Off-Label Info OK: So What?
One of the most controversial issues coming out of the recently concluded legislative battle over reforming the FDA involved expanding medical companies' abilities to promote off-label uses of their products. Yet in the end, the ultimate impact of this reform appears to be negligible.
You may also be interested in...
FDA's criticisms of promotional DVD for Abbott's Kaletra highlight pitfalls of celebrity testimonials. FDA says too much of the session with the basketball star focuses on benefits from the drug; risk information is just an afterthought. The interview with the net star also demonstrates FDA concept of inaccurate "net impression." The DVD creates implied claim that drug works for five years - without supporting data.
Revisions to PhRMA’s 2002 voluntary marketing code that go into effect in January delve into the specifi cs of what pharma sales reps are allowed to do and what they should avoid when interacting with health professionals.
With Lucentis sales slumping, Genentech took the bold step of cutting off ophthalmologists from supply of Avastin, further angering providers already seething about the company's maneuvering around an NIH-funded comparative trial. The desperate move of a company painted into a corner? Hardly. Beneath the headlines, it looks like Genentech is going to win the fight to prevent Avastin from becoming standard care for AMD.