Compounding pharmacies, like the one linked to a deadly outbreak of spinal meningitis this fall, mix up their own drugs with negligible federal oversight. Here’s why
Photograph by Daniel Shea for Bloomberg BusinessweekPaul M. Barrett
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.”
The Skeptic: Pharmacist Sarah Sellers quit compounding over inadequate sterilization and other practices. The influence of anti-aging compounders, she says, “has been surprising and not well understood”
Photograph by Daniel Shea for Bloomberg Businessweek