U.S. Supreme Court Hears Case Related to Pharmacy Compounding
This case emerged from a ruling by the United States Court of Appeals for the 9th Circuit, which held that the restriction on advertising to be an unconstitutional violation of free speech and further noted that the provision could not be severed from the rest of the compounding language included in FDAMA. FDAMA, when enacted in 1997, simply clarified FDAs position on compounding and enumerated the instances when compounded products were not to be considered new drugs. The 9th Circuits decision invalidated FDAMAs compounding provisions, thereby resulting in substantial confusion about the practice of compounding. (For more details on the 9th Circuits ruling, see the March 2001 Federal Legislative Issues Summary.)
In the appeal to the Supreme Court, the United States Department of Justice (DOJ), on behalf of FDA and the federal government, waived the severability issue, noting that the advertising provision is an integral part of the FDAMA provision on compounding. Thus, if the Supreme Court finds the advertising provision to be unconstitutional, the entire compounding section of FDAMA will fail.
DOJ, in defending the constitutionality of the limitations on speech relating to pharmacy compounding, ventures into new ground. In its Supreme Court brief, DOJ asserts that the "introduction of compounded new drugs into interstate commerce" was unlawful in all circumstances before FDAMAs enactment in 1997. Thus, DOJ asserts that compounded products will be illegal (or subject to the new-drug approval process) if FDAMA is not upheld.
If compounded drugs were to be subjected to the requirements of new drugs, this would have an extremely detrimental effect on patients as well as the practice of pharmacy. As a result, several pharmacy groups filed amicus (or "friends of the court") briefs opposing the assertion that, up until the enactment of FDAMA, compounds that did not undergo the new-drug approval process were in violation of the Food, Drug, and Cosmetic Act.
ASHP, which has a strong interest in preserving pharmacists right to compound drug products needed to meet patients needs, considered filing a brief. However, it is important to note that the legality of compounding is not the issue before the Supreme Court. Instead, the court will address the more narrow issue of whether the advertising provision is unconstitutional. The issue raised regarding the legality of pharmacy compounding before the enactment of FDAMA is outside the scope of the courts review. For these reasons, and with the concurrence of outside counsel, ASHP decided not to file an amicus brief.
The Supreme Court is expected to render a decision on the First Amendment issue before adjourning this fall. FDAMA, as it stands now, recognizes the value of pharmacy compounding and creates an important safe harbor for compounders. If the court invalidates FDAMAs compounding provisions, the regulation of compounded drug products may be called into question. If this happens, ASHP will defend this important aspect of pharmacy practice.