Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Nov. 7 — 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 Fed. Reg. 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.
“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.”
Nonetheless, Kamp is 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.
Composed of media, health-care and other organizations, the Coalition for Healthcare Communication promotes the free exchange of scientific and medical information.
Kamp also said the FDA’s study proposal appears to be the agency’s attempt to make good on a promise Janet Woodcock, director of the FDA‘s Center for Drug Evaluation and Research, made to Rep. Billy Long (R-Mo.) in connection with H.R. 2479. Long introduced that bill in 2015 to update FDA’s regulation of online drug promotion, Kamp said.
Long’s bill would let pharmaceutical companies provide consumers with drug risk information by clicking on a separate link. The bill was included in early drafts of the 21st Century Cures legislation, legislation aimed at spurring development of new medical treatments and prevention therapies. But Long’s bill was subsequently dropped from the Cures bill and is now at the House Energy and Commerce Committee’s Subcommittee on Health.
Bloomberg BNA reached out to consumer groups including Public Citizen for comment on the FDA’s proposed studies Nov. 7 but no one was available to comment.
Comments on the studies are due Jan. 6, 2017.
To contact the reporter on this story: Dana A. Elfin in Washington at email@example.com
To contact the editor responsible for this story: Brian Broderick at firstname.lastname@example.org
The Federal Register notice is available at http://src.bna.com/jT8.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
Notify me when updates are available (No standing order will be created).
Put me on standing order
Notify me when new releases are available (no standing order will be created)