Blumenthal Questions Witnesses at Senate Hearing On Deadly Meningitis Outbreak

(Washington, DC) – Today, U.S. Senator Richard Blumenthal (D-Conn.) participated in a U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee hearing entitled “Pharmacy Compounding: Complications of the 2012 Meningitis Outbreak.” This hearing sought to examine how statutory and regulatory shortfalls contributed to the fatal contamination of injectable steroids compounded by the New England Compounding Center (NECC) and to examine potential solutions to prevent future crises. To date, 461 people have become ill and 32 people have died as a result of using the contaminated injectable steroids. The Centers for Disease Control estimates that nearly 14,000 patients nationwide may have received contaminated injections.

During his questions to the Commissioner of the Food and Drug Administration (FDA), Dr. Margaret Hamburg, Blumenthal highlighted the need for more federal oversight in light of the fact that NECC experienced significant failures in the past that may be replicated without stronger oversight. Blumenthal also recognized the FDA's need for more resources to crack-down on compounding centers.

A video of Blumenthal's question-and-answer session with Dr. Hamburg can be found here: https://lfts.senate.gov/seos/1000/mpd/ui01122012650b00d1392db2c84f26b8d02244df27

Below is a transcript of Blumenthal's question-and-answer session with Dr. Hamburg.


Question & Answer Part One

Blumenthal: My thanks to you and Senator Enzi for holding this hearing as I suggested and urged that you do in the wake of this tragedy. And let me express my sympathy to the families and individuals that have been affected by it and also my respect for commissioner Hamburg and the excellent institution that you lead. Unfortunately, having reviewed many of these documents, having spoken to experts in the field, having reviewed the history, I think the conclusion here is inescapable that this tragedy could and should have been prevented by more effective enforcement of existing laws. NECC was a known risk to both federal and state regulators but both failed to take any dispositive and effective action to stop this kind of tragedy. Action that could have been taken against both NECC and Ameridose – and in effect they were disasters waiting to happen. In fact, they waited to happen for about a decade and going through the history I understand your view that the FDA’s authority was, as you have said and I think you’ve used this formulaic expression a number of times, contested, limited, and unclear but so is a lot of federal authority and state authority and it’s used effectively to prevent wrongdoing and law-breaking by companies like NECC that can not only imperil the health of people but actually kill them as this company did through its contaminated product. So I think that a lot of the questioning that you’re seeing here reflects a skepticism on the part of Congress and the public about whether the FDA will use this enhanced authority more effectively than it’s used the authority that it has had up to date. And I think that the assurance that the FDA now has to give, is that it will be vigorous and zealous in using new authority if it’s given that authority and I think that is a challenge for the agency at this point, it’s a challenge for the federal government, certainly for state authorities as well, but we don’t have jurisdiction over them. I would suggest to you that the jurisdictional question ought to be resolved very simply and starkly. If a company manufactures drugs, you regulate them now do you not?

Hamburg: Drug manufacturers we regulate, yes. 
 
Blumenthal: In other words, if a company produces pharmaceutical drugs, without a specific patient prescription, they are regulated by the federal government and that ought to be the rule.

Hamburg: But, as I understand it, that is not currently in fact in the law.

Blumenthal: But it certainly was the intent of Congress. And those decisions that so swayed the FDA to avoid asserting its authority and jurisdiction were also unclear, limited, and contested. And an enforcer knows in that situation the only way to protect the public is to use what authority he or she has. And in this instance, whether it’s in 2004, the inspection report that involved the FDA, 2006, where a warning letter was issued, NECC never responded until 2007 and then the FDA never got back to them until 2008, and the FDA failed to use its existing authority and I’m suggesting to you that the jurisdiction ought to be asserted as widely and effectively as possible and that there be no ambiguity in the law as there is now. So to the extent that you use a multi-tiered, complicated, differentiated approach, you will embark on the same type of perilous voyage that you have in the past.

Hamburg: If I can make two quick points. I completely agree with what you’re saying and frankly I wasn’t there but I wish that the responses had been more timely, there had been better communication with the states, and that the outcome had been different. As far as using our existing authorities during my tenure, we have tried to be proactive or aggressive in responding to problems that come before us. There have been a series of incidents where we’ve had problems with contaminated products for intraocular injection, or problems with other compounded products. And we have moved in quickly as soon as we heard about the cases, done the inspections, gotten the companies to recall the products. In most of the cases in fact, they’ve stopped compounding sterile products. In one instance that was actually a veterinary case that occurred right before I became commissioner, we decided to go after the compounding pharmacy after 21 horses were killed because of super potent medication they were provided by a compounding pharmacy. We lost in court. Later we had a problem with that same compounding pharmacy for an important human medical product and there was serious injury as a result. We went back in, we recalled the product, we got them to stop practices and they’re not compounding now. So we have to use the authority we have but it is reactive. What I would like would be to have a system in place that was statutorily defined, that would assign roles and responsibilities, that would define standards of quality practice that would help us to prevent problems from happening in the first place. Just looking at the map in terms of how the statute governing our oversight of compounding pharmacies currently exists, it applies in some parts of the countries and not others and there’s a big gray area. That can’t be good for anyone. So what I’m saying, as Senator Roberts said, this is certainly the most tragic of the cases we’ve seen, but for more than a decade there have been problems in this area. And there will be more problems unless we really work together to make sure we have the overriding legal authorities that are strong and clear and explicit. I just think we can do better.

Blumenthal: Well I agree, and I apologize Mr. Chairman because my time has long expired, but overriding is the key word. Overriding local authorities that may be reluctant to enforce. Your job, and it is uniquely and always the job of the federal government to establish standards that protect the public health and safety where there is a national impact. Clearly there is a national impact here. Where there is a drug compounding pharmacy, whatever terminology you want to use, traditional, non-traditional, big, small, if they manufacture a drug, if they make it without a specific individual prescription, that’s manufacturing. You do that now, why not for these as well. Thank you, Mr. Chairman.

Question & Answer Part Two

Blumenthal: I’ve reviewed all the documents, Form 483 inspection reports, clearly serious egregious violations of basic standards were found by your inspectors in 2008 and then again in 2010. Now I take it that the recommendation was made for a warning letter to be issued. There is no evidence in the documents submitted to this committee that any warning letter was ever sent. Do you disagree?

Hamburg: That is my understanding.

Blumenthal: There was no warning letter ever sent despite findings about the lack of potency in the drugs, the lack of proper sterility standards, the basic cleanliness and other kinds of minimal standards in a company that is many times the size of NECC, manufacturing hundreds of different kinds of products sent across the nation. And no warning letter was issued, was that correct?

Hamburg: The product was recalled, however, but my understanding is that no warning letter was ever sent.

Blumenthal: Why was no warning letter issued?

Hamburg: You know we are looking into that and as I said some of the specifics are part of an ongoing investigation internally and more broadly.

Blumenthal: And there is no question in your mind is there, because there wasn’t in any of the inspectors who did these reports, that FDA had full and complete authority over Ameridose.

Hamburg: You know as I said it did – it was something about hybrid in terms of being a repackager pharmacy. It wasn’t a drug manufacturer you know like (inaudible) and Pfizer –

Blumenthal: You’re telling the committee it was not a drug manufacturer?

Hamburg: It was not a drug manufacturer in the sense of, a drug manufacturer that we have the oversight of in terms of, new products that undergo, you know, product review and approval before licensure that are subject to, all of the --

Blumenthal: Your inspector in the jurisdiction section of the report in 2010 said the firm currently repacks and manufactures prescription drug products which are FDA regulated drug products.

Hamburg: You know as I said at the outset, Ameridose is actually the subject of an ongoing investigation and you understand what that entails, so I’ve been asked not to try and characterize Ameridose at this time as we’re looking into, you know those very questions that you’re asking.

Blumenthal: Well let me ask you a broader question which looks to the future rather than the past. And I want to reiterate that much of the documents and issues that have been brought to the committee [date] to a time before you took over the position that you have now, and we’re asking both you and Ms. Smith to answer questions about institutional performance well before your responsibility. But looking to the future, if there is an NECC and an Ameridose continuing to operate out there, do you know who they are? In other words, if you had that authority, today, do you know where you would go in terms of where the problems are, the future tragedies waiting to happen?

Hamburg: We do not know the universe of compounding pharmacies that might fit into this category of activity because they are not required-

Blumenthal: Shouldn’t you know?

Hamburg: I do think that we should know and I would like to see that as part of new legislation –

Blumenthal: But you can begin that task right now, can’t you?

Hamburg: Well we are beginning to reach out to our colleagues at the state level to learn more information and are enhancing our activities around some of the large compounding facilities that we know about to really make sure that we have as much information about what they are doing and how they are doing it.

Blumenthal: Well, let me just suggest, and I don’t mean to sound simplistic because I know your task is resource challenged and we haven’t really discussed the resource issue but I know it is one that is very much a challenge for the FDA at this point and the Congress really should be meeting its obligation to provide those resources that are necessary for the tasks that we’re all implying you should have been carrying out. But I would suggest very respectfully that the FDA ought to make it a priority to scrutinize the 3,000 compounding pharmacies. The documents that are public, and most of these documents are public right now as we’ve seen from the media they are available to folks who want to go into the records to find them. And where are the next tragedies going to occur? Who will cause them? What kind of standards are they failing to meet? So that when you’re provided with that authority that is not as limited, unclear, and contested as you say it is now, you can swoop down on them and shut them down or at least require that they correct the problems that exist.

Hamburg: Well, I really appreciate your observations including the one on resources because that is a huge challenge, and we have enormous responsibilities for the protections of the public health across a huge domain of areas of activity. I hope that I can work with you to address the crazy quilt of regulatory oversight that we currently have because that will enable us to act in a much more efficient and targeted way. I also do think that the more we can be preventive as you say rather than reactive using our authorities that are clearly in the law to address a contaminated product, but we don’t want to have to wait until there is a contaminated product, we want to be able to make sure that these facilities are operating the kind of preventive controls and standards of quality that the American people expect and deserve.

Blumenthal: Well I would just suggest that you be preventive with capital “P” here, and that you regard these renegade outlier drug manufacturers as the threat to public health which clearly they are. Thank you, Mr. Chairman.


Blumenthal has been a leader in calling for stronger federal oversight of compounding pharmacies and investigations into the company that manufactured the contaminated injectable steroids. Since the fungal meningitis outbreak, Blumenthal has done the following:

1)      Sent a letter to the commissioner of the FDA, calling for stronger federal oversight of compounding pharmacies that manufacture drugs without a patient prescription;

2)      Called on U.S. Attorney General Eric Holder to open a criminal investigation into NECC, the company that manufactured the contaminated injectable steroids;

3)      Investigated the details of the U.S. Department of Defense’s sole-source contract with Ameridose, a compounding center which is operated by NECC’s leadership team;

4)      Investigated the details of the U.S Department of Veterans Affairs’ large scale purchases of drugs and related goods from Ameridose; and

5)      Sent letters with the HELP Committee to the FDA, the Massachussetts Board of Pharmacy, and NECC for further information

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