Oct. 6, 2104 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) recently reopened the comment period for its two social media draft guidances, all three major industry trade associations – the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Advanced Medical Technology Association (AdvaMed) – already had submitted their comments, which call out significant flaws in the agency’s attempts to provide more clarity on how it will regulate use of social media.

OPDP’s two draft guidance documents, which cover correcting independent third-party misinformation online and presenting risk and benefit information in social media platforms with character space limitations, were issued in June, with comments due by Sept. 16; on Sept. 26, OPDP announced that it would reopen the comment period for 30 days to allow for additional comment.

“As the FDA collects even more comments in this area, it is clear that there is a long road ahead to reaching consensus,” said Coalition for Healthcare Communication Executive Director John Kamp. “Industry must continue to make OPDP aware of the ‘real-world’ use of social media and of their First Amendment right to speak truthfully about their products in any forum, including a 140-word Tweet.”

Highlights from the PhRMA, BIO and AdvaMed comments are listed below.

Correcting Misinformation Online

In general, the trade associations reminded the FDA that its policies need to recognize the First Amendment protections afforded to truthful speech about their products.

• “FDA should avoid chilling manufacturers’ responsible communication of medical information about their products and the correction of third-party misinformation concerning these products. Moreover, any guidance document or other policy statement issued by FDA should be consistent with the principles and limitations of the Federal Food, Drug and Cosmetic Act (FDCA) and the First Amendment.” (PhRMA)
• “The provision by a manufacturer of truthful and not misleading information about a manufacturer’s products has constitutional protection under the First Amendment.” (BIO)

They also objected to the FDA’s adoption of the term “influence” as it relates to the control of online communications.

• “PhRMA recommends that FDA will provide an adequate safe harbor for companies to correct misinformation about medicines online by expanding the scope of the Draft Guidance through elimination of the ‘influenced’ prong of FDA’s definition of applicable communication. … The term ‘influenced,’ when used to limit the proposed safe harbor for the correction of misinformation, is both vague and overbroad.” (PhRMA)
• “While the manufacturer controls the original message, they cannot control the manipulation of content independent of the company.” (AdvaMed)
• “FDA has provided little clarity to address the ambiguous ‘influence or control’ concepts it published in the January Draft Guidance, and has not explained why such a broad interpretation remains appropriate. … There is no regulatory basis to hold a firm responsible for statements that are not made by or on behalf of the firm.” (BIO)
• “We note that unauthorized third-party modifications of companies’ materials are outside companies’ control and constitute third-party controlled content.” (AdvaMed)
• “BIO believes that within the bounds of a clearly defined monitoring and moderation plan, the firm should not be viewed as influencing the user-generated content that is independent of the firm, when removing or responding to posts that violate the rules of engagement.” (BIO)
• “If a manufacturer ‘collaborates’ with a third-party on any aspect of a third-party site, the manufacturer will become potentially responsible for all speech by that third-party. Manufacturers could then be subject to burdensome regulatory requirements and the threat of criminal penalties for speech that they do not even control. FDA should therefore remove the ‘influence’ test from the Draft Guidance.” (PhRMA)
• “The ‘influence’ test is not supported by the Communications Decency Act, which expressly prohibits holding web site hosts responsible for third-party speech.” (PhRMA)

Social Media Platforms with Character Space Limitations

The trade groups also commented on the agency’s very limited parameters for using social media venues with character space limitations.

• “We are concerned that FDA is proposing unnecessarily strict standards in character limited space than [it applies] in non-character limiting space. … These interpretations are not found anywhere in the laws or regulations cited.” (BIO)
• “FDA should consider whether the need for fair balance might be met with a combination of links and appropriate introductory language. … FDA [also] might consider a risk-based system for providing risk information in social media platforms with character space limitations.” (AdvaMed)
• “Because these restrictions apply only to companies sharing information about their medicines, the restrictions constitute significant content- and speaker-based burdens on speech subject to heightened scrutiny.” (PhRMA)

Further, they assert that OPDP should not rule out links to additional risk-benefit information.

• “The Draft Guidance should also provide for alternative approaches which allow for the provision of detailed safety information through common social media applications such as links with directional statements to safety information.” (BIO)
• “Use of a short link … and removal of trademark/registration symbols should be permitted to allow further space in these space-limited platforms apart from link to risk-benefit information.” (AdvaMed)
• “On some platforms, such as Twitter, links are generally automatically shortened … we ask FDA to acknowledge that use of unshortened URLs may not be under a company’s control and use of platforms that automatically shorten URLs would not be in violation of the guidance.” (BIO)

PhRMA takes the position it its comment that the FDA’s draft guidance “is inconsistent with the agency’s own responsible communications about medicines using Internet and social media platforms with character space limitations.”

• “It cannot be truthful and non-misleading for FDA to use character-space limited platforms in one way, but misleading for biopharmaceutical companies to do the same.” (PhRMA)
• “As a matter of First Amendment law and logic, it cannot be truthful for FDA to use Twitter in this way but misleading for product sponsors to do the same.” (PhRMA)