Thompson v. Western States Medical Center
Headline: Ban on advertising specific compounded drugs struck down, allowing compounding pharmacies to promote particular treatments and restore information flow to doctors and patients.
Holding: The Court held that the FDAMA’s ban on advertising and soliciting for particular compounded drugs is an unconstitutional restriction on commercial speech, so those speech-related provisions cannot be enforced.
- Makes it lawful for compounding pharmacies to advertise specific compounded drugs.
- Allows doctors and patients to receive more information about tailored medications.
- Limits FDA’s ability to use advertising bans to curb pharmacy promotion.
Summary
Background
A group of licensed pharmacies that specialize in compounding drugs challenged parts of a 1997 federal law. The law lets pharmacies sell compounded drugs without full FDA approval only if they meet limits, including that prescriptions be unsolicited and that pharmacies not advertise particular compounded drugs. The pharmacies had sent promotional materials to doctors and patients and sued after fearing prosecution. Lower courts held the speech-related advertising and solicitation restrictions unconstitutional and the Supreme Court agreed on the constitutional question.
Reasoning
The Court asked whether the advertising ban was a permissible regulation of commercial speech. Applying the established commercial-speech test, it concluded the government did not show the ban directly advanced its public-health interests or that quieter alternatives were unavailable. The Court emphasized that the government must justify restrictions on truthful commercial information and that non-speech rules could draw lines between small-scale compounding and large-scale manufacturing. Because the government failed that burden, the advertising and solicitation provisions were unconstitutional.
Real world impact
The ruling prevents enforcement of the FDAMA provisions that forbid advertising particular compounded drugs. Compounding pharmacies can more freely tell doctors and patients about specific tailored medications. The decision does not address other parts of the FDAMA outside section 127(a) nor the Ninth Circuit’s severability ruling, which the Court did not review.
Dissents or concurrances
A concurring Justice agreed in result but criticized the test used. A dissenting opinion argued the advertising ban protected public health by reducing demand for untested drugs and favored keeping it in place.
Opinions in this case:
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