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Constitutional Law Keyed to Choper
Thompson v. Western States Medical Center
Citation:
535 U.S. 357 (2002)Facts
Drug compounding is a process by which pharmacists combine, mix, or alter ingredients to create medications tailored to individual patients’ needs. The Federal Food, Drug, and Cosmetic Act (FDCA) requires all “new drugs” to undergo rigorous safety and efficacy testing before receiving FDA approval. The FDAMA of 1997 exempted compounded drugs from these requirements if pharmacists met several conditions, including refraining from advertising or promoting particular compounded drugs. The respondents, a group of licensed pharmacies specializing in compounding, had prepared promotional materials about specific compounded drugs. Fearing prosecution, they filed a complaint arguing that the advertising restrictions violated their First Amendment rights. The government defended the restrictions as necessary to balance two competing interests: preserving the integrity of the new drug approval process while ensuring the availability of compounded drugs for patients with special needs.
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