Thompson v. Western States Medical Center (2002)
- Facts:
- Pharmacists combine ingredients to create specially tailored medications in response to doctor prescriptions. These compounded drugs are exempt from the FDA's standard drug-approval requirements.
- FDA became concerned that some pharmacies were avoiding the standard drug-approval procedures by manufacturing and selling drugs on a large scale under the guise of compounding.
- Consequently, Congress prohibited the advertising or promoting of compound drugs.
- Several licensed pharmacists challenged the ban as a violation of the First Amendment.
- Had often distributed promotional materials by mail and at medical conferences to inform patients and doctors of the use and effectiveness of specific compounded drugs.
- No claim by FDA that the ads were deceptive or for an illegal product.
- Government asserted several reasons for the advertising ban:
- Preserving the effectiveness and integrity of the FDA's drug-approval process and the protection it provides for the public health;
- Preserving the availability of compounded drugs for individual patients who cannot use commercially available products approved by the FDA.
- Achieving the proper balance between those two competing interests
- COURT: Preserving the new drug approval process is clearly an important governmental interest, as is permitting the continuation of the practice of compounding so that patients with particular needs may obtain medications suited to those needs.
- Does the ban directly advance the government's interest?
Court: "Government seems to believe that without advertising it would not be possible to market a drug on a large enough scale to make safety and efficacy testing economically feasible.
"The Government thus believes that conditioning an exemption from the FDA approval process on refraining from advertising is an ideal way to permit compounding and yet also guarantee that compounding is not conducted on such a scale as to undermine the FDA approval process.
"Assuming it is true that drugs cannot be marketed on a large scale without advertising, the FDAMA's prohibition on advertising compounded drugs might indeed 'directly advanc[e]' the Government's interests."
- Does the regulation have a reasonable fit with the interest?
COURT: Regulation fails the fourth prong
Government could:
- Ban the use of commercial-scale manufacturing equipment in compounding drugs,
- Prohibit pharmacists from compounding more drugs than the prescriptions already received, or
- Prohibit them from offering compounded drugs at wholesale to other state-licensed people or companies for resale.
- Government attorneys did not explain why such possibilities, alone or in combination, could not prevent compounding from occurring on such a scale as to undermine the drug-approval process.
"Indeed, there is no hint that the Government even considered these or any other alternatives. Nowhere in the legislative history of the FDAMA or petitioners' briefs is there any explanation of why the Government believed forbidding advertising was a necessary as opposed to merely convenient means of achieving its interests.
"If the First Amendment means anything, it means that regulating speech must be a last--not first--resort."
- Dissenting justices argued that the ban was motivated by a fear that advertising compounded drugs would put people who do not need such drugs at risk by encouraging them to persuade their doctors to prescribe the drugs anyway.
- Majority: "That fear would fail to justify the restrictions. This concern rests on the questionable assumption that doctors would prescribe unnecessary medications and amounts to a fear that people would make bad decisions if given truthful information, a notion that the Court rejected as a justification for an advertising ban."
- Majority: Benefits to advertising compounded drugs.
"Forbidding the advertisement of compounded drugs would prevent pharmacists with no interest in mass-producing medications, but who serve clienteles with special medical needs, from telling the doctors treating those clients about the alternative drugs available through compounding. For example, a pharmacist serving a children's hospital where many patients are unable to swallow pills would be prevented from telling the children's doctors about a development in compounding that allowed a drug previously available only in pill form to be administered another way."
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