Bill Clinton: “for many years, the FDA has been considered the gold standard among the world's drug safety bodies. And no one here…”

“for many years, the FDA has been considered the gold standard among the world's drug safety bodies. And no one here doubts the desire of the agency's many career employees to continue to carry out its mission of keeping our drug supply safe for all Americans. In the legislation we are considering today, S. 1082, the Food and Drug Administration Revitalization Act, we provide these dedicated employees with the resources necessary to continue their work to ensure the safety and efficacy of drugs and biologic products for Americans. Despite the dedication of the FDA's employees, we know there have been breakdowns at the agency. We know that, at times, it has taken too long to act when a drug may pose a threat. It took many months from the point when scientists became aware of the elevated risk of adverse cardiovascular events associated with Vioxx and the point when it was withdrawn from the market, during which time the FDA had multiple opportunities to engage in stronger actions to protect consumers. In recent years, we have seen the scientific process unduly influenced by political or economic factors.”