Reforming the FDA

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 6 No. 4 • September 2003

Reforming the FDA

Nobel Prize-winning economist Gary Becker has said, “Eliminating all requirements except a reasonable safety standard would vastly reduce drug prices in the U.S., as companies would be encouraged to develop additional compounds to compete for customers.” The 1962 Kefauver Amendments to the Food, Drug, and Cosmetic Act that required proof of efficacy as well as safety of new drugs have had a dramatically negative effect on the number of new drugs developed, the time it takes to develop them, and the affordability of those drugs. Unfortunately, this isn’t just a matter of economics and science, but of politics. There are many special interests and those who represent them (e.g., Henry Waxman, Ted Kennedy, Center for “Science” in the Public Interest, FDA, and many others) who would fight tooth and nail the repeal of the Kefauver Amendments.

That is why it is so important to fight for the freedom we have now in the dietary supplement industry. It is one of the few comparatively free markets in medicine left in the U.S. (in fact, the only other one we can think of is compounding pharmacy, which is exempted from FDA’s Good Manufacturing Practices for drugs. See our first [in last months issue of Life Enhancement] and second sets of comments to the FDA on proposed CGMPs (Current Good Manufacturing Practices) for dietary supplements that follow this newsletter for our take on the destructive effects of drug CGMPs, after which the FDA modeled their proposed rule on dietary supplement CGMPs. (The latter is a violation of the law, as the DSHEA authorized the FDA to put CGMPs “modeled after food CGMPs” in place for dietary supplements.)

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