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Tuesday, October 16, 2012

Compounding Pharmacies

COMPOUNDING PHARMACIES BATTLE REGULATION: Compounding pharmacies have been suddenly thrust into the public spotlight after multiple cases of meningitis were traced to steroids mixed -- or compounded -- at a pharmacy in Massachusetts. Compounding pharmacies, which operate differently than regular pharmacies, are a relatively new phenomenon, and the battle over how they're regulated is still being fought.

But the young industry has isn't naive in the ways of Washington. The Wall Street Journal reported yesterday, citing Center for Responsive Politics data, that the International Association of Compound Pharmacies has spent more than $1.1 million since 2000, wrangling with Congress and regulators at the Food and Drug Administration.

As the Journal points out, it's not clear that the current meningitis outbreak would have been prevented by any proposed regulations (or better oversight of current regulations), but a review of lobbying records on shows that the IACP isn't the only group lobbying on compounding pharmacies. In fact at least 30 organizations have filed dozens of lobbying reports in the last decade on the issue of "compounding" -- many of them individual compounding pharmacies, but also a number of pharmaceutical giants with high-octane lobbying operations, like Wyeth, AstraZeneca and Pfizer.
From the Wall Street Journal report:
After regulators including Dr. [David] Kessler called for greater oversight of the industry, Congress in 1997 passed a law that gave the FDA clearer authority to treat them like drug makers. Small pharmacies were exempt from FDA regulation, but those that advertised or solicited business faced greater FDA scrutiny.
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.
When Edward Kennedy and Pat Roberts were working on a new law in 2007, compounding pharmacies mobilized their clients. Reuters reports:
Compounders also enlisted parents of autistic children, who besieged Kennedy's office, arguing that compounding pharmacies were the sole source of treatments for the condition, such as the unproven therapy chelation to remove toxic metals from the body. Kennedy's bill never reached the floor.
The bill's proponents "saw the opposition and decided it wasn't going anywhere," said Fusco Walker.