Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads to mislead consumers about the drugs’ effectiveness. While consumers’ concern about drug pricing may be significantly skewed by their insurance coverage, every potential consumer of a drug has a strong interest in the extent to which the drug is likely to provide them with a significant improvement in their health. I conclude that because the ads are likely to be misleading, required disclosures of a drug’s demonstrated level of effectiveness would be constitutional under the commercial free speech doctrine established in Central Hudson and that the FDA can require such disclosures without the need for additional legislation.
Robert A. Bohrer,
Direct-To-Consumer Ads are Misleading: Concise Statements of Effectiveness Should Be Required,
J. Health Care L. & Pol'y
Available at: https://scholarlycommons.law.cwsl.edu/fs/330