It’s hard to feel too sympathetic to a pharma company and today is no exception. On Friday, the Food and Drug Administration said an advertisement for a GlaxoSmithKline PLC cancer drug was "false or misleading."
Specifically, an advertisement that ran in a cancer medical journal involving Glaxo's drug Arzerra omitted "important information about the drug's safety and effectiveness," the FDA said in a letter to the company that was posted on the agency's Web site.
How? According to Fiercepharma.com, the company left out "important information" about its cancer med Arzerra when it published an ad in a medical journal.
The agency wasn't happy that GSK didn't include full safety and efficacy info, even though the ad didn't state Arzerra's name. It did include characteristics--such as specifics on its use--that could only describe Arzerra, FDA states, making it a "product-specific prescription drug ad for Arzerra."
I’m sure it was an innocent mistake.
Not to worry, they aren’t alone. The FDA was handing out complaints left and right last week.
For more:
Wall Street Journal article
http://online.wsj.com/article/SB1000142405270230349130457518850107013149...
Fierce Pharma
http://www.fiercepharma.com/story/fda-cites-promos-astellas-novartis-and...
