WASHINGTON, DC—U.S. Senator Bob Casey (D-PA), a leading voice in the Senate for action to address ongoing prescription drug shortages, today joined a bipartisan effort to urge the U.S. Department of Health and Human Services (HHS) to hold a public hearing on the dangerous issue of prescription drug shortages as soon as possible. In a letter HHS Secretary Kathleen Sebelius, U.S Senators Richard Blumenthal (D-CT), Richard Burr (R-NC), Bob Corker (R-TN), Amy Klobuchar (D-MN) and John McCain (R-AZ) joined Senator Casey in expressing a growing urgency to deal with shortages that are adversely affecting patient care.
“Given the growing severity of this problem, we strongly urge you to hold a public hearing on this issue as soon as possible in order to help facilitate a meaningful discussion of potential solutions to address these shortages,” the Senators wrote.
Senator Casey requested a public hearing on the issue in letters to the FDA in December 2010 and April 2011. The FDA has a public meeting scheduled in September, but the Senators today expressed the need to quicken the pace of action.
“While we appreciate this progress, the Department’s actions must reflect the urgency of this matter and we believe that a hearing in September falls short of this objective,” the Senators wrote. “Therefore, we strongly urge you to work with the FDA and other relevant operating divisions within the Department to convene this public meeting at the earliest possible date.”
Senators Casey and Klobuchar have introduced the Preserving Access to Life-Saving Medications Act, which will require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage.
The full text of the letter is below.
Dear Secretary Sebelius:
We write today out of growing concern regarding the increasing reports of shortages of critical prescription drugs and the serious threat these shortages pose to our nation’s patients and public health. We have heard from patients and health providers in our states expressing concern with respect to the urgency of these shortages and the adverse impact they have on patient care. Given the growing severity of this problem, we strongly urge you to hold a public hearing on this issue as soon as possible in order to help facilitate a meaningful discussion of potential solutions to address these shortages.
The underlying causes of drug shortages appear to be complex and multifaceted, with far-reaching implications that can deeply affect both the quality and cost of care that patients receive. Therefore, we request that the hearing be comprehensive in nature and include the participation of relevant senior officials at the Department of Health and Human Services (HHS), including representatives of the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), as well as the full range of stakeholders, including representatives of drug manufacturers, distributors, health providers, and patients.
In prior letters to the FDA in December 2010 and April 2011, Senators Casey and Blumenthal expressed concerns and requested an FDA public hearing on this developing problem. We understand that the FDA has set a date of September 26, 2011 for a public meeting on this issue. While we appreciate this progress, the Department’s actions must reflect the urgency of this matter and we believe that a hearing in September falls short of this objective. Therefore, we strongly urge you to work with the FDA and other relevant operating divisions within the Department to convene this public meeting at the earliest possible date. We ask that you respond to us by July 1, 2011 with a commitment and update on progress for this hearing.
Over the years, Congress and the Executive Branch have been able to successfully work together to solve some of the greatest health care challenges facing our nation. As members both on the principle authorizing committee and off, we look forward to working with the Department moving forward to address the increasing shortages of prescription drugs and achieve the important goal of ensuring our nation’s patients have access to the quality and timely care that meets their needs.
Sincerely,
Robert P. Casey, Jr.
Richard Blumenthal
Richard Burr
Bob Corker
Amy Klobuchar
John McCain
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