FDA May Be Thawing on One-Click Drug Risk Information Issue


Can consumers receive adequate information about the risks associated with prescription drugs promoted on social media by clicking on a separate link? The FDA plans to find out.

The Food and Drug Administration will study whether linking to prescription drug risk information can effectively convey the risks associated with prescription drugs marketed on character-space-limited outlets like Twitter and microblogs, it said in a Nov. 7 Federal Register notice (81 FR 78,163).

The issue is important to the drug industry because it wants to use the one-click approach to presenting drug risk information without facing government enforcement action. A one-click approach would allow regulated companies to present risk information for their products by clicking in from an underlying advertisement if the underlying ad is accurate and not misleading.

Pharmaceutical industry groups have long maintained that the FDA’s social media policies are too restrictive and fail to consider the character limits imposed on many of the platforms. Currently, the FDA requires fair balance in drug marketing—meaning that risk and benefit information have to appear together—even in online platforms with strict space limitations.

"It’s time for the FDA to enable robust communication in searches and on Twitter," John Kamp, executive director of the Coalition for Healthcare Communication in New York and consulting counsel to Wiley Rein LLP, told Bloomberg BNA Nov. 7. "This study could go far to advance that goal." The Coalition for Healthcare Communication promotes the free exchange of scientific and medical information.

Nonetheless, Kamp told me he’s concerned that the FDA's stated hypothesis for the studies "suggests that the status quo is needed to ensure that the risk information is fully understood."

"Given the plethora of bad information by others on the Internet, sponsor [drug company] communication should be encouraged, not discouraged," Kamp said.

Comments on the studies are due Jan. 6, 2017.

The Federal Register notice is at http://src.bna.com/jT8.

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