In essence, Washington Legal Foundation v. Friedman and Pearson v. Shalala may have actually undermined a large portion of the FDA regulatory power over prescription drugs. Although manufacturers are still required to receive pre-market approval of a new drug, once approved the manufacturer could promote, label, and advertise the drug for other indications. This provides manufacturers with a prime opportunity to get approval for a "cheap, narrow indication and the next day begin selling the drug for multiple broad, and profitable other indications." As the use of a prescription drug changes, the safety and efficacy changes as well. By allowing drug manufacturers to label and advertise off-label uses to the general public, the potential harm to the public's health and safety increases dramatically. ... However, under the Central Hudson analysis, the government's substantial interest in protecting the public's health and safety is directly advanced by prohibiting drug manufacturers from labeling and advertising off-label uses on prescription drugs. This prohibition is no more extensive than necessary because it still allows physicians access to the off-label use information using other forms of communication with the drug manufacturer and the alternative, mandating disclaimers, is not sufficient to prevent consumer confusion. Therefore, the FDA's prohibition of off-label use labeling and advertising does not violate the drug manufacturer's First Amendment rights.
"Is the FDA's Nose Growing? The FDA Does Not "Exaggerate Its Overall Place in the Universe" When Regulating Speech Incident to "Off-Label" Prescription Drug Labeling and Advertising,"
Akron Law Review: Vol. 35:
3, Article 4.
Available at: https://ideaexchange.uakron.edu/akronlawreview/vol35/iss3/4