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."
Today, Dr. Kessler, who worked for Republican and Democratic administrations, seems eerily prophetic. A painkilling steroid from the New England Compounding Center has exposed as many as 14,000 patients to fungal meningitis, sickened 203 people and killed 15 people. The center has shut down, and health officials warn that the number of cases is expected to rise.
How these firms escaped closer regulation shows how little happens in Washington absent an emergency. Top lawmakers and federal officials tried for years to increase regulation. A countereffort by the industry and a series of court decisions helped beat that back. Federal agencies debated about who should crack down on the industry. Lawmakers eventually abandoned their push after deciding the issue wasn't important enough.
From 2001 to this year, the International Academy of Compounding Pharmacists spent about $1.1 million on lobbying, according to disclosure reports filed with Congress. In a newsletter to members, the academy described how it defeated a 2007 bipartisan draft bill that would have given the FDA more authority to regulate compounding pharmacies after hundreds of its pharmacists canvassed Capitol Hill urging lawmakers to abandon the proposed legislation.
It isn't known whether tighter regulations would have stopped the outbreak tied to the New England Compounding Center. Lawmakers in that 2007 bill proposed restricting distribution of compounded drugs across state lines, which could have prevented the steroid injections from reaching clinics in 23 states. They also proposed giving the FDA more power to inspect facilities.
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