OCTOBER TERM, 2001
Syllabus
MEDICAL CENTER et al.
certiorari to the united states court of appeals for the ninth circuit
No. 01-344. Argued February 26, 2002—Decided April 29, 2002
Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to an individual patient's needs. The Food and Drug Administration Modernization Act of 1997 (FDAMA) exempts "compounded drugs" from the Food and Drug Administration's (FDA) standard drug approval requirements under the Federal Food, Drug, and Cosmetic Act (FDCA), so long as the providers of the compounded drugs abide by several restrictions, including that the prescription be "unsolicited," 21 U. S. C. § 353a(a), and that the providers "not advertise or promote the compounding of any particular drug, class of drug, or type of drug," § 353a(c). Respondents, a group of licensed pharmacies that specialize in compounding drugs, sought to enjoin enforcement of the advertising and solicitation provisions, arguing that they violate the First Amendment's free speech guarantee. The District Court agreed and granted respondents summary judgment, holding that the provisions constitute unconstitutional restrictions on commercial speech under Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N. Y., 447 U. S. 557, 566. Affirming in relevant part, the Ninth Circuit held that the restrictions in question fail Central Hudson's test because the Government had not demonstrated that the restrictions would directly advance its interests or that alternatives less restrictive of speech were unavailable.
Held: The FDAMA's prohibitions on soliciting prescriptions for, and advertising, compounded drugs amount to unconstitutional restrictions on commercial speech. Pp. 366-377.
(a) For a commercial speech regulation to be constitutionally permissible under the Central Hudson test, the speech in question must concern lawful activity and not be misleading, the asserted governmental interest to be served by the regulation must be substantial, and the regulation must "directly advanc[e]" the governmental interest and "not [be] more extensive than is necessary to serve that interest," 447 U. S., at 566. Pp. 366-368.
(b) The Government asserts that three substantial interests underlie the FDAMA: (1) preserving the effectiveness and integrity of the
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