Shalala

This appeal requires us to assess the constitutionality of two subsections of the Food and Drug Administration Modernization Act of 1997 (“FDAMA”), 21 U.S.C. § 353a. Subsections §§ 353a(a) and (c) of FDAMA prohibit drug providers from promoting or advertising particular compounded drugs. In return, the providers are exempted from the standard drug approval requirements imposed by the Food and Drug Administration. Plaintiffs seek to enjoin the enforcement of these subsections, contending that they violate the First Amendment’s guarantee of free speech. The district court agreed with Plaintiffs and granted their motion for summary judgment in a published opinion. See Western States Medical Ctr. v. Shalala, 69 F.Supp.2d 1288 (D.Nev.1999). The district court exercised jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1361. We have jurisdiction over this appeal pursuant to 28 U.S.C. § 1291 .

I

Plaintiffs are a group of licensed pharmacies. They have prepared written promotional materials that they distribute by mail and at medical conferences to inform patients and physicians of the uses and effectiveness of specific compounded drugs. “Compounding” is a process in which a pharmacist…