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Statement of Senator Harkin (D-IA) at the HELP Committee Hearing: “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak”

*As Prepared for Delivery*

“We are meeting here today to better understand what caused one of the worst public health crises this country has experienced in recent years: the meningitis outbreak that has claimed the lives of 32 Americans and sickened at least 461 people. 

            “While those affected grapple with side effects and complications related to treatment, thousands more are waiting to see if they become ill.  This outbreak has been traced back to pharmaceuticals produced at the New England Compounding Company in Framingham, Massachusetts, where owners and managers demonstrated a complete disregard for basic procedures to ensure that the products they were manufacturing were sterile.

“The question we will seek to answer today is: how could this have happened?  How could 17,000 doses of a product so contaminated that upon recall, black particles were visible to the naked eye, have been shipped to 23 states? 

“How could a pharmacy that the FDA had described in 2003 as posing, and I quote, the potential for serious public health consequences if [the] compounding practices, in particular those relating to specific sterile products are not improved, have been licensed to ship drugs to 45 different states?

            “As we have learned over the course of our Committee inquiry, NECC’s shortcomings were well-documented.  The FDA and the Massachusetts Board of Pharmacy repeatedly found significant deficiencies in NECC’s operations, including the suspected destruction of documents and contaminated lots; findings of bacterial contamination in compounded medications; findings of sterile injectable products that were both too weak or too strong in potency; and repeated complaints about the sale of compounded drugs without a patient-specific prescription, in direct violation of state and federal law.  And yet, despite the abundance of documentation, neither the Massachusetts Board nor the FDA appears to have taken the necessary steps to protect the public from these products. 

“Equally troubling is that fact that, when the owners and managers of NECC sought a license for a separate company, Ameridose, to compound drugs on scale perhaps ten times the size of NECC, these same state and federal regulators granted that license.  They did so without referencing the checkered history of NECC, even though Ameridose would supply hospitals across the country under contract with the largest group purchasing organization in the United States.  How could that history not been deemed relevant?  How could NECC’s owners have been allowed to expand their operations, in light of their history?  These are questions I am hoping to answer today.

“In the face of such a tragedy it is natural to want to take action.  And we will.  This Committee has a demonstrated ability to work to find bipartisan solutions that will take into consideration the needs of all stakeholders.  The hearing today will explore not just what happened, but it will begin to help us determine how to prevent similar outbreaks in the future.         

“What is important to remember, however, is that drug compounding is essential and that most pharmacies that compound do so on a vastly smaller scale than NECC.  We need to ensure that these pharmacists can continue to compound without a drastic increase in overhead. 

“We also know that to address drug shortages, compounding is occurring both in hospitals and in pharmacies to replenish supply of previously available drugs.  Indeed, in the case of methylprednisolone acetate, the drug at issue in the outbreak, two manufacturers had ceased producing the drug in the last two years.

“So we know compounding is critical, and that the need for large scale compounding is increasing.  But we do not know where or how much large-scale drug compounding is being conducted, or if these companies are compounding drugs in accordance with best practice standards. More importantly, we have no way of knowing which facilities are not in compliance.  This is a problem and indicates to me the need for better federal regulation in this area.

“As a Committee, we will work together to identify and plug any gaps in our regulators’ authority.  We want to ensure that any pharmacy that takes the kinds of risks with patient lives that NECC did will be shut down long before more patients get hurt.  The only good that can come from a tragic situation like this outbreak is the momentum to make changes to prevent it from ever happening again.  I look forward to hearing the thoughts of the panel on this topic and I promise the other members of this Committee who I know have a history on this issue to working together with you to ensure that a problem like this cannot occur again.

“In our first panel, we’ll hear from Dr. Beth Bell of the Centers for Disease Control and Prevention about the public health impact of the meningitis outbreak and CDC’s role in responding to it.  Dr. Peggy Hamburg of FDA and Dr. Lauren Smith of the Massachusetts Department of Public Health will talk to us about the role of their agencies in regulating compounding pharmacies in general and in investigating NECC specifically.  And we’ll ask them about their views on what we can do to prevent future crises. 

“We invited the manager and co-owner of the New England Compounding Center, Mr. Barry Cadden, to appear on our second panel.  We were informed by Mr. Cadden’s attorney that he would decline to voluntarily appear, and if compelled to appear, would invoke his Fifth Amendment right against self-incrimination and refuse to answer our questions.  I am disappointed by his failure to appear, but frankly, I believe this committee has amply demonstrated the extensive failures of Mr. Cadden and NECC, as the record of this hearing will make clear.  

‘On our third panel, we will talk to the physician whose critical work led to the initial identification of the outbreak and who ably worked with CDC to isolate NECC products as the source of the meningitis infections, Dr. Marion Kainer of the Tennessee Department of Health.  We’ll also talk with David Miller from the International Academy of Compounding Pharmacists and Dr. Kasey Thompson of the American Society of Health-System Pharmacists about the use of compounding in medical care, and the measures needed to ensure that compounded drugs are safe.

“Before we begin, I’d like to submit to the record the documents that we have received from NECC, FDA, and Massachusetts in response to our investigatory letters.”