe harbor for manufacturers to convey information only about investigational products with payors, formulary committees, or similar entities (collectively, "payors") prior to FDA approval. The final version expands the safe harbor for preapproval communications to cover new uses of legally marketed products, removing a restriction that could have sharply limited the information manufacturers could provide about the value of their products. 
  • The draft version of the Payor Guidance also provided recommendations for drug manufacturers' communications with payors about health care economic information ("HCEI"), but was silent on the guidance's applicability to device manufacturers. The final version states that the recommendations relating to HCEI communications are applicable both to drug and device manufacturers. 
  • The Payor Guidance reiterates the earlier view that it does not apply to the provision of information to individual health care professionals ("HCPs"). However, the final version also includes new and helpful language clarifying that if an individual serves both as an HCP and on a formulary committee (or in a similar role), the provision of HCEI to that individual when the individual is acting in his or her capacity as a formulary committee member would be within scope of the Guidance. 
  • The Payor Guidance provides several new examples setting forth types of HCEI communications that are or are not appropriate. For example, the Payor Guidance states that it may be appropriate to base an HCEI communication on a dataset that includes both patients who are within the indicated patient population and patients who are outside of the indicated patient population.
  • In general, the Payor Guidance provides greater flexibility and clarity with respect to the types of disclosures and contextual information that manufacturers should provide to payors in connection with HCEI. For example, FDA provides a list of disclosures that it believes are "generally material" to HCEI communications but expressly acknowledges that not all disclosures are required in all cases.
  • The Payor Guidance now explicitly states that "FDA does not regulate the terms of contracts between firms and payors, and such contracts are not subject to FDA reporting requirements" (e.g., the requirement to submit drug advertising at the time of first use to FDA on Form 2253). This statement is consistent with the agency's objective, as expressed by Commissioner Gottlieb, to facilitate value-based contracting. 
  • Near the end of the Payor Guidance, FDA asserts that there are potentially competing interests at stake between the need of payors and other similarly sophisticated audiences to obtain information, on the one hand, and the public health risk of manufacturers providing harmful and unsubstantiated information, on the other hand. The agency claims that the Payor Guidance appropriately balances and harmonizes these interests. Although FDA does not explicitly reference the First Amendment, the balancing language echoes language contained in the January 2017 First Amendment Memorandum described in a prior Ropes & Gray Alert and suggests that FDA may be attempting to ensure that the new guidance is both appropriate as a matter of policy and consistent with the Constitution.

Final Guidance on Communications Consistent with FDA-Required Labeling

  • While the draft version of the Consistent with the Labeling Guidance referred generally to product communications, the final applies only to labeling and advertising, i.e., the communications over which Congress granted FDA regulatory authority. A reasonable inference from this change is that  "scientific exchange" and other types of communications outside of FDA's statutory purview are not within the scope of the guidance. 
  • The Guidance retains the three-factor test from the draft guidance for determining whether a communication is consistent with the FDA-required labeling: 
    • Are the conditions of use described in the communication consistent with the product labeling? 
    • Does the communication alter the risk-benefit profile of the product in such a way that may result in increased harm to health? 
    • Does the product labeling enable the product to be used safely and effectively for the conditions of use described in the communication? 

    FDA provides a number of additional examples that manufacturers can rely on in applying the factors, including examples related to communications about compliance, adherence, and tolerability. 

  • FDA states that manufacturers of 510(k) and 510(k)-exempt devices should not rely on the three-factor test described above. Instead, for 510(k)-cleared devices, FDA directs firms to analyze communications in accordance with 21 C.F.R. § 807.81(a)(3) and FDA's guidance Deciding When to Submit a 510(k) for a Change to an Existing Device. For 510(k)-exempt devices, FDA directs firms to analyze communications in accordance with the limitations of exemptions in the device classification regulations. The Consistent with the Labeling Guidance notes, "FDA views communications that trigger a need for a 510(k) as inconsistent with FDA-required labeling. Conversely, FDA views communications that do not trigger the need for a 510(k) to be consistent with the FDA-required labeling, and does not intend to rely on such communications to establish a new or significantly modified intended use, or one that is different from the use for which the product is legally marketed." This FDA "clarification" may prove unhelpful to device manufacturers, particularly given the paucity of FDA guidance on the often-vexing question of when a specific use of a 510(k)-cleared device falls within the scope of a broader 510(k)-cleared indication.
  • The Consistent with the Labeling Guidance also provides additional context on the "scientifically appropriate and statistically sound" substantiation standard that product communications consistent with the labeling should meet. Specifically, FDA states that information based on "speculation or belief," as well as information "based on a poorly designed or conducted study or analysis," would not meet the substantiation standard, but it does not elaborate on data sources that may be inappropriate. In general, the Guidance explains that the standard is a flexible one, and it states that "FDA believes that a variety of types and studies and analyses can provide useful additional information about a medical product for its approved/cleared conditions of use" so long as "firms' product communications [do] not overstate the findings of or the conclusions that can be drawn from such studies or analyses, or fail to disclose their material limitations." 
  • Finally, the Consistent with the Labeling Guidance acknowledges, which the draft guidance did not, the apparent conflict between the "scientifically appropriate and statistically sound" standard it endorses and the regulatory requirement in 21 C.F.R. § 202.1(e)(6) that prescription drug advertising claims be supported by "substantial evidence." The Consistent with the Labeling Guidance now explicitly states that "evidence other than that which meets the new drug approval standard of 'substantial evidence' of effectiveness could be used to support certain representations or suggestions about a prescription drug in a [Consistent with FDA-required labeling ("CFL")] promotional communication." FDA goes on to state that it "does not intend to interpret its regulations . . . to the contrary," citing Section 202.1(e)(6). Because that formal regulation expressly requires substantial evidence for such claims, this statement in the Consistent with the Labeling Guidance seems to indicate that FDA intends, as a matter of enforcement discretion, not to enforce the regulatory standard in cases where product communications comply with the Consistent with the Labeling Guidance.


The two finalized guidance documents issued by FDA on June 12 contain extensive changes from the draft versions released in January 2017. Overall, the changes provide additional flexibility to medical product manufacturers to convey certain types of truthful, non-misleading product information, and provide more examples of information that FDA believes would or would not be appropriate to convey. Although these guidance documents address certain aspects of FDA regulation of manufacturer communications about unapproved uses of approved or cleared medical products, FDA has additional work to do in order to complete its comprehensive review of its policies in this area, as the MIWG and other industry groups have urged.

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
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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