On the recordApril 27, 2005
today I introduce Senate Bill 930, the Food and Drug Administration Safety Act of 2005. I am pleased that Senator Dodd is co-sponsoring another piece of drug safety legislation with me. This legislation is part of a sustained effort to restore public confidence in the Federal Government's food and drug safety agency. Enactment of this bill will be another meaningful step toward greater accountability and transparency at the FDA. Importantly, this legislation provides the FDA with some much needed authorities to ensure the safety and efficacy of drugs for the long haul. The Food and Drug Administration cannot always serve the American people and the interests of the drug industry at the same time. These two interests are often at odds with each other. When there is a conflict the American people should win out each and every time. The Vioxx situation is a classic example of this inherent conflict. American consumers demand and deserve assurances that the medicines in their cabinets are safe. The risks associated with a drug should be outweighed by its benefits, and this risk-benefit analysis should not be negotiated by the industry behind closed doors. Unfortunately, reforms at the FDA are necessary to place drug safety front and center once and for all. When drugs go on the market, they are used by exponentially larger numbers of people than were involved in the pre-approval trials. What John Q.…
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