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Subscribe to RSSBOSTON -- Criminal investigators from the Food and Drug Administration were reportedly at the offices of the Massachusetts compounding pharmacy at the center of a nationwide fungal meningitis outbreak Tuesday, even as U.S. legislators demanded that the Department of Justice investigate whether the New England Compounding Center violated federal laws or regulations.
FDA agents were seen going in and out of the brick office building on Waverly Road in Framingham, Mass., according to reports from the Boston Globe newspaper. They were wearing jackets bearing the initials "FDA OCI," which stand for the FDA's Office of Criminal Investigations.
Meanwhile, Rep. Edward Markey, a Massachusetts Democrat, told the department in a letter that New England Compounding Center may have tried to skirt federal policy on the sale and distribution of controlled substances.
U.S. Sen. Richard Blumenthal, a Connecticut Democrat, also has asked the Justice Department to launch a criminal probe into the outbreak, which is linked to steroid shots distributed by NECC.
A spokesman for NECC had no comment on Markey's letter but says the company is cooperating in ongoing probes by other agencies.
The Centers for Disease Control and Prevention says 233 illnesses, including 15 deaths, in 15 states are linked to the outbreak.
© 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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These compounding pharmacies are only supposed to make up compounds in response to specific prescription or an order from health care provider. They are not licensed to do wholesale manufacturing of drugs, which is what this pharmacy was doing. I do not understand why this was allowed to go on for so long. The FDA definitely fell down on the job of keeping of watch over this pharmacy. It is also suspected that there are several other compounding pharmacies illegally operating in this manner. These pharmacies are operating as drug manufacturers and not pharmacies and need to be shut down. It appears that the FDA was well aware that this had been going on and did done nothing to stop it. There are many compounding pharmacies out there that operate in a legitimate manner in accordance with their license, filling a very important need, and they should not end up getting painted with the same brush as the handful of pharmacies that are operating illegally. I rely on one such pharmacy to make up medication for me from two different drugs that are not typically available in a form that a person can take at home. They operate within the law and only make up drugs in response to a specific prescription or order from a health care provider, they do not manufacture for wholesale. It would be a shame if some knee jerk reaction by the FDA hurt the ability of legitimate compounding pharmacies to do business.
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.
Fear not! No one will go to jail. The company will just get a big fine.
One of the network news shows said they are going to investigate to see if this company also caused other disease outbreaks.
I trust this is how the GOP knows where the problems in our Government are, they created them!
A previous article stated that they were supposed to be compounding drugs on a per patient basis. Mass production was clearly outside the scope of their license. Zombie Capitalists, killing for money, nothing new there. That is why we must have the dreaded government oversight. If the feds had the power, they may have shuttered this outfit before anybody died. The FDA had issued warnings about cleanliness and mass production to them before. Somebody should hang for this.
Bastards should be charged with murder! Its all about the money.
As its been said above, yes, we need government oversight. The private economy cannot regulate itself. Money will always rule. Thats why there are multi-million dollar settlements over scalding coffee. Without oversight, these companies will just take their chances. Even if it means some people have to die.
If this was China, those bastards would have already been found guilty and shot. Vote for Romney and you'll see less regulation and more capitalist running amuck.
To quote a certain candidate........concerning Medicare............... "The private sector can do it better"
Yeah,....sure.
The Commonwealth of Massachusetts is also to blame.
This is the second major scandal to hit the Mass. Dept. of Public Health. First, as a result of mismanagement and lack of oversight, THOUSANDS of drug cases are now compromised and many criminals may go free (while some innocent individuals may have been sent to prison).
Second, as a result of lack of oversight, hundreds or thousands of people may have been exposed to defective medicine and many have died. Where were our inspectors looking into these companies?
If our governor, Deval Patrick, would show some leadership skills and get engaged in actually running the state, instead of spending his time seeking a cabinet post in Washington, maybe we wouldn't have drug lab scandals and drug company scandals.
I've lived in Massachusetts all my life. It is a wonderful state with wonderful people and places to visit. But it is one of the most corrupt places in America. We've had 3 House Speakers resign due to indictments, allegations, convictions....we have a $15 billion Big Dig that's full of problems - leaks, falling ceilings (1 dead), rusting lights...we have the highest per capita debt load of any state. It's just dysfunctional. I wish there were someone, somewhere...some agency or court or something that could just come in and take control over this mess. I'm an Independent, but I can see the results of many years of one-party rule. These people need to go. My sympathies go out to the families of the people who have died from these medicines.
Yep, the GOP wants less regulation is a fact. There are ways to circumvent the law. I haven't got all the facts, but it sounds like the lawyers will be lawyering up with lawsuits. But it won't bring anyone back. Lawyers are bottom seeking scum=cockroaches. Go chase some ambulances...
These guys need to learn stupid and greedy hurts.
It is a crime, along with all the other human experimentation still ongoing today, with all the pharmaceutical and agrochemical fake foods and abuses of animals and humans. Error doubt that. Planned? Maybe. Careless, amoral, unethical and uninformed consents and unwitting patients, took a judge to die from this for investigations to prove criminal intent? How much is a human life worth anymore? The Americans did this, again and again. They just never stop. Well, we'll see how much those "scientists" lifes are worth and all their "education" and grants and institutional funds when all the money STOPS and people stop dying from all this junk science and destroying the planet as fast as they can. All the world needs to get off the greed.
Go on Youtube and watch the Bilderberg Group conspiracy theory with Jesse Ventura. It's all about depopulation the world in 2012.
Were the patients informed that their medication was not FDA approved? Someone dropped the ball. Sounds like murder to me.
Oh well, these things happen sometimes. The most important thing is that we get rid of all the "job killing" regulations and allow the poor, over-taxed corporations to self-regulate.
FDA, another failed attempt by a Government agency. Why do we have an FDA with their constant FU**ups. Excuse will be, we are undermaned. yes there should be an investigation and the FDA should be the one investigated
The FDA are undermaned? I never realized that the inspectors were horses. No wonder they botched this!