Posted by Gary Schwitzer in Drug industry
The Dow Jones Newswire carries a story that tells us:
“The U.S. Food and Drug Administration said Novartis AG’s (NVS, NOVN.VX) use of a Facebook tool on the website for cancer drug Tasigna violated regulations by presenting misleading information about the drug.
The agency also said in letters posted on its website this week that Novartis used a misleading brochure for its blood-pressure drug Exforge, and that AstraZeneca PLC (AZN, AZN.LN) used misleading promotional material for the antipsychotic Seroquel.
The FDA said the U.S. website for Tasigna has a “Facebook Share widget,” or a button that users can click on to generate Novartis-created information about the drug, which visitors can share with other Facebook users.
“The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug,” the FDA said in a July 29 letter to Novartis, which the agency posted on its Website Wednesday.
Drug companies have approached social media sites like Facebook and Twitter gingerly because the companies must comply with federal regulations requiring balanced presentation of risks and benefits for prescription drugs.
Tasigna is approved to treat a form of leukemia and is Novartis’s follow-up to its blockbuster drug Gleevec. Tasigna is associated with serious risks including sudden death and liver-function abnormalities.
The FDA also took issue with Novartis’s description of Tasigna as a “next-generation” treatment in some of the Facebook-shared content. The FDA said it has previously sent written advisory comments to Novartis about the misleading implications of the phrase “next-generation” when referring to Tasigna.”
All that glitters is not gold.
Addendum on August 9: I missed this one from last week:
Dendreon Corp exaggerated the benefits of its novel prostate cancer vaccine and downplayed risks in some sales materials for the product, U.S. regulators said in a letter released on Friday.
“These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge,” the U.S. Food and Drug Administration said in a letter to the company.
Some of Dendreon’s promotions included a chart that “does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of” the company’s main study, the FDA said.