Pharmaceutical Compounding Problems Spread Under Lax Regulation
News outlets report that congressional oversight was lacking and the Boston Globe uncovers documents about the company that started the meningitis outbreak.
The New York Times: Friends In Congress Have Helped Drug Compounders Avoid Tighter Rules
[B]y positioning itself as a more affordable, community-based alternative to huge drug manufacturers, compounders have attracted broad support from politicians. They have become popular among proponents of hormone therapy to slow aging and advocates for the autistic, who often distrust the traditional pharmaceutical industry, and rely on compounders’ tailor-made blends (Lichtblau and Tavernise, 11/13).
The Boston Globe: State Was Lax On Framingham Drug Maker
State pharmacy regulators on at least two occasions in the past decade displayed indifference in their oversight of a troubled Framingham specialty pharmacy that has now been blamed for a national fungal meningitis outbreak, according to documents obtained by the Globe Tuesday. At the same time state and federal regulators were investigating New England Compounding Center for problems with sterile drug preparation, the company’s lead pharmacist, Barry Cadden, was chosen to serve on a state pharmacy board task force to write new rules for compounding pharmacies (Lazar and Kowalczyk, 11/14).
USA Today: FDA Finds Contamination Issues At Ameridose
Federal drug inspectors found a range of problems, including ineffective drugs given to children and pregnant women, leaky ceilings, insects, non-sterile conditions and at least one bird flying around, at a sister company to the Massachusetts compounding pharmacy linked to a national outbreak of fungal meningitis (Weise, 11/13).