Healthy Skepticism Library item: 17876

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Richwine L
US FDA says Roche, Sanofi promotions misleading
Reuters 2010 Apr 23
http://www.reuters.com/article/idUSN2318682620100423

Abstract:

• Agency objects to cancer, HIV, bowel drug promotions

• Complaints cite consumer video, sales rep statements

Full text:

Roche Holding AG (ROG.VX), Sanofi-Aventis SA (SASY.PA) and Adolor Corp (ADLR.O) made misleading claims about cancer, HIV and bowel drugs, U.S. regulators said in letters released on Friday.

The Food and Drug Administration objected to a video for consumers from Roche unit Genentech about cancer drug Herceptin. The video “minimizes the serious risks associated with the use of Herceptin and presents misleading claims regarding the benefits,” the FDA said in March 26 letter to the company.

In a separate April 6 letter, the FDA said three Roche sales materials made misleading claims about HIV drug Invirase.

Roche spokesman Terry Hurley said the company had removed the video from the Herceptin website and stopped using the Invirase promotions that drew the FDA complaints.

“We take all matters related to promotion of safety and efficacy of our medicines seriously,” Hurley said.

“We will work to ensure our promotional materials are in compliance based on this guidance from the FDA.”

The FDA also said an Adolor sales representative had minimized the risks of bowel drug Entereg and overstated effectiveness in comments made at a December 2009 pharmacists’ meeting. The letter to Adolor was dated April 21.

With Sanofi, the FDA said in an April 20 letter that one of the company’s promotions made unsupported claims about prostate cancer drug Eligard.

Sanofi spokeswoman Emmy Tsui said the company was evaluating the letter and “will determine appropriate next steps.”

An Adolor spokeswoman did not immediately respond to a request for comment.