FDA–Safe and Effective?

Here’s my question:  If the FDA had to go through a “clinical trial” to prove that it was safe and effective, would it be able to demonstrate either?

Could it show that the lives saved by its regulatory activities , when compared to lives lost because drugs and devices were delayed or denied, yielded a demonstrably positive result for its actions?

Could it demonstrate that the pain and suffering of patients due to ineffective or injurious drugs and devices avoided or eliminated by its enforcement actions was greater than the pain and suffering of patients due to therapies delayed, denied, or withdrawn from the market?

Vioxx was withdrawn from the market by FDA enforcement action, after it was determined that the side effects were too great, and yet the 95% that experienced no such side effects have been denied a drug that was a godsend for pain management.

I’d like to see the FDA subject to an “environmental impact report” in which it must demonstrate its value to continue its existence.

For more information about the FDA, its history, its effectiveness, and some viable free market reform options you are welcome to go to www.fdareview.org.

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One Response to FDA–Safe and Effective?

  1. Mike Mitchell says:

    I hate to put too much store on one success but the thalidomide created a lot of havoc around the world except for the U.S.A. where it was felt that more testing was required. Also not much media attention is paid to trials that have shown a product is dangerous and therefore not licensed by the FDA.

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