As the FDA keeps up the pressure on marketers for making unsubstantiated claims in their professional promotions, a Pfizer legal expert says companies may be able to avoid such notices by supporting all advertising claims with substantial evidence.
Timing of FDA notice on diabetes meds leads to confusion
Federal advisors recommended keeping GlaxoSmithKlines embattled type 2 diabetes drug Avandia on the market but said its label should include strict warnings on use.
An advisory group is set to meet Monday to discuss the cardiovascular safety of GlaxoSmithKline’s type 2 diabetes drug Avandia, and the drug may be in for a rough time.
Pfizers ability to reach what may be an untapped population of people suffering from fibromyalgia got a boost last week when Lyrica became the first FDA-approved therapy for the condition.
FDA has asked GSK and Takeda to place boxed warnings of congestive heart failure risks on the labeling for their type 2 diabetes drugs, Avandia and Actos.
The war of words between GlaxoSmithKline and critics of the firm’s oral diabetes drug escalated yesterday, as the marketer took additional steps to shore up confidence in Avandia.
A promotional piece distributed on behalf of Cephalon to the Maryland Department of Health and Mental Hygiene Pharmacy and Therapeutics Committee suggested uses for the company’s Provigil (modafinil) tablets that have not been approved by FDA, creating new intended uses for which the product lacks adequate directions.
Cracking the patient-physician interaction has long proved elusive for pharma. But by combining patient chart data with actual audio conversations, marketers can better understand how to impact the exchange, says Carolyn Choh Fleming