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Subscribe to RSSFrom a leaking ceiling in the so-called "clean room" and a bird flying through a room where sterile drugs are packed to basic problems with contamination and failures to investigate patient harm, the sister firm of the pharmacy at the heart of the deadly fungal meningitis outbreak had serious flaws in its drug-making process, federal officials said Monday.
Food and Drug Administration officials found conditions at Ameridose LLC of Westborough, Mass., so alarming during the month-long inspection between Oct. 10 and Nov. 9 that the agency urged the company to recall all of its products on Oct. 31 because there was no guarantee they were sterile.
Ameridose is co-owned by Barry Cadden, the owner of the New England Compounding Center, the pharmacy blamed for fungal meningitis infections that have sickened 438 people in 19 states and caused 32 deaths. Cadden and his brother-in-law, Gregory Conigliaro, started both firms.
The new inspection included complaints of pregnant patients hemorrhaging after being given the labor-inducing drug oxytocin made by Ameridose, and reports of patients being over-sedated on the painkiller fentanyl -- or having no effect despite being given the maximum dose of a common children’s anesthesia drug, midazolam.
“Your firm’s Quality unit failed to appropriately classify ‘patient response’ complaints as adverse events,” the FDA inspectors wrote.
The report on Ameridose described cracked and peeling walls; gaps under the clean room doors; insects and “at least one (1) bird” observed flying in the room where sterile drugs are packaged and stored. Similar inspections of NECC found filthy conditions in some rooms and both bacteria and fungus in packaged drug products made there.
No infections have been linked to Ameridose products, FDA officials said. But the possibility of serious harm is evident in the report that details 15 observations, including two that were first documented in 2008.
Those two were basic violations: failure to test finished drugs for sterility and for bacteria, as well as failure to confirm the potency of the final products.
Other problems included failure to investigate 53 instances of microbial contamination in sterile stock drugs used to make widely used injection drugs such as fentanyl and morphine, the new documents show.
In addition, firm officials also didn’t look into three instances this year when drugs failed sterility tests and they ignored 45 instances in which bacteria and mold were isolated from critical areas such as the fingers of workers preparing drugs inside sterile hoods.
Even when Ameridose officials did detect microbes, they failed to subculture them to find out precisely what they were, despite finding multiple contaminated units. Nor did they identify microbes found in the environment.
“Without knowledge of identity of microbes found during environmental monitoring, your firm lacked critical information to investigate possible root causes of sterility problems,” FDA inspectors wrote.
Ameridose officials defended the company's practices in a statement:
"While Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product, and have always been guided by Good Manufacturing Practices (GMP) referenced in federal regulations, Ameridose is committed to addressing all observations in order to enhance our existing systems. We are in the process of preparing a full response for presentation to the FDA.”
Related stories:
- More die in fungal meningitis outbreak; pharmacy chief fired
- Some infections thwart treatment in fungal meningitis outbreak
Leave a Comment:
Was Ameridose using non-domestic migrant workers or something?
That's racist and uncalled for, you ignorant tool.
See? we don't need regulations, we can always trust businesses to do the right thing.
Really, that's your response? We have regulations ... we have an FDA and a handful of other federal and state bureaucracies. That is there SOLE purpose in life is to assure safety and impose fines to violators, and they can't even do that. These agencies have been in place for many decades, BTW. I think your response is directed to the wrong people. But the company failed too, understood. And make no mistake the legal system, and regulations, and due process will insure this company is removed from the drug making business.
You beat me to it inmissouri, I'm with you-the govenment is just too big for its britches - the job killing FDA, EPA, OSHA aren't needed and just kill jobs and waste taxpayer dollars LOL.
So, wait here, and make sure i understand. The companies are clearly guilty of huge malfeasance. The FDA has been underfunded for years - all part of the Republican "starve the beast" policies.
And your logic is that it is the fault of the FDA that the companies commit these crimes??
Oh, I get it. People rob banks because we have police! So, if we get rid of police, not more bank robberies, right??
If your point is that we need to seriously look at how we allocate our enforcement resources, including changing the ways things are done as well as increasing the numbers of inspectors, then I agree. But to conclude that abuses by under-regulated companies mean we should eliminate regulations I cannot understand how you get there.
You beat me to posting the same thing.
"Less government works and the companies can figure it out..." Thankfully the public didn't fall for that line last week.
sure, STexan, this company (and other irresponsible ones) will eventually be brought to justice...after how many people die? Oh but wait, the likes of you also want Tort reform so that families of victims of malpractice find it more difficult to seek redress. And the kicker? These companies were due to be sanctioned under the administration of Governor Romney in Mass. But the Governor declined to issue the sanction, citing the company's complaint that it would depress their business. Read the Salon article on these companies if you want more details.
Willie, if that is true, why did Dubya and company outsource many of the things our military used to do for themselves (like wash their own clothes, build their own latrines and temporary bldgs., cook their own food, etc.), to contractors? Remember when the military used to be completely self-serving, as they could do what needed to be done, on their own, without contractors? Please explain, if you can.
PO---you're obviously too ignorant or dense to figure out that Inmissouri was NOT supporting your position at all!
Take away regulations, leave the "care and feeding" of the final product to the whims and greed of the owners and here's what you get---bad products that make a lot of money for the company but are so costly to the users and ultimately the rest of society.
Perhaps PO, you should make sure all your purchases for food, drugs, cosmetics, personal products, sporting goods, automobiles, gasoline and everything else you and your family use are from the unregulated side of the aisle.
Let us know what you've purchased and the smart people in the room will be sure to NOT patronize those companies---and perhaps your life and that of your family will be saved by a "regulated" medical profession that has access to regulated drugs and once you've returned to the living, will thank those folks who are the regulators, support the concept of regulation and most likely saved your useless...well, enough.
Point made.
Mortman,
PO was being sarcastic.
I work in an FDA regulated industry, I also work in Quality and Product Safety. IMHO the regulations that the FDA works under are pretty good, specially in the areas of product safety, but the regulations themselves are not enough, a well funded and staffed FDA is required to assure that the regulations are complied to. ALso required are ethical and strong willed employees of compaies who when they see things that are a threat to end user safety are allowed to take action to protect the customers. The FDA has been understaffed and underfunded for years, so has the Food Safety Division of the USDA, and OSHA.
It was telling in this article (last paragraph) where the company - AMeridose - thinks because they have had no incidents (which I doubt) that they are compliant with all the regualtions - they have a bird in their freaking building for Gods sake that isn't compliant.
@STexan (and others): actually, this is a question of lack of regulation. The FDA does not currently have authority over compounding pharmacies as they are treated differently from drug manufacturers even though they have the capacity to manufacture drugs.
If they couldn't do that, we wouldn't have heard about the ameridose problem until people started dying. While I'm sure there are procedures and policies that could be streamlined or improved, we need to be sure the FDA (and other public safety agencies) are fully funded.
here's the two realities that can exist if we fully funded/staffed agencies like the FDA:
lots of businesses would be shut down - due to failure to comply, or it would be too costly for them to comply and therefore they'd just have to close their doors anyway
OR
lots of businesses would be found to be not in regulation - and we could provide (through adequate funding) services that help them comply, help them figure out HOW to stay within the regulations and ensure they stay in business and profitable, since they are clearly to inept to do it themselves.
The 2nd option is a bit more costly from a tax perspective, but in the long run should balance itself out - in the protections to the purchasing public and by ensuring we keep the businesses in operation and people employed. EVERYONE WINS.
though, that last option will STINK like socialism to the uber capitalist conservative who thinks a company like Ameridose has every right to run a ramshackle business for max profits, despite if their products are faulty or dangerous.
I dont see it as socialism, I see it as SOCIAL-CAPITALISM
businesses prosper, people stay employed, and the public is safeguarded against shady businesses and crap products.
again, it's a win-win...for everyone except that guy who wants to cheat people out of quality and safe products for his own personal gain.
From the sheer volume of contaminated foods, clothing, and now Medicines, it is clear that the "Watch-Dog" Federal Agencies and those within each State should receive the proper funding and Revised Laws (or new Laws) in order to test and seek out those responsible for sicking and murdering our Citizens. Yes, MURDER at the Federal Level if the products crossed State Lines and MURDER at the State Level if all was Instate.
Congress should be charged with tightening or enacting new Laws to prevent this from becoming a National Standard as should State Governments do also. There is NO ACCEPTABLE reasons not to do so. BEDAM*ED any Political Policy. or "ISM".
Jessica-1170252 and others.
No Business should be in Business if their Products are contaminated for the sake of PROFITS. The ONLY reason for such conduct, is that they CHOOSE to have conditions affecting their products for a gain in PROFITS ONLY. Contamination of the Workplace can be solve for just a small cut in profits. It is not that expensive. It just means a through cleaning, then preventative cleaning on a regular basis. This is the requirement of the Owners, etc., not the general Public under any circumstance.
Its just like you or others cleaning the kitchen on a regular basis and wiping up any spills or splashes when they occur.
And they still claim to be just a "compounding pharmacy" and not a "drug manufacturer"?
Talk about loopholes....
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.
No it isn't. It's part of the "blame government" game to make government look like it doesn't work.
Mortman - you misunderstood my sarcastic comments - I believe you and me see eye to eye on this. I am a Safety and Enviromental professional and have worked int he manufacturing industry for many years - some of them in food production. I know that OSHA doesn't kill jobs, it saves lives - I also have seen OSHA loose the strength they had in the late 1980s to the shadow they are today, all because of the negativity perpetuated by big business. I have watched a half-dozen agents try to inspect food imports across all California ports, and similarly the FDA and USDA officials try to cover dozens and sometimes hundreds of manufacturing sites because there just aren't enough inspectors to go around, and unlike the 80s and 90s, inspectors today who levy violations are likely to get their asses kicked and loose their jobs as they are to see justice brought upon the violators. Self-Regualtion lol, I've worked for many companies over the past 30 years and only one of them would come close to being honest and worthy of self regualtion. All others - you would be putting your life (and more importantly your children's lives) in their hands - three words - DON'T DO IT! The ill informed citizens who continually repeat the "govenrment is too big" mantra evidently have no first hand experience in these matters.
Watch out compounding pharmacies. Your days of unfettered and unregulated practices are over, and not a minute too soon it sounds like.
The owners of these facilities need to be held criminally liable for the deaths that their drugs caused. That is the deterrent we need.
on the contrary, several weeks too late for the 438 sickened and totally too late for the 32 DEAD.
Gerry Spence outlined how a corporation should receive the death penalty, and under what circumstances. This company certainly merits it.
http://www.goodreads.com/book/show/799505.With_Justice_for_None
I'm curious to know why, exactly, compounding pharmacies that sold products injected into medical patients are somehow outside the FDA's jurisdiction...
Here's an interesting article about Romney's connection to this:
http://www.heraldonline.com/2012/10/31/4378575/the-oliver-law-group-alleges-new.html
gabriel
Because they don't manufacture these medications. They just mix what other company's manufacture. Also the courts say so. Stupid right? Next they will be saying corporations are people too.
It's not the courts that are stupid - it is the lawmakers who failed to set up the legal framework for proper regulation, inspection, and control. When they learn that a court has ruled against a necessary law, they need to correct the issue right away. Give the regulators resources (authority and budget.)
The courts seem to be in agreement with the taxing authority of government, so build the regulation around taxes (like health care reform.) Set up inspections that determine tax amounts - establish a million-dollar-tax for every deficiency. When taxes are not paid in a timely manner, use rapid confiscation, arrest, and imprisonment to enforce the rule of law. Courts go along with that stuff.
MAilman has it right, sort of. From boston.com
"For much of its history, the FDA has largely ignored compounding pharmacies, leaving their regulation mostly in the hands of state pharmacy boards, which have created a patchwork of rules and standards. But the low-profile business has long worried many in Washington.
The late Senator Edward M. Kennedy sought to bring clarity when he proposed the Safe Drug Compound Act of 2007. But the legislation never came to a vote because of opposition from compounding pharmacy lobbyists and other trade groups that argued such a law would prevent the speedy delivery of medications not available at traditional pharmacies."
If corporations are people, then the corporation that killed 38 people needs to be given the death sentence.
Clearly, it's a serial killer.
Ditto, Companies with contaminated food products.
Yes, if corporations are really "people", why can't they go to jail?
Sounds like "better than real people" to me.
Drown them in lawsuits. Criminally prosecute AND shoot that warning shot across the bow of all the other compounding pharmacies.
Lawsuits won't work, they will just declare bankruptcy after dragging things out for years...there simply isn't enough money. BUT all the people who were responsible for running this filth factory should prosecuted for murder! They knew they were not compliant with even the basic practices of sanitation. Definately a criminal matter.
They really do need to be held criminally liable. But we need to be careful how far down the food chain in the company we go in prosecuting. The foloks that should be held crimnally liable should be those people in a position of authority and able to do something about it and who didn't. What could happen is the Officers/owners of the companies could claim they did not realize the conditions and blame the lower level employees who could not do anything about the problems. But as a Quality professional I have to say if the quality and product safety folks in these companies were not heard by management they IMHO were obligated to blow the whistle. Might have cost them their jobs but it might have saved a few lives.
"Ameridose is committed to addressing all observations in order to enhance our existing systems"... we should be instead reading that "the FDA is committed to shutting down this plant permanently and fining those responsible (the owners) with multi-million dollar fines."
Now that this information is widely available, every ethical doctor, hospital, and pharmacy in the country should immediately return every product manufactured (not "compunded") by Ameridose and demand a full refund.
It should not matter a bit if Ameridose has a voluntary recall, or if any regulator issues an order for mandatory recall. The purchasers of the products can accomplish it. There will be a risk of financial loss on the products returned, but it is the right thing to do. Instantly stop paying any invoices and cancel any outstanding orders. The customers have the power to shut 'em down.
The FDA should shut down Ameridose for good & arrest every firm official involved! We all should refuse any medication made by compounding pharmacies until each and everyone of them has been thoroughly inspected.
Or by any Pharmaceutical Company or by any Company responsible for Food Contamination. Don't stop with these types of Companies.
Yeah, but how is a patient supposed to get info on where the drugs were compounded/manufactured? Some of the drugs this company made are for labor pain--how's a laboring woman supposed to ascertain where the oxy came from? These issues have to be dealt with because patients are often in no position to be able to get accurate info. I tried to find out where some of my injection serums were made and nobody could/would tell me. Do I stop necessary medical care? It's a very difficult position to be in--and patients should be able to trust that their medications were created under the proper conditions.
FDA finds contamination issues at a drug manufacturer! Sounds like we need to dump the FDA, without them we would have no problem.
Dude, the company just proved beyond a reasonable doubt, that they can't be trusted to regulate/monitor themselves, and you want to get rid of the agency that did find this mess? Do you reside in the state of Insanity? I guess it wouldn't matter then, if you got sick or died from medication that was produced there? Right? This is the perfect example of why businesses can't be trusted to regulate/monitor themselves.
He was being sarcastic.
Brent, he was being facetious.
Cool. Didn't know. Apoligies hubba. Hard to hear sarcasm from a keyboard.
Sarcasm is getting hard to detect as a big percentage of this country's population would actually make that kind of comment with a straight face.
Like someone said on another thread the fault for not getting the sarcasm lie not in the one making it, nor the one not getting it. It lie at the feet of all the morons who made obvious sarcasm not so obvious by having such moronic and illogical opinions.
REMEMBER that Congress has been drastically cutting funds for the FDA and other "Watch-Dog Agencies for DECADES. Cutting of funds also exists with State Agencies by State Legislatures. Simply put if you do not have money to operate, you cannot do your job properly.
PS: Want to ELIMINATE these "Watch-Dog" Agencies? If so, then may YOU suffer the consequences!!! Hear Ye, Right-Wing Conservatives!
This problem is just being found, after how long? What no inspections? Plus this was a result of a month long investigation and I pharmacy is still in operation and the FDA could only suggest that it recall all of it's products. Weren't there enough illnesses to trigger a mandatory recall or was it that no had been killed by this pharmacy, so far?
Problem is at the time the FDA had NO AUTHORITY over places like that. It wasn't until things blew up that they could do anything. That is because REPUBLICANS have been slowly reducing regulations on things like this while reducing funding to FDA inspectors. Republicans are all about DEFUNDING regulations so places like the FDA cannot enforce the laws. It's like having a police force of 1 person to enforce the laws of a city the size of New York. That is how Republicans do things and then they cry about how things didn't work and look to blame everyone but themselves. LOL
Simply! No PROPER FUNDING.
Riiiight. They should have been committed before the proverbial sh*t hit the fan. Shut them down. Criminally prosecute those that allowed those conditions to exist.
"the business of america is business" according to warren g harding.
all bow down to the glories of business! better yet unfettered business. they'll regulate themselves if they are going to compete in the magical marketplace. all hail the job creators! the answer to all our ills. ills? ills?
hmm, that sounds familiar.
Prison would be too good for the bastards.
If the FDA found violations as early as 2008 and did nothing about it, they should be held responsible as well.
No, not really. They can find things year after year and the companies can continue to refuse to comply, hiding behind their attorneys and 'response times' and so forth.
It does make you wonder, though, doesn't it?
boon
The state was responsible for inspections and enforcement at this place. Not the FDA.
Maybe it would be more effective for regulators to go right to the media with inspection results. Release the report publicly at the same time it is released to the company and their lawyers.
"Here are the problems we found. Here is a list of the products made at this location. Here are pictures of what the products look like. Here is a list of health care providers who have handled these products."
The deterrent would be a death sentence for the products. (Instead of the current system - scoring a bad inspection, and maybe getting around to corrections after a few months/years, following some appeals and lawsuits.)
That would work - except that in most states businesses have strong-armed the laws to their benefit, and all fines and enforcement actions against them are CONFIDENTIAL.
This is exactly why big business pushes for regulation at the state level. (Heck, they'd go for the local level if they could get away with it.)
Because their annual profits dwarf the entire budget of a lot of states and cities, allowing them to rule the roost by virtue of their "job creation".
It's a heck of a lot more expensive to strong-arm the feds, although you see that a friendly President in the White House (aka Bush) can be a great investment in that corner.
That's why they push for deregulation and getting rid of "job-killing regulations". (Now, where have we heard that before?...)
i hope everyone in that company goes to jail, lifetime for the owners and 5 yrs for employee's for failure to report this
And what was the CEO raking in and taking in because of NOT putting out money to have a plant that was up to FDA standards? I bet the owners and other higher ups have some big, big, Swiss bank accounts.
Don't worry; the CEO and other executives will be just fine - free of any liability in their LLC or Corporate protection of some sort!
They'll find someone to blame while they giggle about their money in the Caymans.
It's the American way these days, you see.
What are we paying the FDA inspectors for, seems they aren't doing their job.
We're NOT paying them. The FDA's budget was gutted by the Newt Gingrich congress long ago.
itsnot
The state was responsible for inspections and enforcement at this place. Not the FDA.
Really??? Is that all you got? I work for a multinational corp. and the amount of waste and fraud here is insane, yet they do nothing to change it. Guess that makes no difference if you are just on here trolling.
willie
And the private sector did a great job with that self-inspecting crap right?
My uinderstnading that Gov Romney (while Mass governor) took steps to protect this company:
Records from the FDA show that back in 2002 several people had adverse reactions to the medication in other shots produced by NECC involving Betamethasone repository another steroid.
Over six complaints were filed in 2006, but in 2004 the Mass. Board of Pharmacies that reported to Mitt Romney gave NECC clearance to continue with just a slight reprimand and NECC agreed to admit to negligence back then.
Read more: #ixzz2C7QhcDXk
Romney and Scott Brown both took caompaign dollars from the company.
Has any money changed hands that allowed these companies to go on for so long?
Those companies need to be closed down NOW! Someone is not doing their job.
Do you count campaign contributions to Mitt Romney?
These people need to go to jail. Surely, there is a crime here somewhere. I hope those that were sickened sue the pants off of these guys and the relatives of those that died do likewise. What a bunch of slimeballs.
I wonder if this company made the fentanyl that killed MJ?
Yes, we don't need regulations now, do we?
Big government, telling businesses how to operate cleanly and safely?
Businesses will self-regulate just fine, right?
What now, Republicans? What now, 'libertarians'?
Also, how much did the CEO make a year?
Okay conservatives!!! C'mon, explain to everyone how "the market will decide" and "there are too many regulations" and how "businesses will always do the right thing". C'mon. Tell us all how that works in conservative-land. I'm SURE that you guys don't mind filthy meds etc. when it's supplied by THE FREE MARKET SYSTEM. Right? C'mon... Tell us all how that works!!!
They're spinning it this way: See? Government is so big and stupid they couldn't see the obvious. Bad government! Gut their funding! More tax cuts! WOOO!
The pursuit of money can indeed make humans very evil it seems.
Ameridopes get a letter saying "You really should probably not make drugs anymore, the place is a little dirty and they hurt people. Really. You don't have to, though. Just askin'. Hope all is well. Love, the Federal Government."
I won't pay any taxes this year and see if I get the same sentiment in a letter from Washington. And I can not pay taxes without killing anyone!
quell
What does Washington have to do with this? The state was responsible for inspections and enforcement at this place.
Funny, just noticed I have two drug ads playing in the comments section.
Mucinex and Prevacid.
Irony!
Ah just another big company that for sure donates to the gop campaign that thinks they are above the law.Put the white collar workers in prison for manslater for fifteen years and the rest can make their choices as to where they are going to lock in in prison.This will cure more infection than you know.
Where were the whistleblowers? In this case yea shouldn't someone have discreetly blown a whistle?
o something else any pharmacist can make drugs from scratch not sure what regulations are on that.
yea I'm talking about joe pharmacist lives in the house in your neighborhood.
I'd trust most of them. No ones infallible though.
This place in the article though, pretty bad someone should have blown the whistle, and by not doing raises serious concerns of complicity whether indirectly or not.