In a letter posted last week, FDA said pharmaceutical companies that use the "Facebook Share" application to promote their products must include information that complies with agency regulations, CongressDaily's "Tech Daily Dose" reports.
The application allows Facebook users to share online content through a link that features a brief description and thumbnail image of the item.
FDA Action
FDA's clarification was prompted by what the agency described as "misleading" information included in the description of Novartis' leukemia drug Tasigna.
The description "makes representations about the efficacy of Tasigna, but fails to communicate any risk information associated with the use of this drug," FDA wrote in its letter to Novartis (Krigman, "Tech Daily Dose," CongressDaily, 8/9).
FDA said that the description of the drug also:
- Implies superiority over other products; and
- Misleadingly describes the drug as a "next-generation" treatment.
In addition, Novartis did not submit the Facebook materials to FDA 30 days prior to initial publication, as required under federal rules (Loftus, Dow Jones/Wall Street Journal, 8/5).
Novartis Response
In response to the FDA letter, Novartis removed the Facebook Share application.
A Novartis spokesperson said the company "will continue to have active discussions with the FDA to understand fully all of the concerns," adding, "We will also assess all of our Web assets and materials based on these concerns" ("Tech Daily Dose," CongressDaily, 8/9).
Further Concerns
Jeffrey Chester -- executive director of the Center for Digital Democracy -- said FDA's letter highlights concerns about pharmaceutical advertising on Facebook and other websites.
He added that Facebook should be responsible for developing safeguards for pharmaceutical marketing and advertising for other health products in order to protect consumers (Gross, Bloomberg Businessweek, 8/6).