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Freedom Lover's avatar

In Free to Choose, Milton Friedman explains not only how to make FDA great, but also why we don’t need it at all.

Do we have what it takes to get rid of FDA?

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Brian Hasselbalch's avatar

Your first recommendation, i.e., eliminate GMPs for Phase 1 trial drugs, is based on a misunderstanding. In fact, FDA issued a final rule in July 2008 exempting Phase 1 drugs from the full GMP regulations and issued guidance that same month on what GMPs such drugs should follow. That guidance has about 8 pages of recommendations, and includes two sentences on stability:

"We recommend initiation of a stability study using representative samples of the phase 1

investigational drug to monitor the stability and quality of the phase 1 investigational drug during the clinical trial (i.e., date of manufacture through date of last administration)."

If a drug degrades significantly during the clinical study period it may cause direct harm and perhaps lead to a false conclusion about the drug's safety.

FDA rarely inspects clinical trial production and has always preferred a light regulatory touch at this stage of drug development. FDA reform is needed, but would prefer it be based on the truth and data.

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