Save the FDA!
Out in internet land, some people are proposing to eliminate the FDA. Stella from ReasonPharm wrote about this issue on Monday and agreed, suggesting that other organizations, such as the media, independent licensing agencies, or clinical groups that develop practice guidelines might be able to step up and take over the FDA’s role. Eliminating the FDA is perhaps one of the most ridiculous ideas for “health care reform” that I’ve heard of in a while, and half of the arguments people are using to support its elimination are about things that fall out side of the FDA’s domain. While the FDA has been around for about a century, its modern form has existed only since 1962, when the U.S. responded to the Thalidomide tragedy (if you’re not familiar with this, photos after the jump) by charging the FDA with evaluation of drug safety and efficacy.
The FDA is not the cause of high drug costs. The FDA is notsecretly holding back cures for cancer, diabetes, or HIV/AIDS. Without FDA regulation, consumers would have no way to determine the efficacy and/or safety of drugs unless they were individually reviewing clinical trials literature. In actuality, it is the FDA that compels companies to conduct trials, so without it, companies may not have the same incentives to conduct Phase III trials and actually demonstrate a drug’s efficacy. While I’m sure some people out there who are physicians with PhDs in biostatistics might be able to review the literature and make their own call on a drug’s suitability for use, I don’t see this as a viable solution for the American people in general. The FDA might have issues, but its elimination or privatization would only open the door to more insidious conflicts of interest. Instead, we should direct more funding towards the FDA, pay its reviewers and officers well enough to dissuade them from external financial relationships that might lead to a conflict of interest, and promote it as a body that is protecting the safety and health of patients and consumers.
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POSTED IN: Policies and Politics
3 opinions for Save the FDA!
Lynnette
May 29, 2008 at 10:46 am
RE the woman who was giving her neice a “pill” to make her imaginary ills bettr…Is it a good idea to teach children that pills will cure all their ills? I don’t think so! Maybe just talking to the girl to find out why she is “sick” all the time would be a healthier way to handle the situation.
CMC guy
May 29, 2008 at 4:19 pm
Although I agree getting rid of the FDA is extreme view there are a couple problems I have in response to your post.
Much of the Phase III studies companies are “compelled” to do have to be a design to target rigid statistical measures demanded by current FDA so do increase costs and time of development thus impact costs significantly. I understand the complexities and the need for application of biostatistics yet these are now so dominate the patients and other factors seem lost in the evaluations. There has to be balance of consistency and flexibility which admittedly can be tough to execute on.
How much do you have to pay an FDA reviewer so they are not tempted by outside influences? The conflict of interest issue as stated is misaligned just as with the argument that User Fees give industry undue influence (if so then rebates are in order). There should be more funding to grown and maintain expert staff, plus provides tools and resources they need. The FDA folks have expertise should respect and appreciation for the hard job they do (which should indeed include better salary scales) but they also need to be able to change and adapt elements that are not working.
Thanks
Blue Heron
Jun 28, 2008 at 3:18 pm
The FDA is all we have however they have not been doing a very good job protecting the public for quite some time. If the notion is that they should stick around then they need to be dismantled and restructered. Many of the movers and shakers in the FDA once they leave go on to work for Big Pharma or become a lobbyist for some group to influence decisions within the FDA. Its a revolving door and lets not forget that some have invested in stocks in some of the Big Pharma companies. Starting with the Vioxx debacle and moving on to today’s tainted tomatoes and numerous appearances in front of congress to explain their screw ups I can certainly see that perhaps this is a level of government we can do without since they are charged with protecting the health and well-being of the public and have not done a good job at all. How many more people will become casualties because the FDA has continuall failed to do its job?
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