By Paul M. Barrett on November 14, 2012
In October 2003, the Senate Committee on Health, Education, Labor, and Pensions assembled for hearings on compounding pharmacies. These state-licensed retail businesses mix and sell medications, but without the federal safety approval required for mass-produced drugs. Then-Senator Christopher Bond (R-Mo.) convened the hearing by warning of “a significant number of very real problems caused by compounded drugs.” The committee, he said, had “received reports of non-sterile eye drops causing blindness; spinal injections contaminated with bacteria and/or fungus, resulting in hospitalizations and, in some cases, death; and children poisoned as a result of pharmacy compounding errors.” In one case, a pharmacist in Bond’s home state had been convicted in 2002 and sent to prison for diluting more than 4,000 doses of chemotherapy drugs.
Expert witnesses testified that to address such dangers, Congress should give the Food and Drug Administration authority over compounders. Not everyone agreed. Senator Pat Roberts (R-Kan.) commented from the dais that he’d met privately with a physician named Steven Hotze, who was “eager to provide the committee with his input on this important topic.” That input bore the stamp of Hotze’s free-market philosophy. “Regulatory agencies,” he asserted in written testimony, “cannot prevent an individual from committing a criminal act. However, regulatory agencies can, and often do, adversely affect the efficient, safe, and productive practice of business.”
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