While this decision can be viewed as a victory for free speech, the Court’s decision strikes down the entire FDA regulatory scheme governing compounded medicines, including the section that makes it legal to make and sell the mixed drugs. Supreme Court Fills Free Speech Rx for Corner Drugstores

In Thompson v. Western States Medical Center, the Supreme Court has narrowly struck down a federal law that bans pharmacies from advertising "compounded drugs," holding that the ban violates the First Amendment right to free speech.

In a clumsy effort to curtail local pharmacies’ efforts to make and sell compounded medicines on a large-scale basis because the drugs are not subject to the agency’s approval process, the Food and Drug Administration (FDA) prohibited the pharmacies from publicizing and soliciting the compounded wares. The Court’s 5-4 decision, penned by Justice Sandra Day O’Connor, extends commercial speech protection to these types of advertisements and invalidates the FDA’s ban.

The practice of compounding drugs typically involves local pharmacists reformulating medicines or mixing different bulk ingredients to meet the specific needs of their patients. A common example would be a pharmacist heeding Mary Poppin’s "a spoonful of sugar helps the medicine go down" advice by adding bubble gum flavoring to a finicky child’s antibiotic.

The Court’s ruling in this case is another notch in the belt of commercial speech advocates, adding to decisions overturning restrictions on casino and tobacco advertisements, also struck down in the last few years on free speech grounds.

In this opinion, the Justices openly disdain the fact that the government first chose to regulate compound drugs by banning their promotion. "If the First Amendment means anything, it means that regulating speech must be a last — not first — resort. Yet here it seems to have been the first strategy the government thought to try."

The Justices offered suggestions of alternative regulatory solutions, such as limiting the amount of compounded prescriptions an individual pharmacy can make, banning commercial scale manufacturing or requiring warning labels to educate consumers on the fact that the drugs have not undergone the usual testing process needed for FDA approval.

In his dissenting opinion, Justice Breyer is leery of these alternatives as being effective and wary of giving too much protection to commercial speech. "An overly rigid ‘commercial speech’ doctrine will transform what ought to be a legislative or regulatory decision about the best way to protect the health an safety of the American public into a constitutional decision prohibiting the legislature from enacting necessary protections," Justice Breyer wrote.

While this decision can be viewed as a victory for free speech, the Court’s decision strikes down the entire FDA regulatory scheme governing compounded medicines, including the section that makes it legal to make and sell the mixed drugs. Therefore, the ultimate fate of such compounds remains in question.

To read the Court’s opinion, please click here.

May 2, 2001
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