pdf

FDA Issues Two Final Guidance Documents on Medical Product Communications

June 26, 2018

On June 12, the FDA issued two final guidance documents that describe the kinds of information drug and device manufacturers can disseminate: (1) “Medical Product Communications That Are Consistent With the FDA-Required Labeling;” and (2) “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities.”

The second guidance document provides clarification regarding the communication of health care economic information by manufacturers to payors concerning approved or cleared devices. Most importantly, the guidance allows manufacturers to provide certain types of information about unapproved uses of approved or cleared products. The FDA’s decision to allow communications on unapproved uses is significant. However, the types of information on unapproved uses that can be shared are circumscribed, and the audience for such communications is limited to payors, formulary committees, or other similar entities. The FDA has yet to provide updated guidance addressing manufacturer communications about unapproved products or unapproved uses of approved or cleared products to other important audiences, such as health care providers making individual prescribing decisions and consumers.

It is also worth noting that draft versions of both guidance documents were issued by the FDA in January 2017, just days before the end of the Obama administration. Thus, the issuance of these final guidance documents under current FDA Commissioner Scott Gottlieb, M.D., represents both an affirmation and expansion of the FDA’s policies allowing broader manufacturer communications and promotion in certain areas.

Background

On January 17, 2017, the FDA released a draft guidance document entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling” (“Consistent Communications” draft guidance). This draft guidance described how FDA evaluates manufacturer communications, including promotional materials, that present information not contained in FDA-required labeling, but that may be “considered consistent” with required labeling. The draft guidance explained that information that is consistent with the FDA-required labeling is limited to information about the approved or cleared uses of a product.

The draft guidance outlined the kinds of information not included in a drug or device’s FDA-required labeling that manufacturers could disseminate and the level of evidentiary support manufacturers should have before disseminating this kind of information. By following the recommendations provided by the FDA, manufacturers could communicate information not contained in the FDA-required labeling without the risk that it would be viewed by the FDA as “evidence of a new intended use,” i.e., triggering a potential FDA enforcement action.

In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA). Section 114 of FDAMA amended the statutory language in 21 U.S.C. 352(a) relating to the kind of health care economic information (HCEI) manufacturers may provide to payors and similar entities. However, the FDA never issued guidance interpreting this provision. The enactment of the 21st Century Cures Act in December 2016, made several small, but significant changes to Section 114 and spurred the FDA to issue long-awaited guidance on manufacturer communications with payors and dissemination of HCEI.

On January 18, 2017, the FDA released a draft guidance document entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities” (“Payor” draft guidance). This draft guidance described the kinds of HCEI relating to approved prescription drugs that, when shared with payors, formulary committees, or other similar entities, would not be deemed false or misleading, and which the FDA would not consider as evidence of a new intended use. The draft guidance also described the types of information (not limited to HCEI) regarding investigational drugs and devices (i.e., products that are totally unapproved or uncleared) that manufacturers could share with payors, formulary committees, or other similar entities. The draft guidance did not address the dissemination of information by manufacturers regarding unapproved uses of approved or cleared products.

Analysis of the Final Guidance Documents

There are no significant differences between the draft and final Consistent Communications guidance documents. Instead, the FDA provides a number of additional examples and expanded explanations to better understand terms in the final guidance. In addition, the final guidance clarifies: (1) that the guidance does not apply to compounded drugs because they do not have FDA-required labeling; (2) how the guidance applies to communications about devices cleared under 510(k)s and devices that are 510(k)-exempt; (3) that manufacturer communications that reflect changes to the labeling described in pending changes being effected (CBE) supplements would be considered consistent with FDA-required labeling; and (4) how FDA applies Factor 2 (whether the communication increases the potential for harm to health) and Factor 3 (whether the approved directions for use enable the product to be safely and effectively used under the conditions represented in the communication) of the three-factor test to determine whether a communication is considered consistent with the FDA-required labeling for the product.

Like the Consistent Communications final guidance document, the Payor final guidance document contains several new examples, expanded explanations, and clarifications when compared to the Payor draft guidance. However, the Payor final guidance also includes two significant changes from the Payor draft guidance.

First, the Payor final guidance contains a separate section regarding communication of HCEI to payors concerning approved or cleared devices. Although the title of the Payor draft guidance included drug and device manufacturers, the majority of the document concerned communication of HCEI by manufacturers to payors regarding approved drugs. Following issuance of the Payor draft guidance, several commenters suggested that the recommendations concerning HCEI about approved drugs could also be applied to devices. In the Payor final guidance, the FDA concludes that, although the language in 21 U.S.C. 352(a) applies only to drugs, the general requirement in 352(a) that labeling not be false or misleading applies to devices as well as to drugs. Thus, the FDA believes that the recommendations concerning approved drugs in the final guidance are generally applicable to device manufacturer communications of HCEI to payors as well. Therefore, if a device firm disseminates HCEI that complies with the recommendations regarding approved drugs, the FDA does not intend to consider such information false or misleading or as evidence of a new intended use.

Second, in response to industry comments on the Payor draft guidance, the FDA has expanded the section on communications by manufacturers regarding investigational drugs and devices to now include certain types of information concerning unapproved uses of approved or cleared products. When manufacturers provide communications to payors about unapproved uses, the FDA recommends that, in addition to the recommendations in the draft guidance, firms should provide a prominent statement disclosing the indication(s) for which the FDA has approved or cleared the product and a copy of the current FDA-required labeling. Thus, when manufacturers provide the types of information about unapproved uses described in the final guidance, and by following the other recommendations in the guidance, the FDA does not intend to object to such communications, nor to use such communications as evidence of a new intended use, nor to enforce any applicable post-marketing submission requirements for these materials.

Although the types of information about unapproved products and unapproved uses of approved or cleared products that the FDA will permit firms to share are limited (and essentially unchanged from the Payor draft guidance), the decision to allow communications on unapproved uses is significant and demonstrates the FDA’s willingness to allow broader manufacturer communications. However, readers are reminded that the audience for communications described in the Payor final guidance is limited to payors, formulary committees, or other similar entities. The FDA has yet to provide updated guidance addressing firm communications about unapproved products or unapproved uses of approved or cleared products to other important audiences, such as health care providers making individual prescribing decisions and consumers.


This memorandum is a summary for general information and discussion only and may be considered an advertisement for certain purposes. It is not a full analysis of the matters presented, may not be relied upon as legal advice, and does not purport to represent the views of our clients or the Firm. Steve Brody, an O’Melveny partner licensed to practice law in the District of Columbia, and Seth S. Ray, an O’Melveny senior counsel licensed to practice law in the District of Columbia, contributed to the content of this newsletter. The views expressed in this newsletter are the views of the authors except as otherwise noted.

© 2018 O’Melveny & Myers LLP. All Rights Reserved. Portions of this communication may contain attorney advertising. Prior results do not guarantee a similar outcome. Please direct all inquiries regarding New York's Rules of Professional Conduct to O’Melveny & Myers LLP, Times Square Tower, 7 Times Square, New York, NY, 10036, Phone:+1-212-326-2000.