Thompson v. Western States
(US Supreme Court, Slip Op No. 01-344, 535 US___, 2002)

Briefed by Anna Longwell, Esq., 2002

Summary

The Supreme Court applies the Central Hudson test to a provision in the Food, Drug and Cosmetic Act (§503A) prohibiting a pharmacist offering compounding services to advertise or to solicit business for specific drugs. The Court finds (6/3) that the provision is an unconstitutional restriction on commercial speech, and is therefore struck down. The restriction may be seen to advance a substantial government interest. However, the Court found that FDA had failed to show that no alternatives to speech restriction were available to advance this interest. Thus the restriction failed the last element of the Central Hudson test.

History

Pharmacy compounding is the re-formulation of commercially available drugs to make special dosage forms for specific patients, e.g., to provide liquid dosage forms for people unable to swallow pills. It is done by registered pharmacists under a doctor’s prescription, and is legal in all 50 States. FDCA regulates all drug manufacturing, and if compounding were done on a sufficiently large scale, it could be manufacturing and marketing a new drug product, that is, a formulation that had not been tested and found by FDA to be safe and effective under a New Drug Application (NDA). By 1992, FDA expressed concern that the volume and the national marketing scope of some compounding pharmacies were turning them into drug manufacturers. Congress responded to this concern in 1997. (21 USC§ 353a) The law provided conditions under which pharmacists could compound without a NDA. There were six conditions for exemption. The first five provisions of the law restricted the practice of compounding to compounds and ingredients known by FDA to be safe and not difficult to compound. They also restricted the amount of interstate volume for compounded drugs, and limited the inventory of compounded products to an amount that could be justified by past prescription ordering history. The law also forbids the advertising of compounding “any particular drug, class of drug, or type of drug” although the service of compounding may be advertised. This last restriction caused the lawsuit by a compounding pharmacy. Western sued FDA in District Court in Nevada, alleging that this restriction was an unconstitutional restraint on speech. DC found the restriction unconstitutional, but enjoined only the speech-regulating sections of §353a. FDA appealed, claiming that the sections of 335a were not severable, and that the restrictions were not unconstitutional. The Ninth Circuit agreed that the sections were not severable, but continued to hold the restrictions unconstitutional, finding that the government had failed to show either that the restrictions would directly advance a substantial government interest or that alternatives less restrictive of speech were not available. Ninth Circuit invalidated §353a in its entirety. FDA appealed further on the issue of constitutionality, SC granted cert. FDA argued that the restriction was necessary to protect FDAs interest in preserving the new drug approval system, while permitting pharmacy compounding to continue. D’s argued that there were a number of ways to advance these interests without restricting advertising.

Findings

SC applied the Central Hudson test and found:

  1. The advertising was for a lawful activity, and was truthful and not misleading. Therefore the First Amendment protected it.
  2. The government had demonstrated a substantial interest that was advanced by the restriction
  3. The government had failed to prove that the law was the least restrictive means of advancing the substantial government interest. Therefore the law was invalidated.

Results

SC seems to set a fairly high burden of proof to pass the last element of the Hudson test, as they were convinced by Ds examples of alternatives. However, now all of 21 USC 353a is invalid, as the 9th Cir. holding that the law was not separable was not challenged. Essentially, the situation is back to the pre-1997 status.