Facts of the Case

The Food and Drug Administration Modernization Act of 1997 (FDAMA) exempts "compounded drugs," or drugs in which a pharmacist or doctor has combined, mixed, or altered ingredients to create a medication tailored to an individual patient's needs, 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. The restrictions included that the prescription be unsolicited and that the providers not advertise or promote the compounding of any particular drug, class of drug, or type of drug. 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. Agreeing, the District Court held that the provisions constituted unconstitutional restrictions on commercial speech. Affirming in part, the Court of Appeals concluded that the Government had not demonstrated that the restrictions would directly advance its interests or that alternatives less restrictive of speech were unavailable.

Question

Do the prohibitions in the Food and Drug Administration Modernization Act of 1997 with regard to soliciting prescriptions for, and advertising, compounded drugs violate the First Amendment?

Conclusion

Yes. In a 5-4 opinion delivered by Justice Sandra Day O'Connor, the Court held that the FDAMA's provisions amounted to unconstitutional restrictions on commercial speech. Among other findings, the Court reasoned that, although the speech restrictions allegedly served governmental interests in permitting drug compounding while guaranteeing that compounding was not conducted on such a scale as to undermine the drug approval process, it had not been demonstrated that the speech restrictions were not more extensive than necessary to serve such interests. Justice Thomas Clarence filed a concurring opinion. Justice Stephen G. Breyer, joined by Chief Justice William H. Rehnquist and Justices John Paul Stevens and Ruth Bader Ginsburg, filed a dissenting opinion.