Blumenthal Demands Data About VA Contract With Compounding Pharmacy

HARTFORD — On October 19 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 23 people in 16 states.

Sen 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.”

Sen Blumenthal said in light of the extraordinarily troubling concerns raised about the safety of drugs manufactured by compounding pharmacy centers, he is seeking 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 outpatient clinics, and other facilities are from compounding pharmacy centers, and further, what internal mechanisms are in place to evaluate the safety of these products,” Sen Blumenthal concluded.

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