Posted: September 25, 2006
The Institute of Medicine (IOM) just released its report entitled "The Future of Drug Safety: Promoting and Protecting the Health of the Public" in which it said, among other things, "FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry."
In this post, I outline the major recommendations of the report and focus on two things of interest to me and hopefully to you as well:
- PhRMA's response to the report falls short, IMHO. Should the industry be happy with a "good" drug safety/recall record or should it strive for "excellent" as it does in manufacturing and marketing?
- IOM calls for a 2-year moratorium on DTC for newly approved drugs, which is an idea taken right from Senator Frist's play book! (See "Deconstructing Frist on DTC").
Read more about the report in today's post to Pharma Marketing Blog.
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