Margaret Hamburg's comments this week indicate a predisposition in the FDA to consider accelerated drug approvals for "special medicines" that provide societal benefits despite their possible risks. These would include treatments for conditions like obesity or life-saving antibiotics.
In keeping with recommendations handed down by a White House advisory committee last week, Hamburg told scientific advisers that the agency is considering letting makers of such products conduct faster trial with smaller patient groups. The idea is to get drugs faster to patients in dire need.
The plan would also allow drug companies to get products on the market quicker and may provide some level of respite to companies who need to fill revenue holes due to patent expirations of top selling products.
"This is an issue of having the right science and data to assess risks and benefits but also a broader societal discussion about risks and benefits that individuals and communities are willing to take on and under what circumstances," said Hamburg.
I like the idea of trying. In particular, I'm intrigued by passing some responsibility for risk to certain high risk patient classes for diseases like obesity treatment. It is interesting to me because many obesity issues relate to patient [high risk] behaviours in the first place. Getting treatment for some of these type of patients might provide high levels of benefit.
Still, we need to look at the science to make sure risk is not ridiculously high in approving these drugs, and post-market surveillance will need to be bolstered too. Regardless, I think it is an idea that I would like to see tried on a pilot basis. See Bloomberg News.
Posted by Bruce Lehr Oct 12th 2012.