U.S. Senator Amy Klobuchar today called for a Senate hearing to address the urgent drug shortages crisis facing hospitals and pharmacies. In a letter to the Senate Health, Education, Labor and Pensions (HELP) Committee, Klobuchar and other members of the Senate bipartisan drug shortages working group urged the Committee to hold a hearing to discuss possible legislative solutions to the problem. Klobuchar has introduced legislation to provide the Food and Drug Administration (FDA) with key tools to address and prevent shortages of prescription drug medications.
"Shortages of critical prescription drugs have forced delays in treatment for patients across our nation who require these often lifesaving medications for the treatment of serious and chronic medical conditions, including cancer,"Klobuchar said. "A HELP Committee hearing would provide a timely opportunity to build on the work of the bipartisan drug shortages working group, and allow for experts from the FDA, physicians, patients, and the pharmaceutical industry to explore legislative solutions."
Other members who signed the letter include Senators Bob Casey (D-PA), Richard Blumenthal (D-CT), and Jeff Merkley (D-OR).
The Preserving Access to Life-Saving Medications Act, introduced by Senators Klobuchar and Bob Casey (D-PA), would give the FDA the ability to require early notification from pharmaceutical companies when a factor arises that may result in a shortage. These factors may include changes made to raw material supplies, adjustments to manufacturer production capabilities, and certain business decisions such as mergers, withdrawals, or changes in output. The bill would also direct the FDA to provide up-to-date public notification of any actual shortage situation and the actions the agency would take to address them. The FDA has prevented 99 drug shortages so far this year due to voluntary early notifications from companies, up from 38 in 2010. During a recent FDA workshop, FDA officials said that rise in preventions is due to increased pressure from Klobuchar and other members of Congress.
President Obama recently signed an Executive Order advancing the key provision in the bill, which would urge pharmaceutical companies to voluntarily notify the FDA of impending prescription drug shortages.
Klobuchar's bipartisan drug shortages working group, which includes Senators Bob Casey (D-PA), Richard Blumenthal (D-CT), Richard Burr (R-NC), John McCain (R-AZ), and Bob Corker (R-TN), is aimed at bringing together patients, doctors, pharmacists, manufacturers, and the FDA to stop drug shortages. Klobuchar, Blumenthal, and Casey also sent a letter earlier this year to Health and Human Services Secretary Kathleen Sebelius requesting a comprehensive briefing on both the FDA hearing and the subsequent recommendations under consideration.