The FDA: Neither Safe nor Effective: The Dictates of the FDA Are So Ingrained in Society That We Seldom Question Whether They Save Lives. in Actuality, Studies Show That FDA Rules Lead to Increased Deaths

Article excerpt

Once upon a time, so the story goes, the American pharmaceutical industry was a "wild West" in which greedy, unscrupulous snake-oil salesmen preyed on unsuspecting citizens. Average Americans, in the same tale, were incapable of sifting through the claims of drug purveyors and of determining which drugs were both safe and effective, and thus were suffering and dying in droves at the hands of these conniving profiteers. The happy ending to the story is that the federal government, in response to public outcries for salvation, stepped in and forced all drug manufacturers to prove their products were safe and effective before they could sell them; henceforth, Americans could be certain that no drugs would ever harm them again.

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Would that it were so simple. In fact, say economists Daniel B. Klein, Ph.D., and Alexander Tabarrok, Ph.D., not only is the back story in that familiar yarn sorely lacking an historical basis, but the very idea that federal premarket approval of drugs is beneficial is also greatly in doubt.

Klein and Tabarrok are the authors of an Independent Institute project called FDAReview.org that examines the question "Is the FDA safe and effective?" The two men conclude that it is neither, writing that "FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits" and that "FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of morbidity and mortality."

They do not, however, place the majority of the blame on the FDA itself but rather on the legislation that created the FDA and has steadily expanded its duties and powers. The FDA's initial responsibilities were small and relatively innocuous; as Congress has piled more mandates onto the agency, its delays have increased and its effectiveness has decreased.

The Evolution of Regulation

Klein and Tabarrok begin their study with a detailed overview of the history of federal drug regulation. They write that "before the twentieth century there was no direct federal regulation of drugs or other consumer products," yet somehow Americans managed to survive and prosper just the same.

While it's true that the pharmaceutical industry was also relatively small prior to 1900, with most drugs being mixed by hand at local pharmacies, pharmacists and doctors had already undertaken to improve the safety and quality of the drugs being sold to consumers. For example, in 1820 the U.S. Pharmacopoeia was created. "A private, voluntary undertaking of physicians, pharmacists and colleges of pharmacy, the USP presented a formulary of compositions and listed chemical compounds, crude drugs, fixed oils, and other substances typically kept by a pharmacist," explain the authors. "Later the USP listed tests for determining purity. Leading pharmacists regularly revised the USP as new and better drugs, compositions, and tests were discovered and created." The American Medical Association and the American Pharmaceutical Association were formed; the latter began publishing the National Formulary, whose function is "to provide standards for drugs omitted from the USP and to serve as a proving ground for drugs eventually transferred to the USP," in 1888. In short, long before the FDA was even a gleam in Uncle Sam's eye, the pharmaceutical industry was regulating itself.

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Klein and Tabarrok point out that crises have played a large part in Washington's increasing control over the pharmaceutical industry. The very first significant federal drug regulation, the Biologics Act of 1902, was passed in the wake of a vaccine contamination scare. The act, write the economists, "required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. Never before had such premarket control existed in the United States. …