Pharma Companies Urge FDA To Alter Draft Social Media Rules

September 24, 2014 in News

Pharmaceutical groups have raised concerns that FDA’s draft social media guidance are not practical and could discourage pharmaceutical companies from interacting with consumers via social media, The Hill reports (Devaney, The Hill, 9/23).

Background on FDA’s Draft Guidance

In June, FDA issued draft guidance outlining how drugmakers and medical device makers should highlight the benefits and risks of their products via social media and how they should address and correct misinformation regarding their products posted by third parties.

The draft guidance would require drug and medical device manufacturers to disclose the benefits and potential risks of their products when posting about the items on social media, even if the social media platform only offers limited character space.

For example, the manufacturer would have to specify whether a hypothetical memory loss drug was for “mild to moderate memory loss,” rather than just for “memory loss.” The draft guidance notes that there might be limitations in character space on some social media platforms, which “may not enable meaningful presentations of both benefit and risk,” especially for products with “complex indications or extensive serious risks.”

The draft guidance would permit simple “reminder” promotions, which feature only the name of the product.

The draft guidance also would permit manufacturers to correct product misinformation posted by third parties or in chat rooms. In such instances, companies would not be required to detail all of a product’s risks and benefits as long as they provide corrections that are clear, accurate and not misleading.

In addition, the guidance would allow companies to correct misinformation posted on online forums or submit a correction to an individual blogger or website. Under the guidance, companies would not be accountable for misinformation that a blogger or website creator failed to correct.

However, the guidance would not provide the same flexibility for corrections when the information is posted by a company employee or an affiliate firm. It also would not allow companies to monitor discussions on its own website or to edit comments that portray a product negatively while adding positive comments (iHealthBeat, 6/18).

The comment period on the draft guidance ended last week.

Pharmaceutical Research and Manufacturers of America Comments

The Pharmaceutical Research and Manufacturers of America in a comment to FDA said that the draft guidance would have a “chilling” effect on manufactures’ ability to use social media to convey medical information to consumers about their products (The Hill, 9/23).

PhRMA identified two fundamental concerns with the draft guidance:

  • The assumption that biopharmaceutical developers can be held responsible for content written by third-parties and on third-party websites if they have influence on the third party; and
  • The failure to provide guidance about what kinds of statements correcting misinformation on social media qualify as labeling or advertising.

The group recommended that the final guidance:

  • Confirm FDA’s commitment to protecting online scientific exchange via social media;
  • Detail how companies could correct false or misleading third-party information regarding a products’ off-label uses; and
  • Permit companies to link to any FDA-compliant site when correcting misinformation (PhRMA comments, 9/16).

Biotechnology Industry Organization Comments

Meanwhile, the Biotechnology Industry Organization in a comment criticized FDA for adopting a “broader interpretation of the concept of ‘influence or control,’” with little clarity.

The group also called for FDA to provide additional flexibility to manufacturers to correct misinformation online “given the realities of the platforms on which these conversations are already taking place.” BIO said that denying such flexibility would result in a “chilling effect on manufacturer participation” in online conversations.

BIO emphasized that manufacturers should be “entitled to broad protection” under the First Amendment to participate “in the scientific and medical dialogue … even if the content or distribution method may be inconsistent with this draft guidance” (BIO comment, 9/16).

Medical Information Working Group Comments

Similarly, the Medical Information Working Group in a comment said the requirement for manufacturers to be responsible for information about their products posted by third parties would be “impermissibly broad” and beyond FDA’s statutory authority (MIWG comment, 9/16).

MIWG added that such a requirement is “impracticable in the Internet and social media context, where interactive communications are the norm and [user generated content] is unpredictable” (The Hill, 9/23).

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