Delegates back mandatory drug shortage notification system
■ The move came as Congress was agreeing on legislation mandating warnings if shortages occur.
By Victoria Stagg Elliott — Posted July 2, 2012
Chicago Pharmaceutical manufacturers should be required to alert the Food and Drug Administration about potential drug supply shortfalls at least six months in advance or as soon as a problem is known, according to a report adopted at the American Medical Association Annual Meeting in June. Delegates said being unable to get crucial drugs because of ongoing and recurring shortages was thwarting good patient care.
“Drug shortages are a national crisis, and a national shame,” said Charles Moss, MD, a Hackensack, N.J., vascular surgeon and a delegate speaking for the Medical Society of New Jersey.
The AMA Annual Meeting was occurring as lawmakers announced a June 18 agreement on provisions establishing a mandatory shortage reporting system. The language was included in legislation reauthorizing the Prescription Drug User Fee Act subsequently approved by Congress and sent to the White House for President Obama’s signature.
More than 225 drugs are listed in short supply by the American Society of Health-System Pharmacists. To address the problem, Obama signed an executive order on Oct. 31, 2011, instructing the FDA to set up a voluntary advance warning system for potential shortages and speed the review of applications from companies looking to ramp up or change production in response to supply problems. The AMA report, which was written by the AMA Council on Science and Public Health, states that this system should not be optional.
“Drug shortages are affecting our best practices, and we consider it a patient safety issue,” said Alvin C. Head, MD, a delegate from Augusta, Ga., speaking on behalf of the American Society of Anesthesiologists.
The AMA also adopted policy advocating that the FDA or Congress require manufacturers to establish plans for supply continuity to avoid production shortages whenever possible. In addition, the Association supports the creation of an interagency task force to improve the ability of the Dept. of Health and Human Services to respond to drug supply problems.