Pharmacoeconomic Claims As the 20th century drew to a close and healthcare financing reform ascended on the national agenda, the issue of economic claims in pharmaceutical communications received increased regulatory focus. Claims of safety or efficacy based on cost-effectiveness, outcomes, quality of life, or similar parameters have become the subject of greater scrutiny and are generally required by the FDA to be supported by substantial evidence based on clinical studies or a detailed analysis and documentation of costs. As generally used, the terms cost-effectiveness and cost-benefit refer to systematic economic analytical techniques that compare the negative consequences (costs) of drug therapy with its positive outcomes (effectiveness, or other benefits). A drug is considered to be cost-effective when it achieves the same result as another form of therapy at a lower cost. A drug is cost-beneficial when it confers benefits that exceed costs. For example, studies of vaccines show that they are cost-effective because they prevent diseases at lower costs than treating them. Studies of beta-blocker drugs show that their benefits far outweighed their costs in preventing second heart attacks and in treating glaucoma and angina. The FDA Modernization Act of 1997 (FDAMA) created an exception to the general FDA policy on the communication of healthcare economic information to formulary committees, managed care, or similar organizations. This exception cannot be used to provide pharmacoeconomic information to individual physicians or in advertising. Under FDAMA, such information must have a reasonable basis in fact and must be based on "competent and reliable" healthcare economic information. The economic
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