By Sally Greenberg, NCL Executive Director, and Ayanna Johnson, NCL Health Policy Associate
This past week, the House and Senate held hearings on the fungal meningitis outbreak and the state of compounding pharmacies in the US. Both the current FDA Commissioner, Dr. Margaret A. Hamburg, and the Massachusetts Department of Health Interim Commissioner, Dr. Lauren Smith, testified at the hearings, offering accounts of the roles their respective agencies played in the issue. The hearings highlighted the slipshod practices of drug compounding by the New England Compounding Center (NECC) in Massachusetts, which at times reached a scale of production resembling drug manufacturing. The co-owner of NECC, Barry Cadden, was subpoenaed and present at the House committee hearing, but invoked his 5th amendment right. The hearings are a part of the ongoing investigation into the outbreak and what can be done to prevent future threats to public health, like this, from happening again.
To date, the outbreak has left 34 patients dead, over 400 sickened and more than 14,000 patients who received injections wondering what is next. At the House hearing, the wife of a deceased victim gave a compelling account of her husband’s unexpected and rapid demise due to receiving a contaminated injection to relieve pain, stemming from a car accident. One thing was clear from her account: she and her family “have lived a nightmare” and had no idea what was happening to her husband. Unexplained headaches and periodic numbness were the only symptoms that signaled something was going terribly wrong. Stories like these put a name and face to the tally of victims. Our thoughts and condolences go out to all those who have lost loved ones or had loved ones sickened by this outbreak. Patients and consumers should be able to rest assured that their medicines are safe; the House committee members pledged to provide bipartisan support to finding a solution.
Since its opening in 1998, NECC has come under fire for numerous violations at both the state and federal levels. The hearings often focused on a timeline of events where NECC was inspected, was cited for violations and unlawful interstate commerce, or even risked closure for copying a manufactured prescription drug. NECC’s consistent interaction with government begs the question why was something not done earlier, but—as pointed out by numerous testimonies—the authority with which FDA can act in these situations is unclear. In fact, Dr. Hamburg brought a map of FDA jurisdiction over compounding pharmacies across the US, describing it as a patchwork of laws lacking clear lines of regulatory oversight.
Neither Dr. Hamburg nor Dr. Smith were heading their respective agencies when the state board of pharmacy or FDA interacted with NECC, each described her role, potential next steps, and why FDA’s jurisdiction over compounding pharmacies needs to be clarified through legislation. As we sat in the hearing room, we were startled at the questions directed at Dr. Hamburg by certain Committee members. They struck us as disrespectful and offensive. Committee members demanded a yes or no answer for complicated issues. There is a difference between compounding and drug manufacturing, which lawmakers must recognize in order to make substantive headway in creating an effective law. Additionally, the compounding industry has evolved substantially and new laws are required to reflect that. We appreciate the close regulatory attention that Dr. Hamburg and Dr. Smith are advocating for, to ensure that tainted drugs never get into the marketplace.
One congressman asked the FDA what it would need to prevent this from happening again, which we thought this was constructive. While it is important to determine what went wrong, pointing fingers and playing the blame game will not protect consumers and patients in the end. Finding out how to increase our public health agencies’ power to protect is important.
Dr. Hamburg agreed that FDA was in need of increased funding if all compounding pharmacies are to fall under FDA jurisdiction. The 7,500+ compounding pharmacies need to be registered with the FDA, and currently they are not. Dr. Hamburg also proposed a tiered system of management for compounding pharmacies that leaves traditional compounding under the jurisdiction of the state, and non-traditional compounding becomes FDA regulated. The Senate committee commended the work of the Centers for Disease Control (CDC) in investigating and reporting on the outbreak. It was encouraging to see Congress recognize the importance of public health, and the need for continued funding to support its efforts in the broader health care arena.
As the events surrounding the meningitis outbreak continue to unfold and more holes in regulation are exposed, it is important that efforts are directed to closing these gaps in the law. FDA’s commitment to bring those compounding pharmacies that are actually making drugs under its regulatory umbrella is laudable and the appropriate next step. The president of the International Association of Compounding Pharmacies also testified at the Senate hearing that legislators would have his organization’s support and commitment to collaborate on a bill to protect the public’s health. We hope he makes good on that promise.
Finally, the National Consumers League also calls on all members of Congress to support legislation introduced by Congressman Ed Markey (D-MA) —whose district includes NECC headquarters—to clarify FDA’s regulatory role and that of the state health departments and require registration of these pharmacies and labeling of all products they make.