Drug Shortages Create Crisis for Manufacturers, Regulators

Clamor mounts over compromised care and rising costs due to lack of crucial therapies.
Nov 02, 2011
Volume 35, Issue 11

Jill Wechsler
The outcry from physicians, pharmacists, and patients over disruptions in the supply of vital medicines to treat cancer, pain, and other serious conditions is drawing attention on Capitol Hill and throughout the healthcare system. Oncologists cannot obtain widely-used chemotherapies to treat seriously ill patients. Surgeons are postponing operations because they lack key anesthetics and pain medications. Doctors are struggling to obtain vital parenterals for premature babies and for patients requiring infusion. And dozens of clinical trials have been halted because investigators don't have adequate supplies of cancer drugs used as components of treatment arms or as controls.

Raising prices?
While there always have been periodic drug shortages, the problem has become much more acute in the past two years. The main culprit appears to be drug manufacturing and supply-chain failings, particularly related to the production of generic sterile injectables. Decisions by firms to exit certain low-profit markets often leave only one or two producers for a widely-used parenteral or other product. Some manufacturers have had to halt production due to problems meeting GMPs. Such developments raise charges that too-strict FDA oversight aggravates the problem—or that industry negligence and business practices put the public health at risk. Another possibility is that policies and practices that drive down reimbursement for old-line generics discourages industry investment in certain therapeutic categories (see sidebar, "Raising prices").

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.

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