Life Science Compliance Update

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September 26, 2013

FDA and Social Media Do’s and Don’ts Based on Warning Letters, Waiting for July 2014 Guidance?

The Food and Drug Law Institute (FDLI) recently held its annual Advertising & Promotion Conference, which included in-depth presentations on the use of social media. John Manthei, Partner at Latham & Watkins LLP, focused his presentation on three recent issues and enforcement trends: 1) social media; 2) web-based advertising; and 3) securities disclosures.

Tom Abrams Director, Office of Prescription Drug Promotion (OPDP) at the FDA at a separate session shared that the long awaited social media guidance is his offices highest priority. That it is the intent of the agency to meeting the July 2014, goal date set by congress for completion of those guidelines. He also discussed that this guidance is working its way through several of their centers and during each centers review they have received significant impact.

With respect to social media, John gave a brief overview of the various social media (e.g., Facebook, LinkeIn) and also explained types of digital advertising and promotion. He distinguished between

  • Owned/sponsored media, which are company and product websites and social media platforms or sponsored "disease awareness" sites;
  • Paid media, such as web-based advertising
  • Earned media, such as "online word-of-mouth" or organic search results; and
  • Hosted media, such as patient and physician online communities

While social media has unique capabilities such as "immediacy, personalization, and accessibility," Manthei also noted its drawbacks. For example, control and/or ownership of social media is an extremely important issue, particularly with respect to FDA, FTC and OIG enforcement. Reliability of information online is also an important drawback to consider.

Consequently, Manthei noted that currently there is no final guidance on the use of social media and advertising and promotion; however, FDASIA requires that FDA issue guidance on its policy toward Internet and social media promotion no later than July 9, 2014. FDA has issued Warning letters on social media, but has not taken any further steps other than several meetings. Manthei noted that the Warning Letters have centered on off-label statements and failure to satisfy fair-balance advertising requirements. Nevertheless, FDA's stance with respect to social media is that the agency's advertising and promotion rules apply "regardless of the medium used."

After noting a few examples of FDA warning letters, Manthei offered several compliance tips for social media. First, establish a clear corporate social media policy and provide adequate training to employees. Ensure company posts are accurate, current, and contain adequate disclosures and ensure company posts do not discuss off-label or investigational issues.

Second, if a company plans to allow third-party content on company-hosted media, the company must have full control over that content to ensure continued compliance. Companies should Post a clear "Terms of Use" to alert users that content will be reviewed and may be deleted. Companies should also onitor content to correct inaccurate information and follow-up on off-label questions and potential adverse events.

For web-based advertising, Manthei recommended that companies ensure that internal advertisement and promotional labeling review programs are attuned to developing issues in the new media space. Companies should seek external review of their program for further guidance on advertising compliance. Internal review should ensure that web-based advertising, regardless of format, is:

  • accurate, current, and not misleading;
  • fairly balanced; and
  • free of any statements on off-label or investigational issues.

Finally, Manthei discussed Securities disclosures, noting how the Securities and Exchange Commission (SEC), similar to FDA, is responsible for regulating firms' public statements to ensure they are truthful and non-misleading.

The SEC's regulation requires that when an issuer discloses material nonpublic information to certain individuals or entities—generally, securities market professionals, such as stock analysts, or holders of the issuer's securities who may trade on the basis of the information—the issuer must make public disclosure of that information. The rule aims to promote the full and fair disclosure. Manthei noted, however, that while SEC has jurisdiction over a corporate statement, that does not preclude action by FDA.

In discussing this issue, Manthei gave the example of the ImClone case. In 2001, FDA rejected ImClone Systems' BLA for its cancer drug Erbitux after initially granting fast-track and accelerated approval status. Before the rejection, ImClone had issued increasingly positive securities statements which caused its stock price to rise substantially. The rejection caused the stock to plummet and investors claimed they were mislead.

The case lead to a congressional inquiry, an insider-trading investigation, and civil lawsuits. Many questioned how the FDA and SEC could have prevented misleading statements to the investment community. Accordingly, Manthei offered several rules of thumb for press releases and corporate statements. He noted that while FDA is unlikely to object to a disclosure that is required under the securities laws "embellishment and gratuitous information may attract FDA's attention"

This is particularly true if "the statements focus on positive information about a product while omitting negative and/or risk-related information." He also reminded the audience that the FDA maintains a centralized procedure for referring to the SEC statements by FDA-regulated firms that may be false or misleading.

In addition, he noted that the SEC may scrutinize disclosures about FDA-related events to prevent stock price manipulation (e.g., if the filing of an NDA is material, so is its rejection). Manthei then gave two enforcement examples. First, FDA sent a Warning Letter to Medtronic in 2010, citing a September 2006 press release located on the company's website that announced the availability of a new device in the United States when the applicable 510(k) for the product was not cleared by FDA until March 2007. In addition, the press release made several claims for which the company had not obtained marketing clearance or approval.

Second, the SEC filed an enforcement action in 2012 against BioChemics, Inc., a biopharmaceutical company, along with its CEO, for making false statements to investors about collaborations with major pharmaceutical companies and the status and results of drug trials of the company's main product. The case remains ongoing. SEC is seeking injunctive relief, disgorgement, and civil penalties, as well as securities-related debarment orders against the individuals involved.

Accordingly, Manthei offered several compliance tips, such as implementing internal review procedures to ensure public statements are accurate, complete, and not misleading pursuant to both SEC and FDA requirements. Review procedures should ensure consistency between statements to the investment community and to FDA. Additionally, he noted that companies should be "complete and accurate" when drafting public statements subject to SEC and FDA scrutiny. Companies should not omit or mischaracterize relevant communications from FDA (e.g., clinical holds, safety concerns) and they should not "get out in front of FDA by implying or stating that a developmental product is safe and effective for an indication that is still investigational."

In a second panel, dedicated to social media, several experts discussed how drug and device companies are currently using social media and several critical questions FDA has left unanswered. The panel also went through interactive examples of Facebook and Twitter pages, discussing the potential legal and regulatory implications of these social media sites.

The panel noted that 82% of drug and device companies actively participate in at lease one form of social media activity, but their experience is "widely diverse." Historically, most social media activity focused on the company and industry information; disease awareness; and patient support and use. New trends companies are seeking include physician targeting, generating competitive intelligence, and facilitating internal company communication. The panel, noted however, that FDA must first answer the following questions:

  1. For what online communications are manufacturers accountable?
  2. How can manufacturers fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion,
    1. Particularly when using tools that are associated with space limitations and tools that allow for realtime communications (e.g., microblogs, mobile technology)?
  3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
    1. Permitted
    2. Required

4. When is the use of links appropriate?

5. What are the implications for monitoring and reporting adverse event information about their products?

The panel noted that FDA's enforcement trends have been affirmative acts on social media regulated as labeling, including over "a dozen Warning Letters" concerning companies Facebook page. One example was in December 2012, for "Liking" off-label content.

Additionally, themes from warning letters include a focus on "testimonial and case studies" and whether patients are typical or outliers. Other factors FDA is looking at in social media include:

  • Off-label promotion
  • Substantiation;
  • Balanced, integrated presentations of risk
  • Comparative claims; and
  • Indifference to the challenges of space constraints (e.g., Twitter)

In particular, the panel noted that FDA is focusing on videos, which are often treated as free standing ads that are separately viewable and shareable. This means that the video must have:

  • Risk information within the video;
  • Fair balance within the video;
  • The video cannot rely on outside content for explanation; and
  • Testimonials increase requirements

In looking at several companies use of Facebook, the panel then discussed the business benefit, if any, of having a Facebook page. The panelists discussed with a clear "Terms of Use and Posting Guidelines" for such pages provide any comfort for engaging consumers. The panel also discussed what kind of "back-end" process companies would need to support 'real-time' posting and whether companies would manage commenting on such pages.

The panel also discussed the reporting of adverse events through social media and whether companies have a duty to monitor and collect such information.

Additionally, the panel discussed the use of social media to recruit patients for clinical trials and studies, directly or through a third party. This discussion focused on whether an Ethics Committee must approve the advertising used for such recruitment and what additional information is required. The panel noted several strengths with using this recruitment method, such as finding qualified patients directly or through caretakers and advocacy groups as well as monitoring patient behavior for those who enroll in the trial. However, this area is still uncertain and lacks FDA guidance the panel noted.

It is hopeful that the FDA may provide guidance in the future, but for now companies are forced to make educated guesses based on others warnings.

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