FDA Issues Guidance on Reporting Requirements for Web-based Promotion of Drugs and Biologics

REGULATORY & MARKETPLACE

8 INTERNATIONAL PHARMACEUTICAL INDUSTRY Summer 2014 Volume 6 Issue 2

The FDA has finally given some guidance on what drug companies must do to comply with federal reporting requirements when marketing their products through social media websites and other interactive media. This alert summarises this new and long-awaited guidance from the FDA.

Background on ‘Post-marketing Submissions’ to the FDADrug companies must submit to the FDA copies of all documents used to promote pharmaceuticals and biologics in the United States. This includes print, television advertisements, and online advertisements. The FDA reviews these “post-marketing submissions” (so called because they typically are submitted to the FDA immediately after they have been published) to ensure that they comply with regulations requiring elements such as disclosure of known risks and citations to evidence supporting all claims made in the promotional materials.

With the emergence of social media sites – where a drug company may have limited control over how its products are discussed and how its marketing materials are disseminated – the reporting obligations have been unclear. Must a company provide the FDA with a copy of every tweet or Facebook post about its product?

In July 2012, after many years of silence from the FDA on the issue, Congress gave the agency a two-year deadline to issue some guidance. On January 13, 2014, the FDA released “Guidance for Industry: Fulfilling Regulatory Requirements for Post-marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” The document notes that it is a draft only but notes that the document “when finalized, will represent the [FDA’s] current thinking on this topic.”

New Guidance from the FDAThe document lists three broad scenarios in which a company (or “firm”) should submit its online promotional materials

to the FDA. The following is a summary only. The complete guidance is available here.

Scenario 1: Promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.

This category of site includes micro-blog sites such as Twitter, social networking sites such as Facebook, and “other sites that are under the control or influence of the firm.” To determine whether a company has control or influence, the FDA looks to whether the company – or anyone acting on its behalf – is “influencing or controlling the promotional activity of communication in whole or in part.”

If a drug company “has editorial, preview, or review privilege” over the content of

the promotional materials provided to a website, then the company is responsible for that content and should submit such materials to the FDA. This would seem to include any promotional materials the company disseminates through its official Facebook, LinkedIn, or Twitter account.

Scenario 2: Promotional materials on third-party sites.

A company is responsible for promotion on third-party sites if the company has “any control or influence on the third-party site, even if that influence is limited in scope.” As with the sites described in scenario 1 above, if the drug company collaborates or has editorial, preview, or review privileges, then it is responsible for its promotion on the site and should submit the promotional documents to the FDA.

If a company provides only financial support (for example, through an unrestricted grant) but has no other control or influence on the site, then the firm is not responsible for information on the third-party site. Also, if a firm is merely providing promotional materials to a third-party site but does not direct the placement of those materials within the site – and has no other control or influence on that site – the firm is only responsible for the content it places there and only must submit to the FDA the material that was submitted to the site.

Scenario 3: A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.

A drug company’s reporting obligations to the FDA extend to promotional activities that are conducted on the company’s behalf. For example, if an employee or agent, acting on the company’s behalf, comments on a third-party site about the firm’s product, the firm is responsible for the content its employee or agent provides. This obligation extends to content on a blogger’s site if the blogger is acting on behalf of the company, and to user-generated content (UGC) such as comments in discussion forums if those comments are made on behalf of the company.

The FDA’s guidance offers two examples of this scenario. First, if a sales rep acting on behalf of the company posts comments about the innovative release mechanism of the company’s product on an independent third-party site, the company is responsible for submitting

the comments to the FDA. Second, if a blogger paid by the company maintains a blog about the company’s product, the company likewise is responsible.

New Recommendations for Submitting Interactive Promotional MediaThe new guidelines acknowledge that some websites include promotional content that changes in real time, and it is impractical for companies to submit copies of each instance of the constantly evolving webpage. For these situations, the FDA offers the following guidance.

Submission of Websites that Have Interactive Parts that Update in Real Time

At the time that a promotional website is initially displayed, the company should submit the entire website using Form FDA 2253 or Form FDA 2301 (the “Forms”). The company should include annotations to describe the parts that are interactive and allow for real-time communication. Any subsequent changes to the site (other than changes in the real-time information) should be annotated and resubmitted to the FDA.

Submission of Third-Party Sites in which a Company’s Participation is Limited to Interactive or Real-Time Content

The company should submit the home page of the third-party site, along with the interactive page within the third-party site and the company’s first communications therein, using the Forms. The company may include annotations that describe its communications within the third-party site.

Monthly Disclosure of Websites Once every month, a company should submit to the FDA an updated listing of all non-restricted (i.e., non-password protected) sites for which it is responsible, or in which it remains an active participant, and that include interactive real-time communications. For these monthly submissions, the party need not include in the Forms screenshots of the actual interactive or real-time communications. Companies should include a separate document for each site 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. The company should advise the FDA on the first day that the company stops being active on the site.

Additional Requirements for ‘Restricted’ Websites

If a site has restricted access such that the FDA may not have access to the site, the company should submit all content related to the discussion (including all UGC about the topic) to provide context for the review. Screenshots or other visual representations of the actual site should be submitted monthly using the Forms.

ConclusionThe new guidelines leave some uncertainty. For example, the degree of influence or control that a company exerts over a website that will trigger a company’s reporting obligations will be a case-by-case determination that the company itself must make. Another gray area is when an employee acts “on behalf of” the company such that the employee’s online comments must be submitted to the FDA. Despite this lingering uncertainty, the new guidance is a welcome glimpse into the FDA’s current thinking on what a company must do to comply with federal post-marketing submission requirements.

Nick Nelson is an associate in the Business Litigation Practice Group in the Dallas office of Haynes and Boone, LLP. His practice focuses on trade secret, trademark,

and copyright litigation and all facets of media law.Email: nick.nelson@haynesboone.com.

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