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Is the FDA Too Cautious?

Open to Debate

CHAPTER

The FDA's Response to Pressure

Peter Lorry and Colin Hill: Is the FDA too cautious? John Donven: I think that you perhaps misunderstand the way the FDA does experience pressure. Most of the time when a drug kills people, take Vioxx, for example, right? And if you take it to court on that basis, you are not going to win your malpractice or product liability case. In Congress, the pressure is not on the safety side anymore. It's on the business-friendly efficacy side. That's what the agency's responded to.

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