Blumenthal Calls On VA To Explain Contract With Compounding Pharmacy Center Linked To Deadly Meningitis Outbreak

(Hartford, CT) – Today, in a letter to Department of Veterans Affairs (VA) Under Secretary for Health Robert Petzel, Senator Richard Blumenthal (D-Conn.) called on the VA to explain details of its contract with a compounding pharmacy center linked to the deadly meningitis outbreak that has killed 19 people in 15 states.

Blumenthal wrote, "Recent alarming information indicates that the Veterans Health Administration purchased roughly $20,000 worth of drug product from NECC, and more than $900,000 in drugs and related goods from Ameridose, LLC, a company with the same owners as NECC. I am deeply concerned that these purchases may have exposed veterans to a drug produced by a compounding pharmacy center that was not registered with the Food and Drug Administration and not inspected for safety and effectiveness."

Blumenthal continued, "In light of the extraordinarily troubling concerns raised about the safety of drugs manufactured by compounding pharmacy centers, please provide me with information about the monitoring and evaluation of the safety and effectiveness of such products purchased by the Veterans Health Administration. I would also greatly appreciate further information that clarifies exactly how much of the compounded pharmaceutical products utilized by Veterans Health Administration in hospitals, community based out-patient clinics, and other facilities are from compounding pharmacy centers, and further, what internal mechanisms are in place to evaluate the safety of these products."

Compounding is a process of combining, mixing, or altering ingredients in order to create a drug for a particular patient. Compounding pharmacy centers can make drugs for patients that are not typically available commercially, such as a drug made in a lower dosage for a child or a drug made without a dye or preservative for a patient with a specific allergy. Pharmacists that compound drugs have been subject to less federal regulation because they make drugs in response to a valid patient prescription, making the safety and efficacy trials required for drug manufacturing impractical and unnecessary. Compounding drugs without a patient prescription crosses the line from traditional compounding in limited quantities for a specific patient to mass production of drugs without proper FDA oversight.

Earlier this week, Blumenthal wrote a similar letter to the Department of Defense after learning of a sole source contract with Ameridose, a compounding pharmacy with the same owners as NECC. On October 8th, he wrote the Food and Drug Administration, requesting increased oversight of compounding pharmacy centers and on October 11th, he wrote the Department of Justice, requesting a criminal investigation into the outbreak.


Below is a text of the letter Blumenthal sent to the VA:

The Honorable Robert A. Petzel, M.D.
Under Secretary for Health
United States Department of Veterans Affairs Washington, D.C.  20420

Dear Dr. Petzel,

In recent months, the outbreak of Fungal Meningitis originating from the New England Compounding Center (NECC) has raised serious concerns about the apparent lack of scrutiny and oversight of such compounding pharmacy centers.

Recent alarming information indicates that the Veterans Health Administration purchased roughly $20,000 worth of drug product from NECC, and more than $900,000 in drugs and related goods from Ameridose, LLC, a company with the same owners as NECC. I am deeply concerned that these purchases may have exposed veterans to a drug produced by a compounding pharmacy center that was not registered with the Food and Drug Administration and not inspected for safety and effectiveness.

In light of the extraordinarily troubling concerns raised about the safety of drugs manufactured by compounding pharmacy centers, please provide me with information about the monitoring and evaluation of the safety and effectiveness of such products purchased by the Veterans Health Administration. I would also greatly appreciate further information that clarifies exactly how much of the compounded pharmaceutical products utilized by Veterans Health Administration in hospitals, community based out-patient clinics, and other facilities are from compounding pharmacy centers, and further, what internal mechanisms are in place to evaluate the safety of these products. I am sure that you share these concerns.

I will continue to work for all remedies addressing the lack of oversight and safety of drug manufacturing by compounding pharmacy centers like the NECC, which caused the widespread outbreak of a dangerous and deadly disease. I hope that we can work together to ensure that no contaminated drug products reach our veterans and to further strengthen the veterans’ health system.

Thank you for your assistance in addressing this matter promptly. I would appreciate either a written response to this letter or a briefing that is made available to my staff.

Sincerely,

Richard Blumenthal
United States Senate

A copy of the letter can be found here: http://www.blumenthal.senate.gov/download/va-petzel-letter