The Triumph of Science
Over FDA Politics

It's hard to believe that until the 1960s, commercial free speech was more the rule than the exception in the medical arena. The FDA had no power over what could be said about a drug if the message was truthful and not misleading. The FDA was not empowered to regulate what was said. It was not their mission to determine whether something "worked" or not.

Then an exceptional drug called thalidomide - which (surprise) recently has been approved for cancer, leprosy, tuberculosis, and AIDS-related illnesses - was marketed as a tranquilizer in European countries, with disastrous consequences. Thousands of babies whose mothers had taken it without knowing that it could affect the fetus were born with severe defects. Exactly what did the FDA do? It dragged its feet and declared itself a hero for keeping thalidomide out of the U.S., even though it did so for the wrong reasons. The FDA didn't discover the causal connection. Europeans did. In fact, until 1961 - after all the damage was done - no reproductive tests were done at all on thalidomide. They wouldn't have worked anyway, because thalidomide doesn't cause birth defects in mice.

POWER - THE UNDESERVED REWARD
So what happened? Politicians rewarded the FDA for its foot-dragging by passing a bill that had previously been stalled in Congress. Called the Kefauver Amendments to the Food, Drug, and Cosmetic Act, this bill gave the FDA new power not only over the safety of new drugs, but also over their efficacy. This was ironic, because thalidomide was a safety issue and not one of efficacy. Giving the FDA new power to regulate was a prime example of the way the bureaucratic mind works: Solve a problem, no matter the cost, even if it means trashing first principles, i.e., the Constitution.

For years the FDA, with the support of its congressional friends, has been wildly expanding its regulatory authority and its legislative mandate . . . strangely, but not unprofitably, unopposed by the pharmaceutical industry. But that may soon change.

ENDING THE FDA "MONOPOLY" ON TRUTH
"Congress shall make no law . . . prohibiting . . . freedom of speech, or of the press . . . ," reads the most salient part of the Bill of Rights of the Constitution: the First Amendment. That doesn't mean some law; it means NO law. So it is about time, almost forty years after the Kefauver Amendments, that some members of Congress are planning to undo the power of the FDA to maintain a monopoly on truth. On June 8, 2000, Congresswoman Helen Chenoweth-Hage (R-ID) and four House cosponsors introduced a bill (H.R. 4604) that amends the Food, Drug, and Cosmetic Act to compel FDA compliance with the First Amendment and to protect freedom of choice in the dietary supplement marketplace, consistent with the 1999 Pearson v. Shalala court decision.

By eliminating the current "significant scientific agreement" health-claim review standard and replacing it with a First Amendment standard, this bill, if passed, will smash the FDA's stranglehold on truth. It will apply to food and dietary supplements and to all nutrient-disease relationships, including claims to cure, treat, mitigate, or prevent disease. Among other rights restored, this bill will prohibit the FDA from denying any health claim made by nutrient advocates unless there is no scientific evidence supporting it and as long as the claim is not misleading.

Moreover, all claims will be automatically authorized if the FDA does not act in 100 days, and if a claim denial is objected to by the petitioner, the FDA is required to file a declaratory statement with the United States Court of Appeals for the D.C. Circuit - the same court that found in favor of Pearson v. Shalala! If the FDA loses, it must pay the petitioners' legal fees and costs out of its own regulatory budget. The bill also renders null and void all past health-claim denials by the FDA and grants all the Pearson claims and every other claim previously denied by government authoritative statements.

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