Supreme Court ruling bares history of FDA action

WASHINGTON-As the U.S. Food and Drug Administration's (FDA) labors to restrict compounded drugs for nonfood animals, its efforts are preceded by a 2002 supreme court case in which justices criticized the agency for restricting pharmacists' free speech rights.

In Thompson vs. Western States Medical Center, the high court's decision upheld an appellate court ruling that struck down FDA restrictions on the advertising of drug compounding products and services. In their findings, justices deemed section 503A of the Food and Drug Administration Modernization Act of 1997 (FDAMA) unconstitutional. The law, written to amend the Federal Food, Drug and Cosmetics Act of 1938, exempted compounded drugs from FDA drug approval requirements as long as the makers abided by several restrictions, including refraining from promotion and advertising certain drugs, court records show.

Attorney Howard Hoffmann, who represented Western States Medical Center, says its a landmark decision.

"This is the definitive case on compounding," he says. "When I think of FDA on issues like this, the word schizophrenia or biopolar comes to mind. On one hand, they recognize the importance of compounding; on the other, they want to control and stop it."

Motive to restrict

FDA argued that the drug approval requirements were critical to public health and safety. But while the government praised FDAMA restrictions, it acknowledged that eliminating the practice of compounding drugs for individual patients would be undesirable, as it's sometimes critical to the care of patients.

Meanwhile advertising, FDA noted, is not typically associated with compounding for individuals, but in contrast, "a fair proxy for actual or intended large-scale manufacturing," records show. The restriction also closed "a loophole that would allow unregulated drug manufacturing to occur under the guise of pharmacy compounding," FDA says.

Illegal limits

The court, in turn, ruled that several non-speech-related means of drawing a line between compounding and large-scale manufacturing exist without violating the First Amendment. In its opinion, justices note that even if the government's concern was that advertising compounders' services would create a public risk by motivating patients who do not need drugs to request them, that doesn't justify free speech restrictions as the dispense of compounded drugs requires a prescription.

The court chastised the government for not pursuing alternative options before restricting free speech.

"If the First Amendment means anything, the majority wrote, "it means that regulating speech must be the last - not the first - resort. Yet this seems to have been the first strategy the government thought to try."