Congress and the FDA
* David Willman’s report on FDA policies (Dec. 20) correctly analyzes the many difficult issues and conflicting pressures the agency faces in regulating the approval of new drugs. Missing from this analysis, however, is the not inconsiderable pressure the agency has had from Congress to let down the barriers and to speed up the approval process. Following the 1994 conservative revolution, Dick Armey, Tom DeLay, Newt Gingrich and their ilk harassed David Kessler and other FDA administrators to desist from “impeding progress.”
With its passage of the Dietary Supplement and Education Act, Congress, in fact, created a gaping loophole for the use of many inadequately tested drugs to be used as “dietary supplements.” Some of these are now proving to be dangerous to health. This is the same crowd that has prevented the FDA from having any authority over the use of tobacco products, the leading cause of premature death in America.
It was, in part, because of this partisan politicization of the process that Kessler, Rudolph M. Widmark and others threw in the towel and resigned.
LAWRENCE D. LONGO MD
Center for Perinatal Biology
Loma Linda University
School of Medicine
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