Suggests New Model For Regulating Compounding Pharmacies
At a Senate hearing on the deadly meningitis outbreak, Senator Lamar Alexander (R-Tn.) on Thursday called for a new model of oversight of sterile compounding pharmacies that would give one agency “full accountability and responsibility.”
Senator Alexander said: “My experience as governor is that whenever I gave a job to more than one person, sometimes it came back not done. But when I put one person on the flagpole, it was surprising to see how assigning responsibility got it done….It seems to me that one guiding principle of working this out is: Let’s stop this dual responsibility. Let’s put either state boards of pharmacy on the flagpole or the FDA on the flagpole, and get the other one out of it.
“This has been a nightmare for Tennesseans, as it has been for any Americans affected. Thirteen Tennesseans have died, 81 Tennesseans are sick, a thousand more have been exposed. And all of us are shaken because we live in this country where we have this miracle of being able to walk into one of our 60,000 drugstores or pharmacies, or of going to our doctor or a pain clinic and getting medicine–we don’t think about it, we just assume it’s safe. But then to suddenly go home and find out that you’ve got fungal meningitis and you may die or be permanently disabled is a nightmare–not just for the families involved, especially them, but for all of us.”
The Senate Health, Education, Labor and Pensions Committee, of which Senator Alexander is a member, held the hearing titled “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.” Alexander, who is likely to become its Ranking Member in the next Congress, said he is working with chairman Sen. Tom Harkin (D-Iowa) and the committee on legislation to be introduced early in the next Congress.
At the hearing, Senator Alexander suggested a new model of oversight for sterile compounding pharmacies such as the New England Compounding Center, the source of the contaminated drugs: “Would it be conceivable that we’d have a system where [FDA] would have responsibility but [be] able to delegate that responsibility to those states that are willing to meet federal standards? [FDA’s] job would be more like, say, the Nuclear Regulatory Commission, where…[FDA] wouldn’t regulate the facilities, but would basically be regulating the states that took on that function?”
Senator Alexander suggested the FDA could “certify a state agency as adequate to [regulate] sterile compounding or inadequate to do it.”
Dr. Peggy Hamburg, commissioner of the Food and Drug Administration, said, “I think we need to discuss the range of options but that would certainly be one model that could work.”
Senator Alexander said, “The FDA could set standards and certify the state to handle that narrow area of compounding–and be able to take it away. For example, in the case of Massachusetts, if there had been such a structure, then based upon what I’ve heard today, if FDA had the authority, it should jerk the ability of Massachusetts to deal with these sorts of entities at least until Massachusetts cleaned up its act. On the other hand, it should give Tennessee an award for working with the CDC to move quickly to eliminate the spread.”
In introducing Dr. Marion Kainer, director of the Healthcare Associated Infections and Antimicrobial Resistance Program for the Tennessee Department of Health, at today’s hearing, Senator Alexander praised Dr. Kainer’s quick response and swift action on the outbreak. In days of hearing of the first case of fungal meningitis in Tennessee, Dr. Kainer had reached out to the Centers for Disease Control and tracked down the source of the illness.
Dr. Kainer was invited to testify at the hearing by the committee, at Senator Alexander’s request.
Senator Alexander also sent letters to the Tennessee Department of Health, the Tennessee Board of Pharmacy, the Tennessee Pharmacists Association, Tennessee Medical Association, the Tennessee Hospital Association, and the Tennessee Board of Medical Examiners, inviting them to submit testimony for the record on this issue.
In October, Senator Alexander, along with a bipartisan group of senators serving on the Senate Health, Education, Labor and Pensions Committee, sent letters to the FDA, Massachusetts Board of Pharmacy, and NECC owners, seeking information related to the outbreak. He also joined Senator Bob Corker (R-Tn.) in sending a letter to FDA Commissioner Margaret Hamburg asking for clarity regarding existing laws governing oversight of compounding pharmacies like NECC and information about any inspections of NECC and actions taken since the FDA warned the center in December 2006.
Senator Alexander also submitted the following statement for the record:
“Mr. Chairman, thank you for holding this hearing today on the ongoing outbreak of fungal meningitis caused by tainted medicines from the New England Compounding Center (NECC). This tragic outbreak has caused 32 deaths across the nation, including 13 Tennesseans – 461 people across the nation have contracted meningitis, including 81 Tennesseans, and this never should have happened.
“In the United States, there are over 60,000 drug stores, and one of the miracles of the modern era is going into a pharmacy and filling a prescription for a medicine and knowing it is safe. Whether it is for your blood pressure or aspirin, you have confidence in that medicine, so what has happened here is shocking. We are talking about medications that were supposed to be safe, called sterile injections – medicines prescribed by a doctor and compounded by a Massachusetts compounding pharmacy, and then injected into people’s spines to help relieve back pain. What we’ve learned is that this medicine turned out to be tainted – it was unclean and not safe. This kind of safety failure makes one wonder about all medicines, but today we are focusing on compounded prescription drugs.
“It is important to note that traditional compounding of medicines, which is when a licensed pharmacist makes changes to an FDA approved drug to meet an individual patient need, is a very important part of our health care system. For example, compounding is necessary if a patient is allergic to an inactive ingredient in an approved drug, or when a child needs a lower dosage if there is no pediatric formulation of an existing drug.
“Compounding happens in one form or another in a majority of our sixty-thousand pharmacies. Some of it is non-sterile, which means the production of solutions, suspensions, ointments and creams, powders, suppositories, capsules and tablets; and some of it is sterile, which means the production of medications that must be free of microorganisms, such as those used for injections or instillation of the eyes.
“According to the International Academy of Compounding Pharmacists, more than half of the community-based pharmacies provide some level of basic compounding services to local patients and physicians, and there are 7,500 pharmacies in the United States that specialize in advanced compounding services, of which approximately 3,000 provide sterile compounding.
“What seems to have gone wrong is that this pharmacy in Massachusetts was masquerading as a compounding pharmacy but really was a drug manufacturer, where the scrutiny and regulatory power of the FDA is much clearer. It is hard to say that this tragedy absolutely would not have happened, but it seems less likely because the regulatory system is strong when it comes to manufacturers.
“According to the Tennessee Department of Health, “Tennessee received a large amount of the contaminated steroid injections from NECC impacting 1,009 people, but the number of cases has dropped considerably during the past few weeks and the risk continues to drift down over time, but unfortunately we don’t know when it ends.” So the numbers of affected people are dropping, which is good, but people are still wondering if they are going to get sick from an injection they got months ago.
“I have three questions I would like to ask on behalf of the 32 dead across this country, including 13 Tennesseans, and the 461 people that have contracted meningitis across the country, including 81 Tennesseans, and the thousands more that received tainted injections from NECC and have been waiting to see if they will come down with meningitis.
“I think the first question that all of those patients and their families want to know is, how in the world did this happen? Who is responsible for this breach of public trust?
“Second, whose job should it be to define and regulate large compounding pharmacies: the Food and Drug Administration (FDA), or the Massachusetts Board of Pharmacy and other state boards of pharmacy?
“Finally, why weren’t the federal and state regulators talking to each other about the New England Compounding Center with which they both clearly had concerns?
“On Sept. 18, two months ago, an astute clinician at Vanderbilt University identified and reported a case of fungal meningitis to Dr. Marion Kainer with the Tennessee Department of Health. Dr. Kainer’s quick response to this earliest case of fungal meningitis in Tennessee helped to quickly narrow the course of the fungal infections and limit the number of victims who received the contaminated injections nationwide.
“The Executive Director of the Association of State and Territorial Health Officials was quoted in The Tennessean as saying, “by the time we learned this was a problem around the country, the information from Tennessee had already narrowed it down to what the problem was,” and the Tennessee Department of Health’s response “was a textbook case of how to do it right.”
“Her testimony will be critical to our understanding of the outbreak and to what improvements could be made to help state health departments responding to public health crises.
“Additionally, the FDA and the Centers for Disease Control and Prevention should be commended for their quick response and coordination with and support to states as soon as they were notified of the outbreak and during their investigations of the outbreak.
“I hope that we are able to learn enough today to begin to be able to address some of these issues around how this outbreak managed to occur and how we can prevent something this devastating from happening again.”