January 27, 2012
Senators Klobuchar & Collins Address Drug Shortages Crisis on Senate Floor
Yesterday Senator Amy Klobuchar (D-MN) and Senator Susan Collins (R-ME) offered remarks to colleagues on the Senate floor regarding the drug shortages crisis. Additionally, as the sponsor of S. 296, the “Preserving Access to Life-Saving Medications Act,” Senator Klobuchar welcomed Senator Collins as the 22nd co-sponsor of the bill.
Their remarks imparted the continuing need for solutions to the drug shortage crisis by sharing personal stories and noting information presented to them by physicians and the broader medical community.
ASA continues to support S. 296 and other efforts to combat the drug shortages crisis.
Excerpts of the senator’s comments are below.
Senator Klobuchar excerpt:
“This is a crisis that has grown to such proportion that current drug shortages have impacted individuals all across the country, forcing some patients to delay their lifesaving treatments or use unproven, less effective alternatives. In some cases, drug shortages have even resulted in patient deaths."
"Last year, I introduced the Preserving Access to Life-Saving Medications Act to address this issue….This bipartisan bill would require drug manufacturers to provide early notification to the FDA whenever there is a factor that may lead to a shortage. This will help the FDA take the lead in working with pharmacy groups, drug manufacturers and health care providers to better manage and prepare for impending shortages, more effectively manage those shortages when they occur, and minimize--and that is what we want to do--their impact on patient care. The legislation would also direct the FDA to provide up-to-date public information of a shortage situation and the actions the agency would take to address them."
"Additionally, the bill requires the FDA to develop an evidence-based list of drugs vulnerable to shortages and to work with the manufacturers to come up with a continuity of operations plan to address potential problems that may result in a shortage. The bill would also direct the FDA to establish an expedited reinspection process for manufacturers of a product in shortage. With manufacturers providing early notification, the FDA's drug shortage team--and they do now have a drug shortage team--can then appropriately use their tools to prevent shortages from happening."
Senator Collins excerpt:
"Many of the drugs in short supply are vital. They are used in hospitals and cancer centers for anesthesia, for chemotherapy and for the treatment of infections. There are also continuing shortages of drugs used in emergency rooms and in intensive care units."
"I have met with several doctors and other medical professionals and pharmacists in Maine who are extremely concerned about this issue. They have told me that these shortages are causing serious problems around our State and across our nation, including forcing some medical centers to ration drugs or postpone elective surgeries."