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BOSTON - The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering serious issues at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents showed.
The New England Compounding Center (NECC) chastised the FDA for taking so long, telling the agency its response time was nearly 18 months longer than the FDA's average response, according to letters released by a Freedom of Information Act request from Reuters.
Since the FDA's December 2006 warning letter to NECC, both sides have come under intense scrutiny. State and federal regulators, including the FDA, are being asked why they didn't move sooner against NECC, given a long history of concerns about the family-owned pharmacy's operations.
The Centers for Disease Control and Prevention said 34 people have died and 490 have been injured after Framingham, Massachusetts-based NECC shipped thousands of fungus-tainted vials of methylprednisolone acetate to medical facilities throughout the United States. The steroid was typically used to ease back pain.
On Tuesday, defense lawyers for NECC's owners told a U.S. District Judge in Boston there was nothing to show they had a direct hand in the cause of the meningitis outbreak.
But the newly released documents reveal a combative side to NECC chief pharmacist, Barry Cadden, and his brother-in-law, Greg Conigliaro, the recycling entrepreneur who helped him launch the specialty pharmacy.
Inspectors said Conigliaro became indignant during a September 2004 inspection by the FDA and Massachusetts regulators, documents showed. At one point, Cadden told his brother-in-law, "Don't answer any more questions!" according to a 2005 FDA memorandum.
The inspectors had concerns about how NECC was compounding and dispensing Trypan Blue, a dye sometimes used in eye surgery. Inspectors also expressed concern about how NECC was repackaging Avastin, highlighting the threat of contamination when the pharmacy opened sterile containers of the cancer drug.
The FDA's eventual warning letter to NECC in December 2006 was based on an inspection that began in September 2004 and ended on January 19, 2005, according to the documents.
"This prolonged gap between inspection and warning letters does not comply with FDA's procedures," Cadden, NECC's chief pharmacist, wrote in a January 5, 2007 letter to FDA compliance officer Ann Simoneau.
In follow-up correspondence, FDA officials apologized for the "significant delay" in correspondence time between the inspection and the warning letter. While the FDA conceded the gap was unusual, it in no way diminished the regulator's "serious concerns" about NECC's pharmacy operations, documents showed.
Related stories:
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Fungal meningitis victim: "It's tortuous"
State pharmacy board chief fired
Bacteria, fungi found in pharmacy's drugs
The man in charge of the specialty pharmacy tied to the deadly meningitis outbreak was on Capitol Hill today. He faced questions about what happened to cause 32-deaths and 461-illnesses from tainted steroid shots. One big question: how the company with a checkered history stayed in business despite years of red flags. Here's NBC Senior Investigative Correspondent Lisa Myers.
Leave a Comment:
FDA approves the sale of cigarettes to white trash, smoking must be healthy!
and that is related to this article in what way?
bobs ur uncle
You are a Racist Butt Head
something is very wrong here, there must have been political pressuare behind the scenes to allow them to stay open.
684 days!!! And many want the government to run health care! LOL!!!
Twinkies twinkies twinkies!!!
This happened between 2004 and 2006 -- during the Republican Bush administration -- an administration that was hostile to government regulation and oversight, and determined to make any and every attempt at regulation fail.
jackalope-1429482
I knew someone would try to make this political. Blame it on Bush... Damn that is getting so Lame it is sickening
Times-Running-Out
With all due respect, Bush created a great deal of woes that we are still paying for as a nation. To sweep his legacy under the rug and pretend there is no lasting impact is sickening as well.
Now I can't comment on Jackalopes non-factual, info-deprived claim...... but I can tell you that it would not surprise me if his accusation was straight fact.
Keep blindly staring into the future without applying any historical data to your decision making processes. Maybe you can invent the wheel (again) or better yet..... run for public office.
And of coarse no accountabilty thats only for normal folk, serial killers
It is past time to clean house at the FDA and for Congress to increase the FDA funding so they can more adequately do the job they are supposed to do in all areas, eg. imported product inspection.
Times-Running-Out
To repeat an old cliché, "You are entitled to your own opinion, but you are not entitled to your own facts."
Read the article. "The FDA's eventual warning letter to NECC in December 2006 was based on an inspection that began in September 2004 and ended on January 19, 2005, according to the documents."
It did come to mind how Republicans want less regulation. They howl big government when something is tried to straighten out a mess like this but are quick to blame it on something besides a lack of regulation when it does go bad.
Same with the banking fiasco. The want to blame Freddie Mac and Fannie Mae but failed to see that the main problem was due to a gutting of the Glass-Steagall Act.
Now the Koch brothers are after the EPA because of their regulations. Why? Because it cost them money to not pollute the world.
An inspection in 2004 that raises serious concerns doesn't prompt any action until late 2006, and then just a letter! That alone should be a criminal offense. Now 34 people are dead because of negligence on the part of the owners. This is a tragedy resulting from laziness, greed, and incompetence. If we could get rid of all the leeches, parasites, and do-nothing incompetent bureaucrats in the state and federal government I believe it would solve the deficit, lower taxes, and give us all a better chance at living healthy prosperous lives.
Uh... I think some heads need to roll at the FDA. If Obama is smart, he'll make some big changes at the top of that agency.
It is far more likely that the delay was caused by the legal department than by bureaucratic inertia. Congress had curtailed the FDAs ability to enforce manufacturing standards for compounders in the late 90's (thanks GOP). And the Surpreme Court had recently invalidated parts of the law aimed at controlling the actions of compounders.
Remember, when you vote for someone who is anti government don't be surprised when they deliver ineffective government.
Heads on both side need to roll! (And many of them)
There is an article in SALON titles "Romney’s lax regulation may have fueled meningitis outbreak". Read the article to find the whole story. Thanks
Here is the link:
Link:
http://www.salon.com/2012/10/30/romneys_lax_regulation_fueled_meningitis_outbreak/
Surprised?
Lack of regulation kills people.
Sorry, GOP - that's the fact.
This is an example of corporations and lobbyists running the government.
Lack of regulation kills people ? People having accidents kill people, FDA aproved drugs kill people, etc., not regulations. Geez, no wonder Obama supporters voted for the EPA and Obama, they don't quite grasp the reality of personal responsibility.
I suppose some think that the Departement of education actually has teachers in the class teaching, or that the Argriculture department is growing food.
Well you know, the government employees and their unions have their work rules. Working too fast is prohibited.
Actually, I think it's just work in general that is prohibited.
Actually the real villain is the corporation, not the government! Why should we need government oversight? Shouldn't the marketplace take care of these types of problems. When customers realize using your product is fatal, they will take their business elsewhere and you will go bankrupt.
So Dave, we are to accept that people have to die before the market corrects itself? Really?
If only that were the case, Dave. Reality is that customers don't realize the product is fatal until it's too late. Meanwhile, corporation keeps right on manufacturing until the link is made and government steps in to shut them down.
No urgency with Government
Uh...I was joking. That was directed to people (mostly Republicans) who believe the government has no place in corporate oversight.
The FDA did not make those drugs! They came out of a corporation. Why are we complaining about the FDA and not NECC? Throw the corporate execs in jail and lose the key. Other companies will get the message and we won't need any oversight.
I guess you have to learn to joke better.
I'm sure glad that the time did not diminish their serious concerns. It makes you wonder what would have happened if their concerns were diminished?
If their concerns were less serious, they would change their name to the Federal Drug Advertising department for the drug companies.
I thought that's what FDA stood for Garrick
Yup, those serious concerns stayed intact while they did nothing to address the concerns. Is this too much govt or too little? It might be just about right if they hired enough people to do the inspections and kept the paperwork moving (fire those who don't work efficiently). Food and drug inspections have always been too few and far between.
F u**ing
D umb
A sses
Simply put - who controlled the FDA in 2005 to 2007... When you have that answer well then you will know that health care should be different sadly small minds come with small mouths.
...what?
The New England Compounding Center, responsible for the current devastating outbreak, actually wrote to chastise the FDA for taking too long to chastise it for problematic practices back in 2005?
Nervy.
Apparently the FDA findings back then weren't strongly worded enough convince the NECC to actually change its ways before something bad happened. That must be the FDA's fault too.
Sounds alot like "we're not guilty cuz you took too long to stop us"
684 Days......This is amazing that the FDA who busts other manufacturing sites for crossing out and not dating or verifying changes and issuing 483's.... They are out of control...and their priorities are so far out of line it isn't funny. This organization really needs to be revamped......
From Wikipedia, regarding the FDA and NECC:
The state, not the FDA, had oversight over NECC, though shipping out of State and manufacturing large batches of pharmaceuticals would have made them a manufacturer, and under FDA control. Legislation in 1997 would have given the FDA authority to regulate all compounding pharmacies, but that legislation was partially overturned by a 2002 Supreme Court decision.
People do not realize how incompetent and lazy the FDA really is. I worked for a major pharmaceutical company which had uncovered a pharmacy selling counterfeit drugs from Mexico. We submitted the scientific evidence to the FDA in early 1992. In 1999, I was working as a temporary laboratory worker at the FDA forensic laboratory. Before I left, I asked the head of the counterfeit drug office about the outcome of that case, just out of curosity. The FDA had just started the case in court that week and shut down the pharmacy. So, they had left the pharmacy sell counterfeit, and possibly bad, pharmaceuticals from Mexico for over eight years! They were complete idiots.
Well, let's also add one thing - the FDA did try to get in but due to state regulations - it took a person dying before the FDA had the grounds to go in with the state saying that they did not have this under control so again - research and you should find the real answer not just some info from a blog or...
It believe 684 days is about normal response time for a government entity. Be glad it was the FDA and not the VA. They are MUCH WORSE!!!
To unravel a boondoggle, you have to start at the top.
First you have to look at who the head of it is. Then, who he/she is married to. Then, who he/she is sleeping with. Then, what companies he/she is affiliated with via family and business connections.
You not only follow the money, you follow the political/business/lover connections.
WOW! That is really sad. Especially for those who have lost their lives because of a tainted drug.
I foresee alot of law suits happening.
No one resonsible for lives just trade money for a LIFE
I feel so much safer knowing the FDA is watching out for me.
they should all be fired period--plus all the new drugs coming out, either give you a heart attact , tumors, strokes or other things but they do not fix the problem--people--stop taking drugs and get well faster
Do we really need to regulate the FDA? Why can't the FDA just be eliminated, like they wanted to eliminate the EPA. Let's deregulate or eliminate all federal programs so we will have less taxes. No need for schools either, cost too much. All you really need to know is how to load, aim, and pull the trigger. Like dirty water? VOTE for t-billies
Everyon who is commenting on FDA procedures should, as noted above, take a good hard look at whose watch this oversight was under...no one on the right likes anything negative said about the bush era, but folks, THIS OVERSIGHT HAPPENED UNDER GEORGE W. BUSH'S watch!! The recent illnesses and deaths caused by compounds distributed by NECC could have been prevented had the FDA made this issue a priority. The lapse in warning time to this pharmacy was unconscionable, dangerous, and should be exposed, and people in the FDA at the time of the inspection should bear responsibility for not writing the warning in a timely manner and certainly for not following up and either effecting corrective procedures in the pharmacy supplier or shutting them down completely.
Too bad for your argument that compounders are regulated by states. That always seems to get lost by the liberal defense media.
L. Snyder
Let's talk about 'Watches'
Why is it that you even make the statement "Under Bush's Watch", Libya was under obama's watch and yet nothing is said and if it is even brought up you defend obama to the end.
Sandy happened under obama's watch and it is very clear to everyone involved that FEMA was not prepaired altho they had ample warning.
Obama 'Cut' all the red tape yet people are still trying to figure out where help is going to come from?
Blame it on Bush... Damn that is getting so Lame it is sickening.
The FDA did not make the tainted drugs! Those drugs came right out of corporate America. Do we want more government oversight of corporations? No! The fault is with the pharmacy's owners. Throw them in jail and lose the key. That will wake up other compounders so we do not see this repeated in the future.
Yea, lets stop regulating industries, and lets continue to de-fund departments so they can't regulate properly. It would seem that the conservatives plan to de-fund and under-fund our government is working pretty well, for conservatives, just not consumers. Thanks Republicans, thank you so very much for all you are doing to America.
it's a gov't agency...you expect quick results??
I'm sure glad that we got the FDA looking out for us! 2 years is a great response time. Our society is so now oriented and you can see that in the comments. We want everything right now. Warnings about deadly meningitis now!
For all of you in favor of larger, more bureaucratic, cradle to grave government-----this should be a wake up call of what we're in for with Obamacare.
So true. Without Obamacare there would have been fewer people getting those shots, therefore the death toll would have been smaller. Romney would fix that by reducing access to care, including those on Medicare. No one gets the shots -- no one dead from meningitis. Problem solved right?
ACA has nothing to do with this horror. Jarhead, I want more inspectors and more regulation (with real teeth) regarding our drug and food industries. Lack of proper "bureaucratic" over-sight resulted in to the grave for 30+ and scores deathly ill. You want less, tainted food and tainted drugs would be the norm instead the relatively rare occurrence, one time is way too much if humanely possible to prevent and oversee. Not enough salmonella, listeria, E-Coli, or staff infections to plague Americans, and we need to deregulate or underfund further, I think not.
Skyparrot and Granny. Of course you want more---of everything. Thanks for proving my point. Questions?
The FDA has a long history of ignoring the best interests of Americans in favor of corporate interests. This should come as no surprise to anyone that they gave NECC plenty of time to repair deficiencies before they made it a formal complaint.
NECC obviously had a verbal warning during the inspection phase and chose to ignore it rather than remedying the situation before it became a formal complaint. Now that they have been caught, they are whining about it rather than taking responsibility for using that time to fix the issues.
They are equally culpable
They were regulated by the state. FDA was still confused by the new law that MIGHT have given the jurisdiction but the courts were still sorting that out.
Yes. This letter came from NECC, basically blaming the FDA for not telling them soon enough that their products were dangerous and needed further safety protocols or procedures. What is that supposed to mean. These people worked here everyday. Are they saying they had no way of knowing the quality of the products they produced???? What a load of crap!!
starfox7000
That's like Ambassor Stevens BEGGING for more security and the powerers to be saying no. Then after he is attacked and killed, they sy well that person was responsible, and that person say No that person was responsible... and so on and so forth all th way down the line.
And Still NO ONE has taken responsibility. Why is that?
That's like Ambassor Stevens BEGGING for more security and the powerers to be saying no.
No, it's not like that at all. Not even a little.
There SHOULD be criminal charges filed against those at the company.
The New England Compounding Center (NECC) chastised the FDA for taking so long, telling the agency its response time was nearly 18 months longer than the FDA's average response, according to letters released by a Freedom of Information Act request from Reuters"
You people clearly did not fully read this story. Cadden, NECC's chief Pharmacist, wrote a response to the FDA as if blaming them for this Pharmacy compounding dangerous medications. LOL. Basically he is telling them that yes, I manufactured dangerous drugs and YOU should have stopped me!!! WTF!!! It is not the governments job to regulate every person in this Country. Remember, everyone is AGAINST a socialist society where the government tells you when and what to do. Just by the fact that this incompetent idiot of a Pharmacist wrote this letter is an admission of the poor work he did at the Pharmacy, as if asking the government to come in and check EVERY drug he compounded. The Government does not do that. That is why this loser WENT to Pharmacy school and got his license in the first place. As an assurance that he would follow guidelines and procedures to produce safe and effective drugs.
Him and his Brother -In - Law are despicable human beings. I am sure they opened up this business just to make money and cared very little about the quality of what they were producing. Many of you commenting here do not know how Pharmacies work in regards to what you are saying.
Pharmacist are ULTIMATELY responsible for EVERY product that leaves the Pharmacy. Whether it is compounded or prepared by a Technician or themselves. They are on the hook for the quality of it!! They must check each and every product before it is delivered or handed to the customer. They cannot blame their technicians, or the government, or anyone else for that matter if they are the Pharmacist on staff at the time. That comes with the license we get.
These two are some of the WORST Pharmacist that have come along in quite some time. But just so you are aware, medical mistakes account for more than 100K complaints at medical facilities every year.
Who cares who was the Pres... at the time... it was the Government and that's who SCREWED UP and is now in charge of our Health Care!!!!!!!!!!!!!!!!
Again Grandbubba, the GOVERNMENT has nothing to do with the quality of this medication that was produced by this Pharmacy. the PHARMACIST is responsible for this. They do not come in and stand over Pharmacist shoulders at EVERY pharmacy in America on a daily basis and tell them how to do their jobs!! Pharmacist are TRAINED and LICENSED for that specific reason. These guys were warned and knew their product was a piece of crap. They did not care about improving it until the government FORCED them to do it, plain and simple. So NO, they cannot blame the government for the quality of their product. That is THEIR responsibility!!!
Yes.. the Pharmacists are licensed... and by whom!!!!!!!!!!!!!!!!!! duh
Grandbubba what part of this do u not understand:
These guys were warned and knew their product was a piece of crap. They did not care about improving it until the government FORCED them to do it, plain and simple. So NO, they cannot blame the government for the quality of their product. That is THEIR responsibility!!!
DUH!!!!
Well that didn't take long. Instead of throwing money at them how about firing employees and getting a new batch of people in that actually want to do the job?