Biotech Values

[DewDiligence]

Re: FDA mandate

“There is no question that the economic environment has changed dramatically over the last few years. The cost consciousness of payers and those that reimburse drugs has put pressure on the FDA. Although the FDA's mandate says that it is not required to look at the cost-effectiveness of individual medications, there is much more of an acceptance of the fact that it is no longer sufficient of developers of products to simply demonstrate safety and efficacy. They have to demonstrate some sort of cost value. And I think, although the FDA is not mandated to review that information they still feel that pressure.”

—Kenneth Kaitin, Director, Tufts Center for the Study of Drug Development

http://www.cancernetwork.com/practice/content/article/10165/2036366