Healthy Skepticism Library item: 17868
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
US warns Roche, Shire on misleading drug promotions
Reuters 2010 May 5
http://www.reuters.com/article/idUSN0520882820100505
Abstract:
- Genentech cited for Rituxan, Shire for bowel drugs
- Shire says stopped using materials
- Genentech says working to remove materials
Full text:
U.S. regulators have warned Roche Holding AG unit Genentech and Shire Plc about misleading promotions for cancer and bowel drugs, letters released on Wednesday said.
In an April 29 letter, the Food and Drug Administration said promotional materials from Genentech made unsupported efficacy claims for cancer drug Rituxan and left out important risk information.
“The overall effect of these misleading presentations undermines the communication of important risk information, thereby misleadingly suggesting that Rituxan is safer than has been demonstrated,” the FDA said of the materials, which were aimed at doctors.
Genentech spokesman Edward Lang said the company would work to remove all the offending materials.
The FDA released two letters to Shire objecting to sales materials for drugs to treat ulcerative colitis, a painful bowel inflammation.
The agency said a Shire brochure developed for doctors overstated effectiveness and omitted certain information about one drug, Lialda. Another written promotion for doctors made unsupported efficacy claims for the company’s Pentasa drug.
Shire spokesman Matt Cabrey said the company has stopped using the promotions cited by the FDA and is working with the agency to resolve the issues raised in the letters.
