Price Competition

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 6 No. 3 • June 2003

Price Competition Between Dietary Supplements and Prescription Drugs Cannot Occur without Treatment Claims for Supplements

As we discussed in our last newsletter (April–May 2003), we and coplaintiffs have sued the FDA for violating our First Amendment free speech rights in prohibiting truthful statements on labels and in ads about the effects of dietary supplements on the treatment of an existing disease. The example we are using as the basis for the suit is saw palmetto, for which we seek to make the claim, “Consumption of 320 mg of saw palmetto extract daily may improve urine flow, reduce nocturia, and reduce voiding urgency associated with mild benign prostatic hyperplasia.” The claim is truthful and nonmisleading, yet the FDA has refused to review the claim, saying that a “treatment” claim is not permitted under the health claims provision of DSHEA. That is not true, and even if it were, the First Amendment prohibits government censorship of communication of truthful and nonmisleading information. For details on the saw palmetto suit, see In fact, we argue that the information that we propose to communicate is scientific information that should receive full First Amendment protection, whether there is a commercial motive for saying it or not.

One of the consequences of our winning this suit would be that there would be direct competition between dietary supplements and prescription drugs that treat the same disease or symptoms of disease. It would result in price competition that would, at least at first, be highly unfavorable for many expensive prescription drugs. We found a good example in the New England Journal of Medicine1 recently. Acetylcysteine is sold as a prescription drug with disease treatment claims (for example, it is used to treat acetaminophen poisoning), while it is also sold as a dietary supplement for which no treatment claims are permitted (unconstitutionally) by the FDA. The article1 listed 1 gram of acetylcysteine as costing (2000 prices) $5.05 (Medicare) and $3.38 (catalog). The price of the same amount of acetylcysteine as a dietary supplement today is roughly $0.30 (the cost of 1 gram of cysteine, which we use rather than acetylcysteine, is about $0.20). There is currently very little competition between acetylcysteine as a dietary supplement and as a prescription drug, because of FDA information censorship (protecting the interests of pharmaceutical companies that do not want to compete, but damaging the interests of consumers, while driving up the costs of Medicare to hapless taxpayers).

  1. Iglehart. Medicare and drug pricing. N Engl J Med 348(16):1593 (Apr 17, 2003).

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