Washington, D.C. – U.S. Senator Amy Klobuchar today called on her colleagues to swiftly pass legislation to prevent critical drug shortages. Legislation that is being considered in the Senate this week includes Klobuchar’s bipartisan early warning provision to give the FDA the tools it need to stop shortages before they occur. During a speech on the floor of the U.S. Senate, Klobuchar highlighted stories of Minnesotans who have been affected by drug shortages and said the problem was too urgent to delay taking action.
“Patients shouldn’t have to be burdened with the added stress and worry about whether or not they will have enough medicine to treat their disease tomorrow. Their attention and energy should be focused on getting better and living healthy, productive lives,”Klobuchar said. “I urge my colleagues to take action and pass this legislation to help prevent future shortages from wreaking havoc on families’ lives.”
The Food and Drug Administration Safety and Innovation Act includes the bipartisan drug shortages agreement Klobuchar helped forge that would require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage. This is the key provision in the Preserving Access to Life-Saving Medications Act, legislation Klobuchar introduced with Sen. Bob Casey (D-PA) and cosponsored by Senator Susan Collins (R-ME) and 28 other senators. The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from companies, up from 38 in 2010. During a recent FDA workshop, FDA officials said that the rise in preventions is due to increased pressure from Klobuchar and other members of Congress.
The agreement also includes two other provisions similar to Klobuchar’s legislation: it would direct the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage, and require the FDA to keep detailed records of previous drug shortages and the actions taken to prevent them. It would also establish a task force to create a strategic plan to improve communication within the FDA and with public stakeholders, as well as commission a report on price gouging and how pricing structures factor into drug shortages.
In January, Klobuchar held a forum in Edina, Minnesota with Federal Trade Commission (FTC) Chairman Jon Leibowitz and Minnesota Attorney General Lori Swanson to discuss the drug shortages crisis and how to ensure patients have access to affordable medications. Klobuchar and Collins also recently took to the floor of the U.S. Senate to urge their colleagues to swiftly pass their legislation.