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Subscribe to RSSWASHINGTON, D.C. -- More than a decade ago, federal health inspectors wanted to shut down the pharmacy linked to a recent deadly meningitis outbreak until it cleaned up its operations, according to congressional investigators.
Nearly 440 people have been sickened by contaminated steroid shots distributed by New England Compounding Center, and at least 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention. That has put the Framingham, Mass., pharmacy at the center of congressional scrutiny and calls for greater regulation of compounding pharmacies, which make individualized medications for patients and have long operated in a legal gray area between state and federal laws.
The House Energy and Commerce Committee released a detailed history of NECC's regulatory troubles on Monday, ahead of a meeting Wednesday meeting to examine how the outbreak could have been prevented. The 25-page report summarizes and quotes from FDA and state inspection reports and internal memos, though the committee declined to release the original documents.
The report shows that after numerous complaints over years, Food and Drug Administration officials in 2002 suggested that the compounding pharmacy be "prohibited from manufacturing" until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.
The congressional report shows that in 2003 the FDA considered the company a pharmacy. That's significant because since the outbreak came to light in late September, public health officials have charged that NECC was operating more as a manufacturer than a pharmacy, shipping thousands of doses of drugs to all 50 states instead of just prescribed doses to individual patients. Manufacturers are regulated by the FDA and are subject to stricter quality standards than pharmacies.
The report offers the most detailed account yet of the numerous regulatory complaints against the pharmacy, which nearly date back to its founding in 1998. Less than a year later, the company was cited by the state pharmacy board for providing doctors with blank prescription pads with NECC's information. Such promotional items are illegal in Massachusetts and the pharmacy's owner and director, Barry Cadden, received an informal reprimand, according to documents summarized by the committee.
Cadden was subject to several other complaints involving unprofessional conduct in coming years, but came to the FDA's attention in 2002. Here are some key events from the report highlighting the company's early troubles with state and federal authorities:
- In March of 2002 the FDA began investigating reports that five patients had become dizzy and short of breath after receiving NECC's compounded betamethasone repository injection, a steroid used to treat joint pain and arthritis that's different from the one linked to the current meningitis outbreak.
FDA inspectors visited NECC on April 9 and said Cadden was initially cooperative in turning over records about production of the drug. But during a second day of inspections, Cadden told officials "that he was no longer willing to provide us with any additional records," according to an FDA report cited by congressional investigators. The inspectors ultimately issued a report citing NECC for poor sterility and record-keeping practices but said that "this FDA investigation could not proceed to any definitive resolution," because of "problems/barriers that were encountered throughout the inspection."
- In October of 2002, the agency received new reports that two patients at a Rochester, New York hospital who came down with symptoms of bacterial meningitis after receiving a different NECC injection. The steroid, methylprednisolone acetate, is the same injectable linked to the current outbreak and is typically is used to treat back pain. Both patients were treated with antibiotics and eventually recovered, according to FDA documents cited by the committee.
When officials from the FDA and Massachusetts Board of Pharmacy visited NECC later in the month, Cadden said vials of the steroid returned by the hospital had tested negative for bacterial contamination. But when FDA scientists tested samples of the drug collected in New York they found bacterial contamination in 4 out of 14 vials sampled. It is not entirely clear whether FDA tested the same lot shipped to the Rochester hospital.
- At a February 2003 meeting between state and federal officials, FDA staff emphasized "the potential for serious public consequences if NECC's compounding practices, in particular those relating to sterile products, are not improved." The agency issued a list of problems uncovered in its inspection to NECC, including a failure to verify if sterile drugs met safety standards.
But the agency decided to let Massachusetts officials take the lead in regulating the company, since pharmacies are typically regulated at the state level. It was decided that "the state would be in a better position to gain compliance or take regulatory action against NECC as necessary," according to a summary of the meeting quoted by investigators.
The FDA recommended the state subject NECC to a consent agreement, which would require the company to pass certain quality tests and assurances to continue operating. But congressional investigators say Massachusetts Board of Pharmacy did not take any action until "well over a year later."
- In October 2004, the board sent a proposed consent agreement to Cadden, which would have included a formal reprimand and a three-year probationary period for the company's registration. The case ended without disciplinary action as part of a different consent agreement reached with the board in 2006.
FDA Commissioner Margaret Hamburg and Massachusetts Department of Public Health interim commissioner Lauren Smith are scheduled to testify at Wednesday's hearing.
According to the congressional report, lawmakers plan to ask the witnesses whether the FDA and state pharmacy board acted appropriately. Cadden is also scheduled to appear at the hearing, after lawmakers issued a subpoena to compel him to attend.
The NECC has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license. The pharmacy has recalled all the products it makes, including 17,700 single-dose vials of a steroid that tested positive for the fungus tied to the outbreak.
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i wonder if the FDA ever contacted the governor of Mass. in 2003 or 2004 for assistance to shut down this place?
Gee, and who was the governor during that time? ;) Lest we forget: teaparty right wingers want LESS regulation...... and further advocate for more state sovereignty.... "Too much government interference" they say. . . . What part of: Government doesn't have enough inspectors NOW - - - don't they understand? .... and RW teaparty, spawned by the 1% want to deregulate and cut MORE?
This is a powerful argument for more federal oversight and a greater budget for enforcement efforts.
In 2002, the FDA was controlled by the Bush Administration, which always sought to limit federal power in investigative and regulatory agencies. In all likelihood, Bush policies are responsible for the FDA's referral to local authorities at the state level.
This story is a perfect example of why some politicians are so adamantly in favor of State control. Human life is nowhere near as important as the opportunity for state pols to do favors for local money.
It goes right to the core of our governance problems, in an even more serious (life and death) way than the incredibly screwed up state control of elections, but, of course, will get only one one hundredth the media coverage of Generals Boffing Hottie Sluts.
Why do some trolls have to try and turn everything into a political issue. This has nothing to do with political parties, it has to do with the Massachusetts Pharmacy Board and the FDA failing to enforce their own regulations. We do not need more regulation, what we need is better enforcement of the regulations we already have. There was clear indication back in 2002 that NECC was operating in a manner that was beyond the scope of its license as a compounding pharmacy. Compounding pharmacies are only supposed to make up drugs in response to specific prescriptions or specific orders from individual health care providers. They are not supposed to be manufacturing drugs in large quantities for wholesale distribution, which is what NECC as doing. Since, as a compounding pharmacy, they were operating under a state license the Massachusetts Pharmacy Board should have revoked their license back in 2002 and shut them down. This entire affair, and the deaths and illnesses that have occurred could have been prevented if the state regulators had simply done their job ten years ago. There is no need for additional regulations and most compounding pharmacies operate with the scope of their licenses. They make up medications in response to a doctor's prescription for an individual patient, which is exactly what they are licensed to do. To burden them with additional, unneeded regulations would be wrong and likely damaging to their businesses. Their is no reason for an entire industry to suffer because of one rogue company and the failure of a state regulator to do their job. The Massachusetts Pharmacy Board should be found complicit in every death and illness that resulted from the tainted products coming out of NECC because of their complete failure to meet their responsibilities and obligations.
It has EVERYTHING to do with politics, JD.
The Bush administrations main goal was to deconstruct regulatory agencies that "got in the way" of business.
So the agencies got out of the way - and people died. Lots of them.
Too bad we can't hold those who set this train wreck in motion accountable.
Oh, wait - we started. See last Tuesday's election.
By the looks of your past posts, Everything is a political post. If my toast burns in the toaster in the morning should I be calling my local rep? Really? Grow up. Life is not wrapped around politics...
Mr. Frost, how many people did your burnt toast kill? Nope, not everything is a political post. But deregulation of industries that can kill for a profit is definitely political. Or are you still working on your burnt toast?
Confusion over the FDA's jurisdiction over compounding pharmacies happened because the Supreme Court threw out part of the oversight legislation in 2003. And the Republican Congress in charge at the time refused to write new authorization for FDA control.
Sound familiar?
Read more: http://www.foxnews.com/health/2012/10/16/how-compounding-pharmacies-rallied-patients-to-fight-regulation/#ixzz29VONkDyl
Kind of ironic that the GOP is calling for investigations of the FDA over this, when they were the reason it wasn't controlled in the first place.
RealAmericansFirst is spot on with that. From the beginning the Cheney/Bush administration realized they could not simply do away with these various regulatory and other federal agencies. So they simply gave over the administration of these agencies to the industries they supposedly "regulated". Mine safety? Administered by representatives of the mine owners. EPA? Manned by lobbyists from the polluting industries. The SEC? Let Wall Street regulate itself. They know more about the financial world than government bureaucrats. Bernie Madoff? Who cares? He's a job creator.What could go wrong? FAA? The marketing arm for the US airline industry. OSHA? Gut their funding, put manufacturers lobbyists and insurance companies in charge. And on and on and on...The republikans, if given the chance, would gut all government regulations governing American business activity and replace them with government regulations governing the American female's reproductive decisions.
So there's the trade off America, are you all ready for that????
Whether or not this industry needs more regulations is something I can't really speak too, but very clearly we need to beef up enforcement. It is pretty obvious that regulation did catch what was happening, but the problem is that it didn't shut them down. I'd be almost OK with State's rights being applied as long as anything these guys produced, stayed within the borders of the State. But this company shipped its tainted products to all 50 States. The irony is that I would tend to trust Massachusetts far more than I would trust a whole lot of other States including my own!
They should throw the book at the owners of this company and that ought to include hundreds of charges of involuntary manslaughter. If this isn't a shining example of some business owners needing to be thrown in jail, I don't know what is. If this happened in China and was made public, these guys would be facing a firing squad. It is time we made an example of some of these greed driven people who obviously have little regard for anything but making a profit. The fact that these guys were warned before and yet similar problems still existed, just makes it even worse. I agree too that some State officials ought to be facing prosecution too.
This whole business of State's rights just goes way too far when their decisions and how they exercise their "rights" has impacts on other citizens. This is political if for nothing else than this very reason. It is political office holders who control the applications of regulations. Therefore those politicians and the citizens who elected them need to be held accountable too. If you want the rights, you assume the accountability. In a case such as this I would be perfectly fine with the courts finding every citizen of Massachusetts accountable and issuing fine against them to pay restitution to those outside their State who were impacted. If the people of a State want to decide to deviate from Federal standards, they'd better be ready to pay the consequences when some impact crosses its borders. Want less regulation on stuff like pollution? OK but when that air or water leaves your State and goes into another, you are subject to a lawsuit and accountable for any damages. Want to control your own destiny? Fine but when it impacts anybody else's destiny, you're accounatble.
The FDA could have shut down the plant in a minute; by simply banning them from any interstate shipments; all the regulatory agency's, Fed and State, sat on their hands; once the 4 vials that were tested positive(4 of 14), they had the authority to prevent them from shipment in commerce; this was a preventable tradgey, and no one did anything about it.
saxon,
100% correct. I've been saying that existing regulations are good enough. The problem, which seems to be an epidemic, is non-enforcement. It isn't like the FDA didn't know something was wrong. It isn't like the state didn't know something was wrong. That's half of regulations there, checking in on industry to make sure they're doing their job. Both agnecies confirmed that this industry was NOT doing their job. The second half of regulations is the framework to take corrective action. There's the rub. What needs to change are mandatory corrective actions, no special pleading, no special deals. You do X it has outcome Y.
As far as I know, none. It's just burnt toast. Ya know? Scrape off the burnt part, butter the rest.
Not everything is political.... It really isnt. Put down the political agenda, and work for a better America. :)
Pontius Pilate would be proud.
So the US invades other countries and hangs their dictators when they don't cooperate with inspectors, but that same govenment has to slink off with its tail between its legs when the owner of a dirty pharmacy won't play ball? Is that what I'm hearing?
Inject the son of a bitch with his own tainted crap.
The Federal agency let the state agency handle it. Its the popular thing, just not the right thing.
Romney was then governor of MA. Fail.
I was right at the point when I was going to get one of those shots. I have grade 3 spondylolithesis and am in constant pain. My wife was bugging me, but I held off because I don't trust the health care racket. My prayers go out to those who, like myself, have this or similar problems and DID get these injections. What an evil shame, and what an indictment of our medical system.
Not only the patients are the victims but the doctors who trusted the company to deliver a good product. Many of them had long-term relationships with their patients and cared about them as well as taking care of their problems. Some of them were friends, weekend golf buddies, etc. I can imagine how they must feel now. If you have to look over your shoulder when you are acting in good faith, you are really entering a new world.
So, who PAID the FDA to look the other way and not close the pharmacy? Mitt Romney?
There is more clout in political pressure than in 'money'
The FDA ddoes not regulate compounding pharmacies so they didn't look the other way they just had no authority to close it down. The state must do that. The real question is why the Massachusetts didn't shut them down.
If I remember, Was it not the republicans whining about too nuch Federal intervention?? sounds like the FDA was trying to turn it over to the state (ran by Romney) for intervention. Did'nt work did it.
And this is Mitt Romney's quote, "Every time you have an occasion to take something from the federal government and send it back to the states, that's the right direction. And if you can go even further, and send it back to the private sector, that's even better."
Imagine if the regulatory agencies were profit centered private companies.
If those secessionist clowns ever got their way, you can absolutely count on just such an arrangement in their Teabagistan utopia. Plus a high body count every time one of those privatizes regulators screwed up...
This is all well and good, but I am still asking why the managers of this facility have not yet been charged with manslaughter?
A standard neocon position is "When is profit bad?". I believe this is the answer that that rhetorical question.
Profit in itself is never bad---it depends how you obtain it!!!!
Gee, aren't we happy with the outome of Gov. Mitt Ronmey's 'regilstion' in Mass? There are at least 32 families who would vote for more strict regulation.
Consumers even though they are under the care of medical doctors and while we are in an advancing technical society need to be assured that each step of the way that know measures for safety are employed and are verifiable.
We can either reinvent the wheel by experimenting with sanitary handling, unclean facilities, sloppy practices that predate modern medicine, or we can use the advancing technology to eliminated these hazards as far as possible.
We are obviously between one level and a more advanced level, where the question should be what is holding this technology back?
From various perspectives we can isolate the cause from effects. The effects of the medical suppliers and industry lobbying Congress and Administrations to under fund and ruin inspection agencies and reduce reporting requirements, fits perfectly with high level business notions of lowering costs and maximizing profits, as well as the entrenched mistaken notion from years ago that deregulation is always good. This 'business sense' adds to the limits on corporate liability, using the LLC escape mechanism, as well as the two hundred years old limits in liability of corporate stockholders. These 'business' rules, would allow xenografted goat testicles to address erectile dysfunction, just because a business could be founded on patent medicine does mean that public should be exposed to products better left in medieval times. As far a clean, heath practices we could be better served, by prejudicial liability on any and all who would allow this Congress/Lobby/Business facility to continue.
Any investigation on heath products companies has to consider development cost, certifications costs on their products all that contribute to total cost being high. But the 'business' heads are not satisfied with a factor of 5 markups, when 10 or 100 are possible. New products may be well worth it but for every justifiable breakthrough, there are 99 also ran's for old ancient and venerable techniques that Doctors are going to sued for using. This mixture of good/bad/worse cannot price products appropriately or improve current practice of gouging the heath care industry for expensive equipment that would work better and not cost so much, except for the licensing, patent, copyright profit cycle.
The reduction of modern instrumentation, medical and otherwise, being made available by iPhone applications is rapidly changing the landscape of communications. That same innovation needs to be brought back into the lab, as test equipment, cheap, effective and wide spread communicating contamination situations.
Things need be done, get Congressional corruption separated from regulatory authority, get business corruption away from regulatory authority, delegate regulatory and properly fund. Make it clear that if you are not going to understand and follow standards and regulations, and harm comes to the public, that it is not just the business that is closed, that is the owns and managers that are behind bars and held personally liable for corrupting the system.
The biggest thing to change is how the workforce understands regulations; the current hostile business management approach has to replace by the 'this is how we do things, why we do things, how doing things this way works and how it save the company.'
It is not odd that when I learned of a rule or regulation, I would understand the cost, the benefit and just roll them into the standard operating procedures, build them automatically into day to day operations, and make it benefit, the process, the product and the company. I am always appalled at how easily the get out of whack, and but the fact that bad business habits and bad business attitudes are costly to the whole enterprise. CEO business thinking the United States, is disaster, better addressed with contaminated medical injections?
You certainly know how to obfuscate the discussion!!!
The FDA, run by an anti-regulatory republican administration (Bush II) punted to the state of Massachusetts run by an anti-regulatory administration (Romney) that dropped the ball. Before drug regulation, people routinely died from drugs that were supposed to cure them. This latest tragedy, like the financial meltdown, would never have happened had Progressive Era/New Deal regulations stayed in place.
Mitt Romney was Governor there from 2003 to 2007.
George Bush was President at that time.
Lets hear the truth!!!---was Romney instrumental in keeping it open???-------we have a right to know!!!
Oh, come on-----we need less regulation, that's obvious!!!
It reminds me of a partner I once had who objected to me hiring an attorney when we arranged a venture together----"I'm an honest man" said he------I agreed that he was---but I said the lawyer was involved to "keep him honest!"---that is what regulation is all about!!
I once had a partner that advocated the same, and the best thing I ever did was walk away.
"The love of money is the root of all evil."
I've witnessed many of good people brought down because they cannot self regulate.
Regulations go a long way towards keeping honest men honest.
Dear Disabled voter, please read your bible. It's the love of money is the root of all sorts or kinds of evil. Not ALL evil.
Why? So this can happen more frequently??????
Anton - Read my post! That's what it says.
What part of ALL would you suggest that God was wrong about?
"Every time you have an occasion to take something from the federal government and send it back to the states, that's the right direction. And if you can go even further, and send it back to the private sector, that's even better..."
Or maybe not.
What do you do with your kids?----do you let them regulate themselves or do you regulate them??
Do you teach yours to read better than yourself?
As our great republican president Ronald Reagan once said "we need to get the government monkees off the backs of the people" business can regulate itself without new regulations hindering them from making money.
Making money on the blood of others. Republicans need to use that as their motto.
Or "profits ahead of people," Randy...
Its funny how some folks want less govt yet when something like this or Sandy occur they yell their head off complaining about the lack of govt.
square dude, you've broken the code! It's called "carping for the sake of carping"!
The stupidity and/or naivete of most Americans never ceases to amaze me. It's like"I'm watching DWTS and all those other reality shows, but I'm an expert on how this country functions.", but not a clue.
the owners and heads of that company should be prosecuted for murder.these companys now a days look to more and more profit how much is enough
Although I self-identify as a libertarian more than any other political philosophy, examples like this one illustrate why a true laissez-faire economic system can never work. Sadly, people cannot be relied upon to behave in an ethical manner.
The regulators have been stupid. Surprising? Not at all, they're government employees.
Not stupid, weak.
I'll go with both.
Weak because your right-wing overlords insisted on "starving the beast" so that the agencies couldn't do the job they were set up to do. That way, when the agencies inevitably failed because of that lack of strength, the lemming (like someone on this string) could imply that government doesn't work. So tell me, how well does doing Grover's work pay lately, hmm?...
I'm not doing Grover's work. Read my post up higher; you clearly haven't yet.
The argument for States Rights falls flat on it's face, when State regulators tell the FDA that the Manufacturer is really a Pharmacy. If the issue impacts others beyond the States boundaries, States rights should go out the window.
Just proves that the time has come to suscede from the Union our government cant do anyting without people being paid off - time to consolidate
Good bye. Don't apply for aid.
But I would suggest that you learn how to spell, Barry, or is spelling optional in your hoped-for Teabagistan?...
You can either stay here and try to make it better, or leave. Don't let the door hit you on your way out.
maybe they were running for office on the platform "Safety kills jobs". What kind of a person would knowing work or supervise a pharmacy that is obviously contaminated without blowing the whistle? I don't understand how someone could knowingly put others at risk like that!
Greed and indifference to the pain and suffering of others are the hallmarks of psychopaths, and these compounding pharmacies certainly were operated, promoted, and regulated by psychopaths . . .
And these psychopaths need to be punished to the fullest extent of the law for the betterment and enlightenment of others, which certainly needs to include such severe punishments that these compounding pharmacies and their owners and employees become textbook examples in colleges and universities to help professors teach pharmacy students the indisputable fact that no matter how much trouble and work it might appear to be to do compounding accurately, reliably, and safely, it is without doubt less trouble and work than not doing it, where if doing everything the correct way is an insufficient incentive for the less ethical and moral students, then not being subject to the punishments for doing sloppy unsafe work will be sufficient a incentive, really . . .
Really! :-o
"The report shows that after numerous complaints over years, Food and Drug Administration officials in 2002 suggested that the compounding pharmacy be "prohibited from manufacturing" until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections."
I'm glad the bottom line...I mean, jobs, were put ahead of the safety of the consumer. The products were preservative free...if they'd put in antibiotics + antifungals nobody would ever know of the atrocious manufacturing conditions at NECC.
I might feel more comfortable with hospitals doing their own compounding in house...eliminate a crazy potentially untrustworthy middleman.
Aaaah, but you're just a lazy mooching 47% commie... /sarc
Perfect, regulators bargained the lives of everyone affected by these crooks, and no one ever probably set foot inside their mold, birdpoop, & insect infested facilty. Typical of $ over human life. Figures. Compounding, who needs it, get the lazy MD's off their butts and have them mix whatever drugs they feel their patients desperatly need. Maybe they won't need it that desperatly after all.
Regardless of who was governor and who was President the FDA had the power to shut them down each time and chose not to.... Not everything goes through executive channels. Isn't that what Obama said about Bengahzi........ Fast and Furious..... ETC. I see, its only okay if it happen on the Dems. watch... Got it.
Well, you got your obligatory Obama sliming into an entirely unrelated topic, I see. Go get your Koch-ie, troll...
ak, it's nice to see how you're obsessing about Obama.
May he haunt your dreams for the next four years!
I had a steroid injected into my carpal tunnel that was a different steroid but made by the same company. My doctor sent me a letter to follow up with my primary care doctor. She doesn't think I have an infection because my wrist isn't red or hot. However, I've been unable to make a fist because my fingers are so swollen since the injection. My ortho doctor wants to do surgery, but how can I trust anything injected into me? I think I'll just continue with the splint and live with it.
The medication in question caused problems because the entire batch was contaminated.
If the batch your injection came from was contaminated, you would have heard about it by now.