WALTHAM — Wielding a glass mortar and pestle, pharmacy intern Joanne Lee mixes liquid medication used to treat parasites. It’s grape-flavored, to appeal to a child’s palate. At a nearby work station, a worker clad in gloves, mask, lab coat, boots, and hairnet weighs powder under a protective hood. Other technicians at Johnson Compounding & Wellness Center prepare hormone cream, produce vitamins, and heat a viscous gel to make a customized suppository.
The pristine, brightly lighted laboratory, visible behind a wall of windows at the back of the store, provides a glimpse of a niche area of drug preparation that has been abruptly thrust into the spotlight. A widening outbreak of fungal meningitis linked to steroids made by a Framingham compounding pharmacy has focused scrutiny on the regulation of such businesses. But much about how compounding pharmacies function, and even what compounding really is, has remained obscure.
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How come this story doesn't raise the issue of which Massachusetts senatorial candidate the Johnson Compounding & Wellness Center may have given to or at least considered so doing? The Boston Globe tried to hang an albatross of campaign donations from the New England Compounding Center - the pharmacy reputedly dead center in the midst of a continually spreading meningitis epidemic that has reportedly killed more than a dozen people so far - around the campaign neck of U.S. Sen. Scott Brown. This reader has to wonder why the Johnson firm was gracious enough to allow Globe reporters into its premises, and if there continues to be a wonder what the Boston Globe might do to its reputation because it belongs to a certain industry.
Per today's Wall Street Journal, "In 1996, David Kessler, then the commissioner of the Food and Drug Administration, warned Congress that tiny drug-compounding pharmacies would spawn a "shadow industry" of unapproved drugs that "could result in serious adverse effects, including death."
"In 2001-02, four people died, more than a dozen were injured and hundreds exposed after they received back-pain shots tainted with meningitis dispensed by two pharmacies in California and South Carolina. The pharmacist in charge at the California facility later surrendered his license after state regulators found nonsterile conditions."
"Around that time, seven compounding pharmacies filed a lawsuit seeking to peel back the FDA's regulatory powers on the grounds that the provision on advertising violated the First Amendment. In 2002, the Supreme Court struck down the 1997 law in a 5-4 ruling that found the law was an unconstitutional prohibition against commercial free speech."
"After that, the FDA tried to regulate the industry by issuing compliance policy guidelines. But those had little effect, attorneys say, because they don't carry the same weight as laws or formal regulations."
More from today's Wall Street Journal, "There was a very strong legal effort and political campaign on the part of the compounders not only to influence the legislation but make sure it never saw the light of day," said Ms. Sellers, who now consults for drug makers."
"Mr. Miller of the IACP said the compounding pharmacy group fought past legislation because it would have allowed the FDA to duplicate regulation assigned to states. "
"Our association feels firmly that constitutionally, regulation is assigned to state boards of pharmacy," he said.
"In 2009, a compounder in Ocala, Fla., accidentally caused the death of 21 ponies of the Venezuelan national polo team with high doses of a dietary supplement. Florida's pharmacy board issued a fine to Franck's Lab Inc. and reprimanded it."
"The FDA inspected the lab three times in 2009 and sought a court injunction to stop it from further compounding animal medicines. Last year a federal district judge rejected the FDA's request, saying that existing law didn't give the agency such power over compounding pharmacies."
Only continuous monitoring and frequent inspection by an enforcement agency is going to prevent contamination, which can develop in a moment. A three-year inspection cycle by a trade group with no enforcement power is completely ineffective. Massachusetts has never operated a program of continuous monitoring and frequent inspection, and it is currently completely unprepared to do so.