Senators Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) have introduced a bill that has been called an important first step to resolving the drug shortage crisis. The Preserving Access to Life-Saving Medications Act (SB 296) requires prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage. “Last year the FDA actually averted over 30 drug shortages when they had advance communication about them,” Vaida said. “If they know beforehand, the FDA can work with manufacturers on quality issues, fast track inspections and work with other manufacturers to see if they can take up some of the slack.”
Explore This IssueMay 2011
But that’s only one step, he added. ASHP, which hosted a summit meeting on the drug shortage in November 2010, has taken the lead in bringing together groups of physicians, pharmacists and others involved in the issue, including manufacturers, group purchasing organizations, third-party payers and professional societies such as ASA and ASCO (because chemotherapy and anesthesia drugs have been among the hardest hit).
“They’re working on supply and raw materials, regulatory issues and distribution issues, hoping to address some of the other factors that lead to shortages,” Vaida said. “But in the meantime, a lot of the unpredictability is still going on. We don’t know what will be short when. Nobody has a good handle on what is going to hit next.”