No.01-344.Argued February26, 2002—Decided April 29, 2002
NATURE OF CASE: Review of the restrictions on commercial free speech in relation to the advertisement of specified compounded drugs.
PROCEDURAL HISTORY: Section 503A of the Food, Drug and Cosmetic Act, 21 U.S.C. § 353a exempts compounded drugs from certain provisions of the Food and Drug Administration’s standard approval requirements; provided that the distributors abide by certain restrictions, including advertising and promoting selected compounded drugs. The Act, however, did not prohibit the advertising of its effectiveness. The Central Hudson Gas et. Elec. Corp v. Public Serv. Comm’n of NY, 447 U.S. 557, 566 held that the restrictions directly advance its interests, or that less restrictive alternatives were unavailable.
ISSUE : Whether a federal law that bans the advertising or promoting of particular drug compounds but permits advertising their effectiveness undermines freedom of speech as outlined in the First Amendment.
FACTS: Pharmacists sometimes alter the physical form of a drug, or combine various drugs with a technique known as compounding. The process is used to meet the specific needs of a particular patient. The FDA and Modernization Act of 1997 prohibited such pharmacies from promoting and advertising these compounded drugs. The Act, however, did not prohibit them from advertising the effectiveness of the drugs. Western States Medical Center was one of these groups, which advertised effectiveness via the mail and medical conferences. The group filed suit in Federal Court to enjoin the enforcement of the advertising prohibitions as a violation of the first amendment-commercial free speech.
RULE OF LAW: Commercial free speech warrants constitutional protection only when it enables consumers to make “intelligent and well informed decisions.” Deceptive or misleading information subverts that value