WASHINGTON, D.C. —Today the senior Democratic appropriators for the Departments of Health and Human Services (HHS) and Veterans Affairs (VA), Congresswoman Rosa DeLauro (D-CT) and Congressman Sanford Bishop (D-GA), sent a letter to HHS Secretary Kathleen Sebelius and VA Secretary Eric Shinseki urging them to protect seniors, veterans and other patients by ensuring the safety of compounded medications.
“As the investigation of the tragic outbreak of fungal meningitis associated with products from the New England Compounding Center (NECC) continues, it is imperative that we act to protect patient safety,” the appropriators write. “This should include for seniors, veterans, and others that participate in the federal programs under Medicare, Medicaid, and the Veterans Health Administration. This is particularly critical as it has been revealed that Veterans Affairs Medical Centers have purchased products from both NECC and the related company Ameridose. Over 250 American patients have become ill including 20 that have died because of contaminated medical products from this one compounding facility. This type of outbreak should be preventable, and we would hope that private insurance companies will take similar steps to protect their patients.”
Details on the recall may be found here and information on the fungal meningitis outbreak may be found here.
###
The letter is as follows:
October 19, 2012
The Honorable Kathleen Sebelius The Honorable Eric Shinseki
Secretary Secretary
Department of Health and Human Services Department of Veterans Affairs
200 Independence Avenue, S.W. 810 Vermont Avenue, N.W.
Washington, D.C. 20202 Washington, D.C. 20420
Dear Secretary Sebelius and Secretary Shinseki,
We write today to encourage you to ensure the safety of compounded medications used by patients enrolled in health plans run by the Federal government including Medicare and Medicaid, as well as veterans receiving care through the Veterans Health Administration.
As the investigation of the tragic outbreak of fungal meningitis associated with products from the New England Compounding Center (NECC) continues, it is imperative that we act to protect patient safety. This should include for seniors, veterans, and others that participate in the federal programs under Medicare, Medicaid, and the Veterans Health Administration. This is particularly critical as it has been revealed that Veterans Affairs Medical Centers have purchased products from both NECC and the related company Ameridose. Over 250 American patients have become ill including 20 that have died because of contaminated medical products from this one compounding facility. This type of outbreak should be preventable, and we would hope that private insurance companies will take similar steps to protect their patients.
We believe part of our response should include additional authority for and improved communication between federal and state regulators to ensure unequivocal oversight of compounded products and manufacturers that masquerade as pharmacies. Patients expect their medications and products used in the health care setting to be safe, effective, and overseen by the Food and Drug Administration (FDA).
Yet, we must not risk patient care as Congress considers how to best work to prevent illnesses from contaminated compounded products in the future. In the immediate term we must strengthen guidance to industry, health care providers, and consumer information to patients in order to further assure the safety of compounded medications. This should include requiring that any compounding pharmacy used by the aforementioned programs meets minimum standards like those described by the United States Pharmacopeial Convention and used by the Pharmacy Compounding Accreditation Board. This is especially important for sterile injectable medications such as those involved in the ongoing outbreak. And, this should be done expeditiously using your existing authority including, if necessary, rulemaking.
In addition, to better ensure the safe production of these medications, we also urge you to require that these compounded products be clearly labeled as such and that patients receive information on the differences between compounded and FDA-approved products. Finally, we recommend that you ensure strong auditing of this requirement to verify its effective implementation.
Such short term actions should not be the final resolution or an excuse for Congress to abdicate its responsibility to strengthen protections for the American public. They are, however, critical efforts to help ensure patient safety as Congress considers the appropriate legislative response to any shortcomings identified by the investigation.
Thank you for your continued work to ensure that Americans have access to affordable, safe medications.
Sincerely,
ROSA L. DeLAURO
Member of Congress
SANFORD D. BISHOP, JR.
Member of Congress