378
Breyer, J., dissenting
Justice Breyer, with whom The Chief Justice, Justice Stevens, and Justice Ginsburg join, dissenting.
Federal law requires strict safety and efficacy testing of all "new" prescription "drugs." 21 U. S. C. § 355. See 21 CFR § 310.3(h) (2002) (defining "new drug" broadly). This testing process requires for every "new drug" a preclinical investigation and three separate clinical tests, including small, controlled studies of healthy and diseased humans as well as scientific double-blind studies designed to identify any possible health risk or side effect associated with the new drug. Practical Guide to Food and Drug Law and Regulation 95-102 (K. Piña & W. Pines eds. 1998). The objective of this elaborate and time-consuming regulatory regime is to identify those health risks—both large and small—that a doctor or pharmacist might not otherwise notice.
At the same time, the law exempts from its testing requirements prescription drugs produced through "com-pounding"—a process "by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient." Ante, at 360-361. The exemption is available, however, only if the pharmacist meets certain specified conditions, including the condition that the pharmacist not "advertise or promote the compounding of any particular drug." 21 U. S. C. § 353a(c) (emphasis added).
The Court holds that this condition restricts "commercial speech" in violation of the First Amendment. See Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N. Y., 447 U. S. 557, 564 (1980). It concedes that the statutory provision tries to "[p]reserv[e] the effectiveness and integrity of the . . . new drug approval process," ante, at 369, and it assumes without deciding that the statute might " 'directly advance' " that interest, ante, at 371. It nonetheless finds the statute unconstitutional because it could advance that interest in other, less restrictive ways. Ante, at 372-373. I disagree with this conclusion, and I believe that the Court
Page: Index Previous 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 NextLast modified: October 4, 2007