FDA: Standards Need to Be Maintained

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Thomas Stossel, MD, Professor of Medicine at Harvard presents a rebuttal in Forbes (How to Maintain FDA Standards) to a dangerous editorial in the Boston Globe by Marcia Angell-Relman, MD former Acting Editor of New England Journal of Medicine and Pharmascold leader.

I actually penned a rebuttal myself earlier but never published it.  I wrote it from the perspective of “a nothing and a nobody” a phrase that journal editors have been using lately on their critics. 

Dr. Stossel does a much better job at outlining the problems with Angell’s recommendations.

Angell’s recommendations which border on crazy (punish manufactures vs. saving lives) include, eliminating the “user fees” companies pay to the FDA to review their medications.  Marcia has forgotten that the fees were adopted to help pay for quicker reviews which has resulted in thousands of saved lives. 

Excluding consultants, ban on DTC, preventing multiple entries in a drug class (the me too syndrome).   Dr. Stossel points out that many times the first drug approved in a class may not be the best drug and in some cases may be

Dr. Stossel points out that in short Angell’s calls for reform would lead to decreased patient access to lifesaving new products, higher drug prices and less competition between pharmaceutical companies.  As public policy, that’s a prescription for bad health.

Forbes:  How to Maintain FDA Standards

 

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