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Susan Walsh / AP
Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg testifies Wednesday, Nov. 14, 2012, before the House Energy subcommittee on Oversight and Investigations hearing on the fungal meningitis outbreak. Without better legislation, Hamburg says, more such outbreaks could happen.
Food and Drug Administration officials know little about compounding pharmacies in the U.S., including who all is making drugs and medical supplies, how much they are making and where they are sending it, the agency's commissioner said Thursday.
And, says FDA's Dr. Margaret Hamburg, it’s entirely likely there could be another outbreak of infections like the spread of fungal meningitis caused by contaminated pain injections that has killed 32 people and sickened more than 460.
Even while repeated inspections showed the pharmacy blamed for making and distributing the contaminated drugs was operating with dirty conditions and wasn’t following the rules, regulators at FDA were arguing about how much they could actually do to shut them down, Hamburg told a Senate hearing.
Hamburg and Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, faced a second day of questioning in Congress about the outbreak. Reports by the House and Senate subcommittees holding the hearings paint a picture of a mixed record, with some states, such as Tennessee and Colorado, acting promptly and others, such as Massachusetts, doing little. And they also point a finger at the FDA.
“While the quick work of the public health community has led to early identification and treatment of many cases of meningitis, and reduced the fatalities resulting from the administration of the contaminated methylprednisolone, the committee’s investigation demonstrates that this crisis should have, and could have, been avoided entirely,” the Senate Health, Education, Labor and Pensions (HELP) committee report reads.
At issue is how the New England Compounding Center could have continued to make and distribute contaminated drugs that were given to at least 14,000 unsuspecting patients, even while regulators had their eyes on the company.
"It was obvious they were acting illegally," said said David Miller, chief executive of the International Academy of Compounding Pharmacy in Missouri City, Tex. "The Massachusetts Board of Pharmacy knew this was going on, FDA knew they were doing this 10 years ago and still did nothing to stop it."
Hamburg said it could happen again.
“For more than a decade there have been problems in this area and there will be more problems unless we really work together,” she told the subcommittee’s hearing. “I just think we can do better.”
Hamburg has been pressing for federal legislation to make clear what the FDA can do to regulate pharmacies. Some members of Congress have said at two days of hearings that they are not sure FDA needs more power but rather needs to use the powers it already has.
Sen. Pat Roberts, R-Kan., read out a list of state and federal actions against the New England Compounding Center dating back to 2002, none of which closed it down. Regulators say NECC was acting as a large-scale manufacturer, distributing tens of thousands of medical products to 45 states, while it was licensed to be a compounding pharmacy. Compounding pharmacies are supposed to mix products to order on the basis of individual prescriptions.
“In March 2002, a prescribing doctor reported to the FDA that as many as five patients became ill following an epidural injection of NECC-produced betamethasone repositories,” the Senate HELP committee report reads. Betamethasone is a steroid that can be used to treat pain like methylprednisolone, the main drug involved in the current outbreak.
“He reported the illnesses to the FDA, alerted NECC about the issue, and returned unused doses to NECC without taking samples. However, when the FDA arrived to inspect NECC on April 9, 2002, there were no records for the drugs in question.” No disciplinary action followed.
Two more patients got sick in August with meningitis-like symptoms, linked to methylprednisolone made by NECC, again reported to FDA.
The strongest action FDA ever took against NECC, before it raided the facility in October of this year, was a warning letter in 2006 over a different issue. “Finally, in 2006, a warning letter!” Roberts shouted. “Finally, we get something done!”
But FDA never acted on that warning, either. “Holy mackerel,” Roberts said. “What am I missing here?”
“I wasn’t at the agency at the time,” Hamburg said. “I know there was a lot of internal debate about whether and how to proceed. That’s why it was slow, because there was ambiguity in the law. I think that we all wish we had done more.”
Hamburg said she is trying to find out how many companies like NECC there are, making products in mass quantities.
“We do not know the universe of compounding pharmacies,” she told the hearing. “I do think that we should know,” she added. “We are beginning to reach out to our colleagues on the state level.”
Currently, the FDA regulates drug manufacturers, while state boards regulate pharmacies, including compounding pharmacies. FDA has mixed authority in different parts of the country, and another problem is the changing nature of the industry, Hamburg said.
“The problem is that it is not a clear distinction between what is a compounder and what is a manufacturer, either in law or in practice, and the industry is evolving,” she said. “We have tried to use the authority that we have, but it’s reactive.”
And FDA doesn’t even know where to begin looking harder. “We think there are about 7,500 pharmacies doing so-called advanced compounding, then about 3,000 doing sterile processing,” Hamburg said.
Hamburg said there is a need for federal regulations that set a framework for states to follow. “Some states are very strong in terms of their boards of pharmacy, others are weaker,” she said. “We have authority but it is limited and unclear and contested.”
Miller disputed this. “The difference between NECC and a compounding pharmacy is they weren’t filling prescriptions. They were bulk manufacturing and selling,” Miller told the committee. “By all current indications, the operations of NECC were clearly outside the scope of the state’s licensure requirements and their license should have been pulled long ago.”
Sen. Tom Harkin, D-Iowa, who chairs the panel, said the committee was sending a letter to every state board of pharmacy asking them to detail companies acting as compounding pharmacies.
“This committee will forge ahead in developing legislation,” Harkin said. He said he hoped a draft could be ready by early next year.
Harkin also said agencies like FDA and the Centers for Disease Control and Prevention need to be funded and staffed well so they can protect public health. “This comes down to resources,” Harkin added. “We continually ask the Food and Drug Administration to do more and more and more.”
One person who could have answered questions wasn't there. Barry Cadden, president of NECC, did not accept the committee's invitation to appear. On Wednesday he refused to testify to a House panel, involking his Fifth Amendment right not to speak.
Related stories:
Pharmacy owner escapes testifying about fungal meningitis outbreak
Fungal meningitis victim: "It's tortuous"
State pharmacy board chief fired
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People with back pain should learn to live with it then.
I did. I walk around a lot with what feels like a hot knife stuck in my back. It sucks to have chronic back pain, but my experience with the injections wasn't very good either. After trying several doctors over the years, I quit having the injections. I can usually tolerate it during the day OK. It's when I have pain at bedtime and nothing to concentrate on to keep the pain at bay that I have problems. I have a pain pill prescription now and will probably have one for a while longer. I hate taking those too since they give me nightmares and I end up waking up in the morning feeling like I haven't slept at all so I only take one when I just can't stand it any longer. Things are slowly getting better though. It's been over a year since my last pain pill prescription was filled.
A lot of things in life suck. You fix what you can and deal with what you have to. Else you may was well jump off a bridge.
I also should admit here that I have a fairly high threshold for pain and realize that some people would be miserable with the level of pain I've grown used to.
The last thing we need is more regulations. What happened here was a clear failure on the part of the pharmacy board in Massachusetts to do its job and enforce the exiting regulations. It was abundantly clear over a decade ago that NECC was operating in a manner that was beyond the scope of their license. They should have been immediately shut down and their license revoked. Instead, the state regulators did nothing. They had it within their power under existing law to put a stop to what was going on and failed miserably. In addition to NECC, the Massachusetts pharmacy board should be held criminally liable for what happened. Along with the authority they are given must come the responsibility to use that authority to protect the public. They did not do this. Additional regulations will do nothing to prevent a recurrence of this same tragedy so long as worthless regulators fail to use the power and authority they have to stop these out of control companies. Regulations without enforcement accomplish nothing as far as protecting the public. Until we start holding these regulators responsible for their failures to act, things will not get better. The Massachusetts pharmacy boards failure to shut down NECC despite their knowledge that NECC was operating illegally constitutes criminal negligence on their part and their must be action taken against those responsible for this failure. This was not the FDAs fault as it is very clear that pharmacies, including compounding pharmacies are regulated by the states, not the federal government.
Well, JS in SD, less is better, at least until it affects you directly. The Feds need the ability to declare defacto status and apply the appropriate manufacturer regulations when the business is operating as a manudacturer. Charging the former Massachusetts chief pharmacy regulator with manslaughter would help but it will never happen. We have a system of laws, not a system of justice. I hope you have the opportunity to experience first hand the results of what you advocate, that would be justice.
People with back pain should what? It is important to note that these articles are not accurate in several ways, but one very specific way that need to be corrected. The drugs in question right now are for treating INFLAMMATION not pain. When the swelling goes down the pain follows. The issue with allowing the swelling to continue is that it will undoubtedly cause more damage eventually and leave the person unable to do what they have to. The quality of life is terrible, and it eventually costs everyone way more than treating the problem. The real issue here is that it is imperative that the suspensions are sterile. Many compounding pharmacies choose not to do injectables for this reason - most labs cannot maintain fully sterile environment. The Mass lab should have made the same decision.
Sees Thru Gloss: How about if you take the top part of your spine, fracture it at L5, and move it an inch forward so that your main spinal nerves crease? Let me hear your opinion then. I assure you you have no idea what you are talking about. No idea whatsoever.
......says the person who's obviously never had to live with chronic back pain.
I manage my back pain with oxycodone. This whole thing would not have happened if it wasn't for the Republican support for Zombie Capitalism. Government regulations are onerous and to be avoided at all costs, or so they say. Better to have a pile of bodies that to restrain any business from wringing every last penny of profit out of every transaction. All industries need to pay a "oversight tax" to pay for their regulation. When they screw up, the tax and regulation should go up. Profit sharing ought to be the law too.
I manage my back pain without dope. Core exercises and pain tolerance. My wife had me inches away from steroid injections. I pray for those victims that are poisoned for profit. It could have been me, too.
FDA approves the sale of cigarettes to white trash, smoking must be healthy!
It is amazing that FDA requires new laws to oversee companies such as New England Compounding Company (NECC). Just because a company uses the word “compounding” in their name, does not mean they are compounders under the regulations. I wonder if some company would use the word British in their name, FDA would probably think the British Minister of Health should have taken action, even if that company was manufacturing and marketing pharmaceutical products in the United States. FDA is or at least should be more on the ball than that.
FDA knew several years ago that NECC was not a compounder, but a full scale manufacturing operation. FDA should have used its authority to regulate the manufacturer of injectable products to deal with NECC well before this meningitis outbreak. FDA does have authority to deal with manufacturing of injectable products, as well as other pharmaceutical manufacturing. In fact, FDA has placed injectable products at the peak of its risk based enforcement initiative.
FDA says they don’t even know how many compounders there are. I think if they asked pharmaceutical companies, that many could tell FDA. Some compounders even compete with those true pharmaceutical companies. Better yet, States Board of Pharmacy could help them understand, and probably which ones are larger manufactures. But wait FDA even inspected NECC, however FDA they saying they couldn’t tell NECC was a manufacture and not a compounder – Unbelievable!
This is truly a devastating lack of leadership at FDA. However, FDA always cries they don’t have the authority or don’t have the resources when something like this occurs, instead of using the regulations they already have. I wonder who is to blame here?
Lawyers. Let's say the FDA issues a "shutdown" order. The company immediately files an appeal in court and keeps operating. This jerkoff Cadden should spend the rest of his life in prison and forfeit all of his assets to the victims.
Even if the FDA didn't have the statutory power to regulate this compounding business they still could have blown the damn whistle and gotten them stopped!!!! FDA heads should roll over this incident!!!!
If you are receiving treatment at a pain clinic and ask them what drugs are used in the treatment and where they get them, most probably won't tell you their suppliers name or policies. Too many doctors act as though you don't have the right or reason to question them. If the FDA is supposed to protect the citizens against unsafe methods and products, but do nothing when it finds violations, you have to ask yourself; what are our tax dollars being used for besides studies and committees? Certainly not results, or common sense. The quest for larger profits seems to be breeding an atmosphere where cutting corners and corruption are the standard,and that puts us all at risk.