Category Archives: FDA and drug studies

Will the FDA ever understand DTC advertising?

UnknownKEY TAKEAWAY: “Two things are infinite: the universe and human stupidity; and I’m not sure about the universe” said Albert Einstein.  I’m beginning to think that can be applied to the FDA when it comes to DTC ads.  Studying animation in DTC ads?  At a time when DTC ads are under attack the FDA should be reassuring attackers that DTC ads benefit consumers and doesn’t lead to patients requesting unnecessary prescriptions. Continue reading

FDA approval no longer means sales

I was talking to our research Director about some recent research findings and surprisingly one of the top line findings is that both consumers and physicians are not in any hurry to try new drugs just because they were newly approved by the FDA.  Why ?  Trust. Continue reading

Avandia: The FDA loses more credibility

Confused-Image1Margaret Hamburg said in 2009  “I want to restore faith and trust in the FDA as a science-driven agency. I want to be a vocal advocate for the resources we require. It’s stunning how underfunded we are given the importance of what we do. 25% of every dollar spent by Americans is regulated by the FDA.”  So if your a patient who takes diabetes drugs what are you to think if your doctor wants to put you back on Avandia given the hearings last week ?  More importantly are you not going to trust the FDA that Avandia is a safe and effective treatment for diabetes ? Continue reading