When drugs are allowed into the market before their side effects are fully evident, the potentially deadly results are all too familiar: Think of drugs like Trasylol and Ketek. The Institute of Medicine is calling for reducing conflicts of interest among FDA advisory panel members. A few weeks ago, the FDA adopted some of those suggestions. It proposed to exclude from advisory panels all doctors and scientists with financial ties of more than $50,000 in the previous 12 months to the products under review; those with a lesser financial interest could still serve on the committees, but only as nonvoting members.
Yet the weak Senate bill allows paid consultants, scientists with stock in the companies, and other financially conflicted experts to vote on FDA advisory committees -- as long as their financial ties are made public and the FDA grants a waiver.
And, the bill would also create a new foundation, also funded by drug companies, to do the kind of drug safety research that the FDA should be doing.
This month, Ted Kennedy is expected to attach provisions of his drug safety bill to another measure that, among other provisions, expands the user fees that are charged to pharmaceutical companies to pay for drug reviews. Meantime, the FDA itself proposed several changes that Congress should build on -- but hasn't.
Source: http://www.boston.com/news/globe/editorial_opinion/oped/articles/2007/04/17/adding_bite_to_fda_screening/
