These issues made headlines in September as Congressional committees held hearings on the drug shortage crisis and broader pharmaceutical supply-chain problems. An FDA public workshop on Sept. 26, 2011, provided a forum for health professionals, patient advocates, drug distributors and manufacturers to air concerns and propose remedies for short drug supplies. The resulting publicity has boosted Congressional interest in legislation to address pharmaceutical supply-chain issues in general, and the drug shortage situation in particular. FDA has prepared a report analyzing steps it can take to tackle shortages with its current limited authority, and the Government Accountability Office (GAO) is examining the causes and responses to the drug shortage crisis.Getting worse
Policymakers may take action because, despite extensive FDA efforts, "drug shortages are getting worse," said Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research (CDER), at the FDA workshop. The agency recorded 178 drug shortages in the US in 2010, up from 157 in 2009—and much more than the 50–60 per-year range of previous years, reported Edward Cox, coordinator of CDER's drug-shortage program. The problem is even more serious when looking at all drugs and biologics: the University of Utah Drug Information Service recorded 210 shortages this year as of mid-September, slated to surpass last year's total 211 short-supply problems. And because supply problems often last more than a year, some 260 active shortages are in the Utah tracking system.
Moreover, 74% of the shortages reported to FDA last year involved sterile injectables—and almost all of them for "medically necessary" drugs, noted Howard Koh, assistant secretary for health in the US Department of Health and Human Services (HHS), at a September hearing before the House Energy and Commerce Health subcommittee.
Shortages in parenterals have taken a toll on hospitals and clinics: a survey by the American Hospital Association in June 2011, found that virtually all hospitals have experienced at least one drug shortage this year, and half report 21 or more supply problems. This builds on a March survey by the Premiere Healthcare Alliance that documented soaring shortages along with exorbitant prices for these products (see the June 2011 Washington Report column, "Safety Concerns and Shortages Challenge Manufacturers").
Koh cited a long list of underlying factors driving the short-supply trend: industry consolidation, limited raw materials, changes to inventory and distribution practices, production delays, increases in demand, and business d decisions to close down a manufacturing site. When there are only one or two sources for a crucial drug, explained pharmacist Richard Paoletti of Lancaster (Pennsylvania) General Health, a small shift in production lines, plus just-in-time inventory controls at hospitals, make it hard to buffer the impact.