A nice essay from the FDA assistant commissioner who resigned in protest of the Bushistas' incursion into scientific decisions at the agency.
Since my resignation six months ago as assistant commissioner of women's health at the Food and Drug Administration, I have been traveling around the country meeting with men and women, fellow scientists and health care professionals. I have shared my concerns that our federal health agencies seem increasingly unable to operate independently and that this lack of independence compromises their mission of promoting public health and welfare.
At every stop I am reminded that whether it is the environment, energy policy, science education or public health, the American public expects our government to make the best decisions based on the best available evidence.
Yet, at a recent hearing of the House Appropriations subcommittee on labor, health and human services, we saw once again that this is not happening. Reps. Sam Farr (D-Calif.) and Rosa DeLauro (D-Conn.) questioned FDA acting commissioner Andrew C. von Eschenbach about the delay in approving the application to make Plan B emergency contraception available over the counter to women 17 and older. Von Eschenbach responded that the agency was carefully reviewing the thousands of comments received in response to last-minute concerns raised about the feasibility of making the same product available over the counter for most women but keeping it on prescription for young teens. This exchange confirmed my suspicion that, like his predecessor, von Eschenbach is unable or unwilling to let the science and the scientists guide FDA policy and decisions, and that the real answer as to whether the FDA will allow Plan B over the counter for those 17 and older is no.
Time and again in my travels I am asked, "What happened to derail Plan B?" I have to answer honestly that I don't know. The manufacturer agreed to take the "controversial" issue of young teens' access to emergency contraception off the table in 2004; now we are talking only about adult access to safe and effective contraception. Over 98 percent of adult women have used some form of contraception. So what is the objection?The rest is at
http://www.washingtonpost.com/wp-dyn/content/article/2006/02/28/AR2006022801027.html
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