DeLauro, Sanford Bishop Seek To Ensure Safe Compound Drugs For Seniors, Veterans
Urge HHS and VA Secretaries To Protect Patients Now
WASHINGTON, DC—Today the seniorDemocratic appropriators for the Departments of Health and Human Services (HHS)and Veterans Affairs (VA), Congresswoman Rosa DeLauro (D-CT) and CongressmanSanford Bishop (D-GA), sent a letter to HHS Secretary Kathleen Sebelius and VASecretary Eric Shinseki urging them to protect seniors, veterans and otherpatients by ensuring the safety of compounded medications.
"As the investigation of the tragic outbreak of fungalmeningitis associated with products from the New England Compounding Center(NECC) continues, it is imperative that we act to protect patient safety," theappropriators write. "This should include for seniors, veterans, andothers that participate in the federal programs under Medicare, Medicaid, andthe Veterans Health Administration. This is particularly critical as ithas been revealed that Veterans Affairs Medical Centers have purchased productsfrom both NECC and the related company Ameridose. Over 250 Americanpatients have become ill including 20 that have died because of contaminated medicalproducts from this one compounding facility. This type of outbreak shouldbe preventable, and we would hope that private insurance companies will takesimilar steps to protect their patients."
Details on the recall may be foundhere andinformation on the fungal meningitis outbreak may be found here.
The letter is as follows:
October 19, 2012
The Honorable Kathleen Sebelius TheHonorable Eric Shinseki
Secretary Secretary
Department of Health and HumanServices Departmentof Veterans Affairs
200 Independence Avenue,S.W. 810 VermontAvenue, 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 medicationsused by patients enrolled in health plans run by the Federal governmentincluding Medicare and Medicaid, as well as veterans receiving care through theVeterans Health Administration.
As theinvestigation of the tragic outbreak of fungal meningitis associated withproducts from the New England Compounding Center (NECC) continues, it isimperative that we act to protect patient safety. This should include forseniors, veterans, and others that participate in the federal programs underMedicare, Medicaid, and the Veterans Health Administration. This isparticularly critical as it has been revealed that Veterans Affairs Medical Centershave purchased products from both NECC and the related company Ameridose. Over 250 American patients have become ill including 20 that have died becauseof contaminated medical products from this one compounding facility. Thistype of outbreak should be preventable, and we would hope that privateinsurance companies will take similar steps to protect their patients.
We believe partof our response should include additional authority for and improvedcommunication between federal and state regulators to ensure unequivocaloversight of compounded products and manufacturers that masquerade aspharmacies. Patients expect their medications and products used in thehealth care setting to be safe, effective, and overseen by the Food and DrugAdministration (FDA).
Yet, we must notrisk patient care as Congress considers how to best work to prevent illnessesfrom contaminated compounded products in the future. In the immediateterm we must strengthen guidance to industry, health care providers, andconsumer information to patients in order to further assure the safety ofcompounded medications. This should include requiring that anycompounding pharmacy used by the aforementioned programs meets minimumstandards like those described by the United States Pharmacopeial Conventionand used by the Pharmacy Compounding Accreditation Board. This isespecially important for sterile injectable medications such as those involvedin the ongoing outbreak. And, this should be done expeditiously usingyour existing authority including, if necessary, rulemaking.
In addition, tobetter ensure the safe production of these medications, we also urge you torequire that these compounded products be clearly labeled as such and thatpatients receive information on the differences between compounded andFDA-approved products. Finally, we recommend that you ensure strongauditing of this requirement to verify its effective implementation.
Such short termactions should not be the final resolution or an excuse for Congress to abdicateits responsibility to strengthen protections for the Americanpublic. They are, however, critical efforts to help ensure patientsafety as Congress considers the appropriate legislative response to anyshortcomings identified by the investigation.
Thank you foryour continued work to ensure that Americans have access to affordable, safemedications.
Sincerely,
ROSA L. DeLAURO
Member of Congress
SANFORD D. BISHOP, JR.
Member of Congress