Healthy Skepticism Library item: 17635

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
UPDATE 3-U.S. objects to Glaxo, Novartis drug promotions
Reuters 2010 Apr 16
http://www.reuters.com/article/idUSN1611749520100416

Abstract:

• FDA releases three letters to companies

• Cancer, pain, bladder drug promotions cited

• Website, e-mail, journal ad draw complaints

Full text:

GlaxoSmithKline Plc (GSK.L), Novartis AG (NOVN.VX) and Astellas Pharma Inc (4503.T) used misleading promotions for cancer, pain and bladder drugs, U.S. regulators said in letters released on Friday.

A medical journal advertisement by Glaxo “omits important information” about the safety and effectiveness of cancer drug Arzerra, the Food and Drug Administration said in a letter to the British drugmaker.

In a separate letter, the FDA said a promotional webpage had overstated the effectiveness of Glaxo’s and Astellas Pharma’s (4503.T) overactive-bladder drug Vesicare.

The agency also said a Novartis email to consumers had made misleading claims about pain reliever Voltaren gel.

GlaxoSmithKline has removed the content that drew FDA complaints from the Vesicare website and will not use the Arzerra ad again, company spokeswoman Mary Anne Rhyne said.

“We take the FDA’s concerns seriously” and “are working to resolve any remaining questions and ensure our materials reflect the direction provided by the FDA,” she said.

Astellas spokeswoman Maribeth Landwehr said the Vesicare claims were made on a portion of the website for doctors. Astellas and Glaxo “took immediate action to suspend the area of the product site in question,” she said.

“We are working closely with the FDA to fully understand their comments and address the points they raised,” Landwehr said.

A Novartis spokeswoman said the company was reviewing the FDA’s letter and would with work with the agency to address concerns.

The FDA posted the letters here.