WASHINGTON, D.C. – U.S. Senator Amy Klobuchar announced today that the bipartisan drug shortages agreement she helped forge will be included in upcoming legislation being considered by the Senate Health, Education, Labor and Pensions (HELP) Committee. 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 bipartisan Senate working group which crafted the agreement, bringing together patients, doctors, pharmacists, manufacturers, and the FDA to reach consensus on a plan to help solve the drug shortage crisis.
“Doctors should be spending their time looking after their patients instead of looking for the drugs to treat them,” Klobuchar said.“Today’s announcement is a positive step forward for our bipartisan plan to help combat this crisis, and I will continue to work to pass this legislation as quickly as possible so we can stop these shortages from wreaking havoc on families’ lives.”
The bipartisan drug shortages 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) and cosponsored by Senator Susan Collins (R-ME) and 27 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 drug shortages 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. Klobuchar and Collins also recently took to the floor of the U.S. Senate to urge their colleagues to swiftly pass their legislation.