Should the Kefauver-Harris Amendment be repealed?
Article Type: Editorial
Subject: Dietary supplements (Labeling)
Dietary supplements (Laws, regulations and rules)
Pharmaceutical industry (Labeling)
Pharmaceutical industry (Prices and rates)
Pharmaceutical industry (Laws, regulations and rules)
Author: Gaby, Alan R.
Pub Date: 08/01/2010
Publication: Name: Townsend Letter Publisher: The Townsend Letter Group Audience: General; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2010 The Townsend Letter Group ISSN: 1940-5464
Issue: Date: August-Sept, 2010 Source Issue: 325-326
Topic: Event Code: 970 Government domestic functions; 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime; 740 Commodity & service prices Advertising Code: 94 Legal/Government Regulation Computer Subject: Government regulation; Company pricing policy
Product: Product Code: 2834730 Nutrient Preparations NAICS Code: 325412 Pharmaceutical Preparation Manufacturing SIC Code: 2833 Medicinals and botanicals; 2834 Pharmaceutical preparations
Organization: Government Agency: United States. Food and Drug Administration
Legal: Statute: Food, Drug and Cosmetic Act
Accession Number: 236643229
Full Text: In the early 1960s, thousands of children in Europe were born with serious birth defects after their mothers took thalidomide for morning sickness during pregnancy. As a result of the thalidomide tragedy, the US Congress passed the Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act. Previously, drug companies had been required to provide evidence that a new drug was safe before it could be approved by the Food and Drug Administration (FDA). The Kefauver-Harris Amendment added the requirement that drugs also be proven effective before they could be approved.

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Using the thalidomide scandal to add an efficacy clause was disingenuous from the start, because the existing Food, Drug, and Cosmetic Act was already strong enough to prevent thalidomide from being approved in the US on safety grounds (which is why the birth defects occurred in Europe but not in the US). What the Kefauver-Harris Amendment did accomplish was to give the FDA greater control over the drug-approval process and to make it enormously more expensive and time-consuming to have a new drug approved. As it stands now, there is little chance that a company that has less than $250 million to invest would be able to have a medicinal substance approved by the FDA. That limitation applies to virtually all natural substances (including vitamins, minerals, amino acids, herbs, and phytochemicals), which cannot be patented and therefore cannot be sold for monopolistic prices, and therefore are not worth a $250 million investment.

One of the FDA's policies regarding unapproved medicinal substances is that it is illegal for manufacturers to disseminate truthful scientific information regarding the therapeutic effects of these substances. "Structure-function" language is allowed by the FDA, such that it is acceptable to say that vitamin K improves vascular calcium balance (a rather useless bit of information from a clinical standpoint), but it is not acceptable to cite published research suggesting that vitamin K prevents coronary artery calcification (which is much more useful clinical information). If a manufacturer disseminates truthful but "unapproved" information, the FDA has the power to declare the medicinal substance in question "misbranded" and to seize it from the warehouse and remove it from the shelves. These prohibitive restrictions were not specifically written into the Kefauver-Harris Amendment, but they apparently arose from the FDA's drug-industry-friendly, anti-natural-medicine, authoritarian interpretation of the amendment.

Prior to the passage of the Kefauver-Harris Amendment, potassium magnesium aspartate was being sold by Wyeth Laboratories (under the name Spartase) as a treatment for fatigue. Several controlled trials had demonstrated this product to be safe and effective for fatigue. However, with the passage of the new law, Wyeth decided that it was too expensive to put Spartase through the stringent new FDA approval process. Consequently, it removed the product from the market. Potassium magnesium aspartate is now available through a number of companies that sell nutritional products, but in keeping with the FDA's offensive interpretation of the law, it is illegal for those companies to tell anyone what the product is for. The same restriction applies to almost all of the many hundred of other natural products that are on the market.

In addition to stifling natural medicine, current law can give physicians a false sense of security regarding the safety and efficacy of the drugs that they are prescribing. Contrary to the assumption that might be drawn from FDA approval, many approved drugs are far from safe, as indicated by the hundreds of pages of adverse reactions and the numerous "black box" warnings in the Physicians' Desk Reference. And while FDA approval does suggest that a drug has some degree of efficacy, it does not guarantee that the beneficial effects outweigh the risks or that the drug is worth the price. There is no doubt that, for some doctors, FDA approval is viewed as a license to prescribe without carefully analyzing risks, benefits, and cost-effectiveness. Conversely, some practitioners erroneously assume that if a natural substance has not been granted FDA approval (which is nearly all of them), it's because the product does not work.

Repealing the Kefauver-Harris Amendment (or at least the clause that refers to demonstrating efficacy) would level the playing field by making it far easier for natural substances obtain FDA approval. On such a level field, practitioners would have a much wider choice of therapeutic agents. Since natural-medicine vendors would no longer be forbidden from disseminating truthful scientific information, practitioners would also have a more complete knowledge base from which to make therapeutic decisions. And as a side effect, drug companies would be deprived of their most widely used explanation for why they charge such obscene prices for their drugs (i.e., they have to recoup their huge investment).

Alan R. Gaby, MD
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