WASHINGTON, D.C. – U.S. Senator Amy Klobuchar announced today that the bipartisan drug shortages working group that she helped create has reached an agreement to help prevent critical drug shortages. The agreement includes Klobuchar’s early warning provision that would give the Food and Drug Administration (FDA) the tools it needs to help stop shortages before they occur. Klobuchar led the effort to form the working group, which brought together patients, doctors, pharmacists, manufacturers, and the FDA to reach consensus on a plan to help solve the drug shortage crisis. The proposed policies will be included in upcoming legislation being considered in the Health, Education, Labor and Pensions Committee.
“Patients’ energy should be focused on getting well - they shouldn’t be burdened with the added stress and worry of whether or not they will have enough medicine to treat their condition tomorrow,” Klobuchar said.“Today’s agreement would give the FDA important early warning tools to help prevent drug shortages before they occur. I will continue to work to move this bipartisan plan forward as quickly as possible so we can stop these shortages from wreaking havoc on families’ lives.”
The bipartisan working group agreement would require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage, which is the key provision in the Preserving Access to Life-Saving Medications Act, legislation Klobuchar introduced with Sen. Bob Casey (D-PA) last February. 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 working group 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. The agreement 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.