The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medications continues to draw attention on Capitol Hill and throughout the healthcare system.
The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medications continues to draw attention on Capitol Hill and throughout the healthcare system. Oncologists can't obtain widely-used chemotherapies to treat seriously ill patients. Doctors struggle to provide vital parenteral products for premature babies. Pharmacists have to search for alternate sources of important medications and home-infusion products. Surgeons are postponing operations because key anesthetics and pain medications are not available.
As the drug shortage crisis has made headlines, Congress has expanded investigations into the causes and responses to pharma supply chain difficulties. Some observers charge that too-strict oversight of manufacturing processes by FDA aggravates the problem – while others blame manufacturer negligence and business practices that lead to production errors that put the public health at risk. Some point a finger at government policies that drive down reimbursement for old-line generics, which discourages pharmaceutical industry investment in low-profit therapeutic categories that are difficult to produce.
An FDA public workshop that same month provided a forum for physicians, pharmacists, patient advocates, drug distributors, and manufacturers to air concerns and propose remedies for short-supply situations. Several Congressional committees held hearings last fall on the growing crisis. The outcry prompted the Obama administration to unveil a drug shortages initiative in October 2011, and to issue an executive order for FDA and the Department of Justice to crack down on stockpiling and exorbitant pricing of low-supply drugs. The White House voiced support for legislation that expands advance reporting by manufacturers to FDA regarding production issues likely to lead to shortages.
A main problem is that FDA often does not know about looming drug supply problems because, under current law, only sole-source manufacturers of critical medications have to notify the agency when they anticipate product discontinuation. Some companies voluntarily inform FDA of problems likely to lead to short supplies, but most do not, or act too late.