Blumenthal, Casey, Klobuchar Request More Information, Recommendations from HHS After Drug Shortage Hearing

(Washington, DC) – Senators Richard Blumenthal (D-CT), Bob Casey (D-PA), and Amy Klobuchar (D-MN) wrote Department of Health and Human Services (HHS) Secretary Kathleen Sebelius today, requesting that HHS provide “a comprehensive briefing on both the FDA hearing and subsequent recommendations under consideration by [HHS] at the earliest possible date” to continue to address the drug shortage crisis facing patients and health care providers across the country. The Senators had previously requested that the Food and Drug Administration (FDA) hold a public hearing on drug shortages, taking place today.

In the letter, the Senators write, “As Senators that have heard from countless constituents who are critically ill and whose care has been jeopardized by the current drug shortages, we have joined together to address this issue thoughtfully and comprehensively… To that end, we ask that you respond to us with a commitment on your availability to brief us on the FDA hearing, and any proposed recommendations under consideration as a result.”

The full text of the letter follows:

Dear Secretary Sebelius:

In June, we wrote to the Department to express our concerns regarding shortages of critical prescription drugs, and urged the FDA to hold a public hearing on this issue as soon as possible to help facilitate a meaningful discussion of potential solutions. Now, as this hearing commences and our nation’s patients, many in fear for their lives, continue to wait for relief, we respectfully request a comprehensive briefing on both the FDA hearing and subsequent recommendations under consideration by the Department at the earliest possible date.

As you know, in light of the urgency of the drug shortage crisis, we had asked that the public hearing would have been held sooner than late September. Nevertheless, we are encouraged by the Department’s decision to hold this hearing, as well as a pre-hearing meeting with stakeholders on September 9. We consider your inclusion in that meeting as a positive sign that the Administration views drug shortages as a serious and unprecedented public health threat that merits the highest levels of attention and action from our nation’s leaders.  

It is critical that as members of Congress and the Administration, we work immediately to act on the suggestions of stakeholders and move forward quickly to address this crisis. As Senators that have heard from countless constituents who are critically ill and whose care has been jeopardized by the current drug shortages, we have joined together to address this issue thoughtfully and comprehensively. Since the spring, our staffs have been meeting jointly with stakeholders to investigate this issue and we are hopeful that together we will be able to bring forward short- and long-term solutions to this crisis. 

We look forward to working with you and the relevant agencies to swiftly identify solutions and applaud both your commitment to addressing this issue, as well as Dr. Howard Koh’s statement following the September 9 meeting indicating that the Department intends to release a report with recommendations to address our nation’s drug shortage crisis. To that end, we ask that you respond to us with a commitment on your availability to brief us on the FDA hearing, and any proposed recommendations under consideration as a result.

We appreciate your efforts to ensure safe and timely availability of critical prescription drugs to all of our nation’s patients, and are committed to working with you to craft a permanent solution.   

Sincerely,

Richard Blumenthal
United States Senate                          

Robert P. Casey, Jr.
United States Senate

Amy Klobuchar         
United States Senate