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04/04/05 1:05 AM

#17922 RE: Paulness #17920

Paulness, the FDA is not in the business of "curing" people. The agency was created to make sure that drugs, compounds, foods, and medical devices are made in accordance with strict guidelines. For pharma/biotech those would be cGMP guidelines. That those things made and produced by food and drug companies are safe for public use and consumption. They can expedite drugs/medical devices by fast tracking if it is shown that there is a need to do so, as with Panacos PA457 for HIV. Evidence has to be shown that there is a need to do so and that such a process is far enough along as to be ready for phase trials to be expedited. Orphan drug status is also available, but there has to be a need for such a status, and evidence must again be presented.

The FDA is not in the business of curing people though. They leave that up to the pharmaceutical/biotech/medical device companies.