Drug-mixing ad rules to get high court test

Tuesday, October 30, 2001

Since colonial days, American pharmacists have been mixing their own medicines to fit the medical needs of individual customers.

Even today, in spite of heavy regulation of the pharmaceutical industry, pharmacists are still permitted to do their own compounding, as the practice is called — but under severe restrictions.

Yesterday, the Supreme Court agreed to review a case in which one aspect of those restrictions was challenged on First Amendment grounds. The case of Thompson v. Western States Medical Center, which is to be argued early next year, will be the court’s next in a series of commercial-speech cases.

At issue is a law passed by Congress in 1997 that imposed several restrictions on pharmacies that still mix their own medications. Congress recognized the value of compounding for patients who, for example, might be allergic to one ingredient in a commercial product, or who might need diluted doses. But Congress responded to the concerns of the Food and Drug Administration that pharmacies, under the guise of compounding, would mass-produce medications that would escape the regulations governing the introduction of new medicines on the market.

Under the new law, pharmacists can produce compounds in limited amounts only for specific patients, avoiding drugs that have been taken off the market. The law also prohibits pharmacies from soliciting patients and says they may not “advertise or promote the compounding of any particular drug.” They can advertise the fact that they compound drugs in general, but may not advertise a specific drug they make.

Eight pharmacies that specialize in compounding challenged the advertising and promotion restriction as a violation of their free-speech rights under the First Amendment. Both a district court and the 9th U.S. Circuit Court of Appeals agreed with the pharmacists.

Employing the classic test for commercial speech from the Supreme Court’s 1980 ruling in Central Hudson Gas & Electric Corp. v. Public Service Commission, the appeals court struck down the 1997 law. While agreeing with the government that it has a substantial interest in “preserving the integrity of the drug approval process,” the appeals panel concluded that the solicitation and advertising restrictions do not directly advance that interest and are more extensive than necessary.

The 9th Circuit’s ruling in the case last February prompted an appeal from the Bush administration. Solicitor General Theodore Olson told the justices in a brief that allowing the ruling to stand would “strike at the core of the drug approval requirements.” The restrictions at issue are necessary, Olson argued, because advertising and promotion are earmarks of a pharmacy that is more interested in mass production than individual compounding.

The outcome of the case is difficult to predict. The justices are increasingly inclined to protect commercial speech or advertising, and they have struck down several laws that restrict truthful advertising as a way of limiting the underlying business. On the other hand, rulings from the often liberal 9th Circuit are frequently overturned, and the regulation of potentially harmful drugs may in this case outweigh the high court’s usual First Amendment sympathies.