Thompson v. Western States Medical Center

152 L. Ed. 2d 563, 15 Fla. L. Weekly Fed. S 217, 122 S. Ct. 1497, 535 U.S. 357, 70 U.S.L.W. 4275, 2002 U.S. LEXIS 3035, 2002 Daily Journal DAR 4627, 2002 Cal. Daily Op. Serv. 3663
Supreme Court of the United States·Decided April 29, 2002·No. 01-344·Published·Cited by 274 cases

Opinions

[360]*360Justice O’Connor

delivered the opinion of the Court.

Section 127(a) of the Food and Drug Administration Modernization Act of 1997 (FDAMA or Act), 111 Stat. 2328, 21 U. S. C. § 353a, exempts “compounded drugs” from the Food and Drug Administration’s standard drug approval requirements as long as the providers of those drugs abide by several restrictions, including that they refrain from advertising or promoting particular compounded drugs. Respondents, a group of licensed pharmacies that specialize in compounding drugs, sought to enjoin enforcement of the subsections of the Act dealing with advertising and solicitation, arguing that those provisions violate the First Amendment’s free speech guarantee. The District Court agreed with respondents and granted their motion for summary judgment, holding that the provisions do not meet the test for acceptable government regulation of commercial speech set forth in Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of N. Y., 447 U. S. 557, 566 (1980). The court invalidated the relevant provisions, severing them from the rest of § 127(a).

The Court of Appeals for the Ninth Circuit affirmed in part and reversed in part, agreeing that the provisions regarding advertisement and promotion are unconstitutional but finding them not to be severable from the rest of § 127(a). Petitioners challenged only the Court of Appeals’ constitutional holding in their petition for certiorari, and respondents did not file a cross-petition. We therefore address only the constitutional question, having no occasion to review the Court of Appeals’ severability determination. We conclude, as did the courts below, that §127(a)’s provisions regarding advertisement and promotion amount to unconstitutional restrictions on commercial speech, and we therefore affirm.

I

Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create [361]*361a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product. It is a traditional component of the practice of pharmacy, see J. Thompson, A Practical Guide to Contemporary Pharmacy Practice 11.3 (1998), and is taught as part of the standard curriculum at most pharmacy schools, see American Council on Pharmaceutical Education, Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree, Standard 10(a) (adopted June 14, 1997). Many States specifically regulate compounding practices as part of their regulation of pharmacies. See, e. g., Cal. Code Regs., tit. 16, §§ 1716.2, 1751 (2002); Ind. Admin. Code, tit. 856, §§ 1-30-8, 1-30-18, 1-28-8 (2001); N. H. Code Admin. Rules Ann. Pharmacy, pts. PH 404, PH 702.01 (2002); 22 Tex. Admin. Code §291.36 (2002). Some require all licensed pharmacies to offer compounding services. See, e. g., 49 Pa. Code §27.18(p)(2) (2002); W. Va. Code St. Rules, tit. 15, §19.4 (2002). Pharmacists may provide compounded drugs to patients only upon receipt of a valid prescription from a doctor or other medical practitioner licensed to prescribe medication. See, e.g., Okla. Admin. Code §§535:15-10-3, 535:15-10-9(d) (2001); Colo. State Board of Pharmacy Rule 3.02.10 (2001).

The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), 21 U. S. C. §§ 301-397, regulates drug manufacturing, marketing, and distribution. Section 505(a) of the FDCA, 52 Stat. 1052, as amended, 76 Stat. 784, provides that “[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed [with the Food and Drug Administration] is effective with respect to such drug.” 21 U. S. C. § 355(a). “[N]ew drug” is defined by §201(p)(l) of the FDCA, 52 Stat. 1041, as amended, 76 Stat. 781, as “[a]ny drug . . . not [362]*362generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof.” 21 U. S. C. §321(p). The FDCA invests the Food and Drug Administration (FDA) with the power to enforce its requirements. § 371(a).

For approximately the first 50 years after the enactment of the FDCA, the FDA generally left regulation of compounding to the States. Pharmacists continued to provide patients with compounded drugs without applying for FDA approval of those drugs. The FDA eventually became concerned, however, that some pharmacists were manufacturing and selling drugs under the guise of compounding, thereby avoiding the FDCA’s new drug requirements. In 1992, in response to this concern, the FDA issued a Compliance Policy Guide, which announced that the “FDA may, in the exercise of its enforcement discretion, initiate federal enforcement actions ... when the scope and nature of a pharmacy’s activities raises the kinds of concerns normally associated with a manufacturer and . . . results in significant violations of the new drug, adulteration, or misbranding provisions of the Act.” Compliance Policy Guide 7132.16 (hereinafter Guide), App. to Pet. for Cert. 76a. The Guide explained that the “FDA recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of drugs upon receipt of a valid prescription for an individually identified patient from a licensed practitioner,” and that such activity was not the subject of the Guide. Id., at 71a. The Guide said, however, “that while retail pharmacies ... are exempted from certain requirements of the [FDCA], they are not the subject of any general exemption from the new drug, adulteration, or mis-branding provisions” of the FDCA. Id., at 72a. It stated that the “FDA believes that an increasing number of establishments with retail pharmacy licenses are engaged in [363]*363manufacturing, distributing, and promoting unapproved new drugs for human use in a manner that is clearly outside the bounds of traditional pharmacy practice and that constitute violations of the [FDCA].” Ibid. The Guide expressed concern that drug products “manufactured and distributed in commercial amounts without [the] FDA’s prior approval” could harm the public health. Id., at 73a.

In light of these considerations, the Guide announced that it was FDA policy to permit pharmacists to compound drugs after receipt of a valid prescription for an individual patient or to compound drugs in “very limited quantities” before receipt of a valid prescription if they could document a history of receiving valid prescriptions “generated solely within an established professional practitioner-patient-pharmaey relationship” and if they maintained the prescription on file as required by state law. Id., at 73a-75a.

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Thompson v. Western States Medical Center, 152 L. Ed. 2d 563, 15 Fla. L. Weekly Fed. S 217, 122 S. Ct. 1497, 535 U.S. 357, 70 U.S.L.W. 4275, 2002 U.S. LEXIS 3035, 2002 Daily Journal DAR 4627, 2002 Cal. Daily Op. Serv. 3663 (U.S. 2002).

152 L. Ed. 2d 563 (Thompson v. Western States Medical Center) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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