FDA Issues Draft Guidance Addressing Postmarket Submission Requirements for Internet-based Promotional Materials
On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. The draft guidance, which describes how firms may fulfill the postmarket requirement to submit promotional statements when such statements are disseminated or published via internet-based media, represents the Agency’s first step towards fulfilling the Food and Drug Administration Safety and Innovation Act’s requirement that the Agency provide, by July 9, 2014, formal guidance on the manner in which it intends to regulate the publication and dissemination of promotional materials on the internet.
On January 14, 2014, the U.S. Food and Drug Administration (FDA or Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. This On the Subject provides an overview of the draft guidance and its implications for regulated firms.
The FDA has long acknowledged industry’s need for comprehensive guidance on internet and social media promotion of regulated products. Indeed, in November 2009, the Agency held a public meeting and established an electronic docket that afforded interested entities the opportunity to provide comments on this topic, and in December 2011, it issued a related draft guidance that included recommendations for responding to electronically submitted, unsolicited requests for off-label information (summary here).
The Agency has not, however, issued detailed guidance on most topics related to internet promotion of FDA-regulated products. For example, the Federal Food, Drug and Cosmetic Act (FDCA) requires the holder of a marketing approval for a prescription drug or biologic to submit all promotional labeling and advertisements to the FDA at the time of initial dissemination (for labeling) or at the time of initial publication (for advertisements). Similarly, federal regulations require the holder of a marketing approval for an animal drug to submit one set of specimens of any mailing pieces and other labeling at the time of initial dissemination and one set of specimens for any advertisement at the time of initial publication or broadcast. Increased development and use of social media, however, has increased the total number of communications that may be viewed as promotional and has enabled many such communications to be published in real time. As such, it may be difficult—if not impossible—for firms to submit all promotional labeling and advertising pieces at the time of initial dissemination or publication.
Definition of the term “interactive promotional media”
Factors the Agency considers in determining whether a postmarketing submission is required for interactive promotional media
Recommendations for submitting interactive promotional media materials to the Agency
What is interactive promotional media?
The draft guidance applies to promotional statements made via “interactive promotional media,” which the FDA describes as including “modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts) that firms use to promote their drugs.” For example, the draft guidance applies to promotional statements made via Twitter, Facebook, websites and message boards.
What factors will the FDA consider in determining whether a firm is required to submit promotional statement(s) made via interactive promotional media?
The Agency proposes to consider the following factors when determining whether it expects a firm to submit postmarket promotional statements:
A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced or operated by or on behalf of the firm. The Agency will consider whether the firm, or anyone acting on behalf of the firm, influences or controls the promotional activity or communication in whole or in part. A firm is responsible for submitting promotional materials if it exerts influence over a site “in any particular”—e.g., collaborates on or has editorial, preview or review privileges over the content provided—even if its influence is limited in scope.
Under certain circumstances, a firm is responsible for promotion on third-party sites. A firm is responsible for submitting promotional materials on a third-party site if the firm has any control or influence over the third-party site, even if that influence is limited in scope. If a firm provides only financial support (e.g., through an unrestricted educational grant) and has no other control or influence over the site, however, the firm has no obligation to submit the content to FDA. Moreover, if a firm provides promotional material to be used on a third-party site but does not direct the placement of the promotional material or have any control or influence over the site, the firm needs only to submit the promotional content that it contributed, not the content of the site as a whole.
A firm is responsible for the content produced by an employee or agent who is acting on behalf of the firm to promote the firm’s product. A firm is responsible for submitting user-generated promotional content (e.g., comments on a message board) and communications of its employees or anyone acting on its behalf. FDA recommends that a firm be transparent in disclosing its involvement on a site by clearly identifying the user-generated content and communications of its employees or entities acting on its behalf. Importantly, a firm is generally not responsible, however, for content that is truly independent of the firm (i.e., not produced by or on behalf of the firm and not prompted by the firm in any particular). As such, FDA will not ordinarily view user-generated content on firm-owned or -controlled venues, such as blogs, message boards and chat rooms, as promotional content on behalf of the firm, as long as the poster has no affiliation with the firm and the firm had no influence on the user-generated content.
How does the Agency recommend that a firm submit promotional statements made in interactive promotional media?
The Agency intends to exercise enforcement discretion with respect to the postmarket submission requirement if the firm submits interactive promotional media, as described below:
At the time of initial display, a firm should submit in its entirety all sites for which it is responsible [on Form FDA 2253 (for human drugs and biologics) or 2301 (for animal drugs)]. The firm should submit the comprehensive static product website, with the addition of the interactive or real-time components, and include annotations to describe the parts that are interactive and allow for real-time communications. Any subsequent changes should be annotated and resubmitted to the Agency at the time of initial display. The firm should also provide a cross-reference by noting the submission date of the most recent version of the site. After the initial submission or resubmission, however, if the site is publically accessible without restrictions, such as password or subscription (nonrestricted), and remains unchanged other than displaying real-time information, the FDA does not intend to object if the firm submits an updated listing of the site that does not include screenshots or other visual representations of the actual interactive or real-time communication.
For third-party sites on which a firm’s participation is limited to active or real-time communications, a firm should submit the homepage of the third-party site, along with the interactive page within the third-party site and the firm’s first communication at the time of initial display. The firm may include any annotations that describe its communications within the third-party site. After the initial submission, if the firm remains an active participant on the third-party site and that site is nonrestricted, FDA does not intend to object if the firm submits an updated listing of the website that does not include screenshots or other visual representations of the actual interactive or real-time communication.
Once every month, a firm should submit an updated listing of all nonrestricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots or other visual representations of the actual interactive or real-time communications with the monthly updates. Multiple sites and the corresponding documents can be submitted with a single form. Firms should include a separate document for each site, however, that includes the site name, URL and date range, as well as a cross-reference to the date of the most recent submission of the site.
If a site has restricted access and, as such, FDA may not have access to the site, a firm should submit all content related to the discussion (e.g., all user-generated content about the topic), which may or may not include independent user-generated content, to adequately provide context to facilitate the review. Screenshots or other visual representations of the actual site, including the interactive or real-time communications, should be submitted monthly.
When submitting the site, FDA recommends that a firm take formatting factors (e.g., appearance, layout, visual impression) into consideration to enable the Agency to view the communications as a whole.
Stakeholders interested in commenting on the draft guidance should submit comments to the FDA by April 14, 2014.
The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the FDA to issue comprehensive guidance describing its policy on the promotion of regulated medical products on the internet (including social media) by July 9, 2014. This draft guidance represents the Agency’s first step towards meeting this broader requirement.
In general, the draft guidance takes a position consistent with the extent to which the Agency currently regulates promotional material—firms are responsible for the content and submission of promotional items that they own, control, create, influence or operate (either by themselves or through an agent), as well as items created by employees or agents. The Agency’s clear statement that firms are not responsible for user-generated content that is truly independent is significant and should be welcomed by companies desiring to expand their presence in social media.
The submission(s) required to fall within enforcement discretion appear to strike a reasonable balance between the Agency’s mandate to review promotional materials and the excessive burden on the Agency and on industry if the Agency reviewed all promotional materials disseminated through interactive promotional media. Although the initial submission requirements do not distinguish between open-access and restricted websites, the Agency has proposed to impose less burdensome subsequent submission requirements for open-access websites, i.e., websites that the Agency can access on its own. Accordingly, to reduce the burden associated with meeting the submission requirement, firms may choose to limit promotional statements made in a password-protected (non-open-access) environment.
Notwithstanding the above, the draft guidance leaves a number of critical issues unaddressed. For example:
Content. What type of content is appropriate for publication or dissemination via interactive promotional media? Under what circumstances should a firm provide a copy of product labeling with posted information? Is a link to product labeling sufficient, or should a copy of the labeling be attached or relevant information from labeling be spelled out in the post itself? When (and what type) of critical information (e.g., full indication statements (with important limitations), black box warnings, contraindications and adverse events) should be included?
Responding to Inquiries Regarding off-label Use. How should a firm respond to externally originated inquiries regarding off-label use? If the question is posed to the general public, may the firm respond to the general public, or should the firm respond via private message to the specific external user that posed the question? Is there an obligation to remove such questions from the website? If so, within what time frame?
Factors for Determining When an Employee or Agent Is Acting on Behalf of the Company. How will the Agency make this determination—should it consider the manner in which the employee or agency represents himself (or herself) to readers of the post? The content of the message? Policies and procedures established by manufacturers? The date and/or time at which the information was posted? How will the FDA treat comments of a third party (e.g., a blogger) that goes beyond the scope of the agency agreement?
Microblogs. Given space limitations, should microblogs be treated differently than other internet-based promotional media?
Interested parties should monitor communications from the FDA during the next few months to stay apprised of the Agency’s progress in providing its broader guidance on social media and internet promotion. As guidance documents are posted by the Agency, firms may wish to consider updating applicable policies and procedures to facilitate compliance. In the meantime, it remains to be seen whether, based on this draft guidance, regulated firms will increase their use of interactive media given the general reluctance (until now), in view of the FDA’s enforcement activities in recent years relating to internet- based communications, including, for example, the use of Facebook.
If you have any questions about the information contained in this On the Subject or the guidance in general, please feel free to contact one of the authors or your regular McDermott attorney.