FACEBOOK: FDA Vs Novartis por Tasigna...

In a faxed letter posted this week to the agency’s website, the FDA told Novartis that the information generated by the “Facebook Share” widget on the drug maker’s website for Tasigna (approved to treat a type of leukemia) runs afoul of FDA regs about disclosure and permitted claims in marketing materials. Clicking on the widget will send Novartis-authored information about the drug to a user’s Facebook page.

“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,” says the letter from Karen Rulli, acting group leader of the division of drug marketing, advertising, and communications. “In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products.” It’s the first time the FDA has issued an enforcement letter over a Facebook widget, an FDA spokeswoman says.

Here’s the Dow Jones Newswires story.

Como apoyo promocional a Tasigna, el sucesor de Glivec, Novartis se decide por las Redes sociales...
Facebook, en concreto, donde "remite" a los visitantes a la web del producto...

Este proceder no es del agrado de la FDA que establece medidas correctivas (abajo) al considerar que:

1. Se omiten los riesgos del producto
2. Se "amplian", sin autorización legal, las indicaciones
3. Se sobreestima la superioridad y eficacia
4. No cumple con los trámites de autorización debidos (Form 2253)

Digitas Health Facebook Regulatory Alert 20100805