LINDA GREENHOUSE
Reading about the belated scramble by Massachusetts regulators toinspect the compounding pharmacies in their state in the wake of the meningitis crisis left me wondering about the apparent lack of federal oversight of the $3 billion
compounding pharmacy industry. And that thought in turn called to mind an obscure Supreme Court decision from a decade ago that invoked the First Amendment to block one avenue of attempted federal regulation.
compounding pharmacy industry. And that thought in turn called to mind an obscure Supreme Court decision from a decade ago that invoked the First Amendment to block one avenue of attempted federal regulation.
In that 2002 decision, Thompson v. Western States Medical Center, the court held by a vote of 5 to 4 that a congressional restriction on advertising by compounding pharmacies violated the companies’ right to free speech. The advertising restriction was part of a bargain that Congress made with the industry in a 1997 law, the Food and Drug Administration Modernization Act. Under this deal, compounded drugs — those specially formulated to meet the needs of patients not served by drugs generally available on the commercial market — would not have to go through the Food and Drug Administration’s approval process as long as the pharmacies that made them abided by certain rules.
One of the rules concerned soliciting business through advertising. A pharmacy could advertise its general availability for compounding, but could not “advertise or promote the compounding of any particular drug, class of drug, or type of drug.” The idea, as the government later explained to the Supreme Court, was that compounding pharmacies could continue to serve their traditional role of filling doctors’ prescriptions for individual patients, but would be limited in their ability to solicit business on a big scale or to engage in large-scale drug production — in other words, to conduct the kind of multi-state business in which the New England Compounding Pharmacy was engaged before it was shut down in the wake of the meningitis cases tied to its tainted product.
One of the rules concerned soliciting business through advertising. A pharmacy could advertise its general availability for compounding, but could not “advertise or promote the compounding of any particular drug, class of drug, or type of drug.” The idea, as the government later explained to the Supreme Court, was that compounding pharmacies could continue to serve their traditional role of filling doctors’ prescriptions for individual patients, but would be limited in their ability to solicit business on a big scale or to engage in large-scale drug production — in other words, to conduct the kind of multi-state business in which the New England Compounding Pharmacy was engaged before it was shut down in the wake of the meningitis cases tied to its tainted product.
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