Feb. 28, 2011 — In yet another indication that industry and agencies should not expect major changes in social media marketing rules, Tom Abrams, the head of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), told participants at DIA’s annual marketing meeting in Washington, D.C., on Feb. 22 to “follow the regulations” while waiting for formal FDA guidance.

During an FDA enforcement update session at the DIA workshop, panel moderator Wayne Pines, president, regulatory services and health care, APCO Worldwide, posed a question about what advice Abrams would give companies regarding their Internet and social media activities. Abrams replied that both before and after any industry guidance is issued (likely by April 2011), companies simply should “follow existing regulations and policies.”

Elaborating, Abrams said, “There will be guidance on some specific matters, but there will be no new regulations or new standards. Look at our recent Warning Letters involving social media, such as Facebook. These Warning Letters cite existing rules and do not make new policy.”  

“Read this to mean that DDMAC is unlikely to create a major new standard for social media as it did in 1997 when it developed the ‘reasonable accommodation’ policies for broadcast advertising,” said Coalition for Healthcare Communication Director John Kamp. Many participants at the November 2009 FDA Internet and Social Media hearings urged the FDA to recognize that digital marketing was very different from traditional marketing and that the agency needed to adopt significant new policies.

The agency appears to be relying on current policy when conducting social media enforcement. A recent DDMAC Warning Letter on social media cited a company for generating misleading “shared content” using a Facebook Share “widget.” DDMAC stated in the letter that the company’s content made representations about the product but failed to communicate any risk information associated with use of the drug, implied superiority over other products and inadequately communicated the FDA-approved indication, thereby misbranding the drug. The basis for these alleged violations all were found in existing FDA regulations.

A Preview of Forthcoming Guidance

Abrams gave details on other DDMAC priorities as well, including updated guidance on the brief summary and comparative claims. He also discussed areas the agency is mandated to address under the FDA Amendments Act of 2007:  a preview program for certain direct-to-consumer (DTC) television ads and a report to Congress on a possible “drug facts” box (report issued April 2010), and a rule establishing standards for how the “major statement” of risk in consumer-directed prescription drug television and radio ads should be presented in a “clear, conspicuous, and neutral manner.”

The “clear, conspicuous and neutral” proposed rule, issued March 29, 2010, states that a major statement is clear, conspicuous and neutral if:

• Information is presented in language that is readily understandable by consumers;
• Audio information is understandable in terms of the volume, articulation and pacing used;
• Textual information is placed appropriately and is presented against a contracting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
• The advertisement does not include distracting representations (including statements, text, images or sounds or any combination thereof) that detract from the communication of the major statement.

Abrams emphasized a new fifth standard likely would require that major statements in television ads be included in both the audio and the visual parts of the presentation. Abrams said that this standard would be similar to one used for television ads by the Federal Trade Commission and would integrate research showing that a dual-mode presentation enhances consumer comprehension. Abrams had no comment regarding when the final rule on this matter would be issued.

“In his discussion of the DTC rulemaking, Abrams reiterated his commitment to the proposed standards,” Kamp. “In effect, he is indicating that these are the current standards being used by DDMAC and that companies should expect them to become fully integrated into the final guidance when issued.”

Warning Letters on the Rise

Abrams reported at the session that the number of Warning Letters issued by DDMAC in 2010 (52 Warning Letters) increased nearly 26 percent from 2009, and that he expects a similarly high number in 2011. As such, DDMAC encourages companies to voluntarily comply with FDA regulations in this area to avoid regulatory actions, preserve their image, provide good information to the public and prevent interruption of their promotional campaigns, he indicated.

This philosophy will continue as DDMAC is elevated to office status, which is likely to take place later this year. DDMAC is poised to enable an immediate transition to the new Office of Prescription Drug Promotion, which will consist of two divisions, one for healthcare professional promotional materials and one for consumer promotional materials.

Promotional vehicles cited in the 52 Warning Letters issued by DDMAC in 2010 included both traditional and evolving technology venues.

Other Social Media Perspectives

At a later DIA session on industry/agency perspectives on social media, moderated by the Coalition’s Kamp, Peter Pitts, president, Center for Medicine in the Public Interest, noted that promotional venues are irrelevant to compliance. If the content is noncompliant, he said, it is noncompliant regardless of the platform.

Pitts also pointed out that pharmaceutical social media critics may be confusing online advertising with social media and are reluctant to monitor social media sites for fear of discovering adverse events. He called the latter fear a misguided notion, stating that companies should be embracing opportunities to uncover adverse events in any forum.

Further, Pitts remarked that DDMAC should be addressing user-generated content and off-label conversations and should define property owners versus property users in its forthcoming guidance. He also would like to see DDMAC adequately address what the term “sponsored by” both means and implies in the social media context.

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