I strongly believe that the FDA needs a complete overhaul. However, I adamantly oppose S.1082 - the Food and Drug Administration Revitalization Act of 2007, scheduled for vote in the Senate Monday afternoon, April 30, as well as any House companion bill.

I am outraged that this legislation creates a business relationship between the FDA and private industry for the purpose of designing and marketing drugs (pages 105-125 of the bill). We do not need an “FDA, Inc.” The lack of transparency between FDA management and the pharmaceutical industry is one of my greatest concerns—how could the Senate possibly consider legislation that places the FDA in charge of licensing arrangements with private industry?

As one of the 150 million consumers of dietary supplements, I also find it appalling that S.1082 gives the FDA new powers to attack dietary supplements (pages 106-107). We do not need more legislation that will allow the FDA, at its whim, to suppress access to safe, natural health options and dietary supplements.

This entire package of pharmaceutical industry-friendly FDA reform does nothing to protect myself or my family from another Vioxx catastrophe.

1) I oppose the pharmaceutical industry funding the FDA for new drug approvals, which S.1082 not only allows but increases. This is a conflict of interest.

2) I demand that an independent office within the FDA be set up to monitor the safety of drugs already on the market. The Institute of Medicine has already told us that the FDA’s current management is dysfunctional. I want real reform at the FDA.

3) I want full disclosure of all clinical trials, not the watered-down pharmaceutical industry-friendly version in S.1082 that allows drug companies to hide their problems.

4) I want all conflicts of interest removed from FDA advisory panels. There is no need to have industry-sponsored “experts” voting on drugs which they receive money to promote. S.1082 supports the status quo. It is time for meaningful change.

S.1082 tries to do too much at once and does nothing properly. Under the pretense of drug safety, the real agenda of the legislation is to turn the FDA into a drug company and increase FDA regulatory power that can be used to attack dietary supplements. This 262 page bill was passed out of committee without a hearing, and there is no report on it so members of Congress don’t even know what it contains.
Please vote NO on S-1082 and on the House companion bill.