Less government regulation in action

[Guns Guns Guns]

Six former employees described a corporate culture that encouraged shortcuts, even when that meant compromising safety. The former pharmacist said she was concerned about a pilot project in which quality control workers, rather than trained pharmacists, did preliminary checks to make sure the correct drugs were present and the pumps were set correctly before filling intravenous bags.


“I expressed my concern to the management,” said the pharmacist, who worked there in 2008 and 2009. “I said: ‘This isn’t right. These people don’t even know anything about the drugs.’ ”


She also said that because of pressure to increase output, there were a couple of “near misses.” One was when hydromorphone, a powerful narcotic, was made at twice the potency by a pharmacist who was working late to try to achieve production numbers for the day. The error was caught, however, before the bags left the plant.


“The emphasis was always on speed, not on doing the job right,” said the quality control technician who tried to stop the production line and who said he was eventually fired over disagreements about safety. “One of their favorite phrases was ‘This line is worth more than all your lives combined, so don’t stop it.’ ”





http://www.nytimes.com/2012/10/13/u...-firms-tied-to-meningitis.html?pagewanted=all

 

[Guns Guns Guns]

Which regulation do you think Obama didn't put in place that caused this?

Obama?

 

[Damocles]

Obama?

Regulations from the FDA are put in place through the Executive, so yes, which regulation did Obama not put in place that would have stopped this?

 

[Guns Guns Guns]

Regulations from the FDA are put in place through the Executive, so yes, which regulation did Obama not put in place that would have stopped this?

Curious.

Cite the enabling legislation.

 

[Damocles]

Curious.

Cite the enabling legislation.

The enabling legislation is the one that created the FDA putting it under the auspices of the Executive, allowing them to appoint and create regulations. Federal agencies, such as the FDA, are created by Congress and are part of the executive branch of government.

http://www.answers.com/topic/legislation-and-regulation

When the Congress created the FDA and put it under the power of the Executive they passed enabling legislation that gave the power of regulation to the executive.

Again, which regulation didn't Obama put in place that would have stopped this?

 

[Guns Guns Guns]

Maybe you missed these tidbits from your link:

A law establishing an agency is called "enabling legislation." Enabling legislation establishes the mission of an agency and defines its powers. It is the most important limitation on agency action. An agency has only the power it is given in its enabling legislation or by the state constitution. Agencies created by the legislature can have only the powers that the state and federal constitutions allow the legislature to delegate. The legislature can also modify the enabling legislation if it wants to change the agency's mission or powers.

Enabling legislation may be very specific as to the role of an agency and how the agency is to enforce the law, leaving the agency little discretion in its actions. More commonly, however, the legislature gives an agency a general mandate, such as "protect the public health," and directs the agency to decide the best way to do this. This allows the details to be developed by agency staff, and it makes it easier to respond to new threats and changing conditions because no new legislation is required. When the agency is charged with developing regulations, it must make them available to the public. This can be done through notice and comment rule making, which requires that proposed regulations be published for public comment, that the agency respond to the comments, and that the proposed regulation be revised and republished if necessary. The agency must also publish the information it relied upon to develop the proposed regulation, including whether it relied on private standards such as building codes or standards developed by other agencies. In some circumstances the agency may also have public hearings on proposed regulations. When the regulations are adopted, they are legally binding unless they exceed the agency's authority or conflict with other laws or the state or federal constitution. In emergencies, rules can be published and put into affect without a prior comment period, as long as they are subject to later revision. Thus the agriculture department might publish an emergency rule to block the import of BSE infected beef.

In addition to formal regulations, agencies publish documents that explain how the agency interprets the law, and how to comply with it. These guidance documents do not have the force of law, in that they are not binding on the courts. They are useful because they can provide a plain language explanation of formal regulations and enabling legislation, and thus assist the public with compliance. An agency can also provide guidance by publishing records of enforcement actions. While the agency is not bound to follow past precedent in all cases, it does provide useful information for regulated entities.

When the courts review a law passed by the legislature, they are obliged to uphold it unless there are constitutional problems with it. When courts review agency regulations, they determine whether the agency is constitutional, whether it is within the powers delegated to the agency, whether the delegation is constitutional, and whether the agency followed the correct procedures for promulgating or enforcing the regulation. If the regulation passes this test, the court will defer to the agency's expertise on nonlegal matters. In a classic public health case, Jacobson v. Massachusetts (1905), the United States Supreme Court found that a regulation requiring smallpox vaccination could not be over-turned just because some scientists disagreed with it. The Court established the standard that it is the agency's role to choose from available regulatory alternatives, and in the process to balance the needs of the individual and those of the state. The courts will not second-guess such decisions unless they are outside the agency's legal authority, or if the agency acted in an arbitrary and capricious manner in promulgating or enforcing the regulation. Without this deference, public health regulation could often be stalled in the courts. In a modern example, the courts have allowed health departments to require the named reporting of HIV (human immunodeficiency virus) infection, despite opposition by some public health officials.

http://www.answers.com/topic/legislation-and-regulation#ixzz29CBXJIS6
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[Guns Guns Guns]

Now, back to the subject of the thread:

Congress Jumps on Meningitis Outbreak

http://www.medpagetoday.com/Washington-Watch/Washington-Watch/35297

 

[Damocles]

Can you tell me which regulation Obama failed to establish that would have saved these people? And can you tell me why he hasn't put them in place after the fact?

 

[Guns Guns Guns]

Can you tell me which regulation Obama failed to establish that would have saved these people? And can you tell me why he hasn't put them in place after the fact?

Speaking of failure...can you explain how the President of the United States "puts" or "establishes" "regulations in place", since your prior attempt bombed?

 

[Damocles]

Speaking of failure...can you explain how the President of the United States "puts" or "establishes" "regulations in place", since your prior attempt bombed?

Your definition of bomb is clearly different than most people's. The reality is, the executive branch is responsible for establishing the regulations for the FDA. Can you tell me what regulation which Obama should have enacted to save these people and why it hasn't been established now that we realize it was so clearly missing?

 

[Guns Guns Guns]

The reality is, the executive branch is responsible for establishing the regulations for the FDA.

The reality is that you haven't shown that to be the case.

 

[Damocles]

The reality is that you haven't shown that to be the case.

The reality is, you are simply incorrect. Again, please inform me what regulation would have saved these people and tell me why Obama hasn't enacted it through the FDA, a regulatory entity under the Executive branch of government?

 

[Guns Guns Guns]

The reality is, you are simply incorrect.

The reality is that you can't back up your assertion that presidents put FDA regulations in place.

Can you, or not?

 

[Guns Guns Guns]

What regulation do you propose that would have prevented this? Specifics please

Damo's fellow traveler wants to know the same thing, apparently.

Is the president the one who puts FDA regulations in place?

 

[Damocles]

The reality is that you can't back up your assertion that presidents put FDA regulations in place.

Can you, or not?

Twice I have explained to you why the HHS (which is over the FDA) is under the control of the executive, shoot it is a cabinet post, are you incapable of acting as if you can understand what you read?

And again, what regulation do you believe that Obama should have enacted in order to save these people, and why didn't he? Was it because he's a closet republican, or did he just want these people to die? Was the company actually following current regulations, or did they violate them?

Why do you seem so ignorant? And lastly... Why are you afraid of answering my questions?

 

[Cancel 2018. 3]

http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm

 

[Guns Guns Guns]

Twice I have explained to you why the HHS (which is over the FDA) is under the control of the executive, shoot it is a cabinet post, are you incapable of acting as if you can understand what you read?

You have pretended that the president dictates regulatory policy. Does that make it true?

Nobody claimed FDA wasn't an Executive agency under HHS, did they?

Unfortunately for you, your claim was that "Obama" has the responsibility to "put in place"FDA regulations and "failed to establish" them.

You have "failed to establish" any substantiation, haven't you?

Got any?

Can you tell me which regulation Obama failed to establish that would have saved these people? And can you tell me why he hasn't put them in place after the fact?

Nope. Can anyone?

Can you show how "Obama" failed to "put it place" FDA regulation or is your litany an attempt to disguise the fact that conservatives favor deregulation?

And again, what regulation do you believe that Obama should have enacted in order to save these people, and why didn't he? Was it because he's a closet republican, or did he just want these people to die?

LOL.

Was the company actually following current regulations, or did they violate them?

Why do you seem so ignorant?

As a cursory examination of the known facts presented in this thread, the answer is "no".

Why do you seem so ignorant?

How do I "seem so ignorant"?

And lastly... Why are you afraid of answering my questions?

Where'd you get the idea that I'm "afraid"?

 

[Guns Guns Guns]

One more person has died from fungal meningitis linked to tainted steroid injections, raising the death toll for the outbreak to 15.



The U.S. Centers for Disease Control and Prevention today reported that 198 people in 13 states have contracted fungal meningitis after receiving spinal injections of methylprednisolone acetate for back pain.



http://abcnews.go.com/Health/cdc-reports-15th-meningitis-death/story?id=17472084#.UHoCTNkiTqI

 

[Damocles]

You have pretended that the president dictates regulatory policy. Does that make it true?

I have? Reality: The President can present regulation to the HHS leader in his cabinet and has huge influence in whether it gets enacted, don't you think?

Nobody claimed FDA wasn't an Executive agency under HHS, did they?

Yet somebody here, named Charlie Brown Shirt, did pretend that it wasn't something the President could have affected in any way, didn't he?

Unfortunately for you, your claim was that "Obama" has the responsibility to "put in place"FDA regulations and "failed to establish" them.

Incorrect, I asked you what regulation he could have put in place that would have solved it and why he didn't even suggest it. Is this another instance of reading comprehension deficit disorder?

You have "failed to establish" any substantiation, haven't you?

Got any?

No. I have fully explained that the executive can affect regulation and why, but you have failed to answer what regulation you think he could have enacted that would have saved these people, didn't you?

Nope. Can anyone?

Well, since we know that the executive branch is in charge of regulatory agencies, and you suggested that the Congress should have done something, we can determine that you would have some ideas as to what regulations you think would have saved these people, considering it was deficit of regulation you have blamed for the incidents. The only agencies that can put those regulations into effect are under the auspices of the President, this is his responsibility. At least you admit when you don't have any ideas, so now we can move on to: Can you name what regulations the Administration has removed that you are now saying caused this, should you suggest they immediately put them back in place?

Can you show how "Obama" failed to "put it place" FDA regulation or is your litany an attempt to disguise the fact that conservatives favor deregulation?

Can you actually act on the reality that new regulations would be set into effect by the Executive branch and that since it is controlled, and has been for the past three and a half years, by a Democrat and that this, therefore, is just nonsense and blather?

LOL.

What regulation do you think Obama should left in place in order to save these people? I know you think dying people is funny, but it is something you should be able to answer since it is the dearth of regulation that you think caused it, right?

Why do you seem so ignorant?

Really? The only answer you have for a question is to repeat it? Okay, now that you've repeated it can you answer it?

As a cursory examination of the known facts presented in this thread, the answer is "no".

If the company wasn't following current regulations, how would more regulation have fixed this and why do you believe that this was a problem with too little regulation?

How do I "seem so ignorant"?

How do you not? You come in here and put up a thread saying that this was caused by "less regulation" but have no understanding of which branch of government enacts regulation as opposed to legislation, then when asked what further regulations would have resolved it have no ideas and less comprehension of how a President can affect regulations in the various agencies under his purview, how could we possibly come to any other conclusion than ignorance on your part?

Where'd you get the idea that I'm "afraid"?

Why do you never answer questions? Do you understand that such consistent avoidance creates an appearance of fear?

 

[Guns Guns Guns]

I have? Reality: The President can present regulation to the HHS leader in his cabinet and has huge influence in whether it gets enacted, don't you think?

Can you cite some past examples of this process in action?

BTW, Ted Kennedy wanted to impose more regulation on compounding pharmacies a few years back.

Guess what happened?

Yet somebody here, named Charlie Brown Shirt, did pretend that it wasn't something the President could have affected in any way, didn't he?

If that's true, you should be able to link up. Do it.

Incorrect, I asked you what regulation he could have put in place that would have solved it and why he didn't even suggest it. Is this another instance of reading comprehension deficit disorder?

So now you claim that you asked why Obama "didn't even suggest it"? Link up.

No. I have fully explained that the executive can affect regulation and why, but you have failed to answer what regulation you think he could have enacted that would have saved these people, didn't you?

You have expressed your opinion that the executive is responsible for regulation, unsupported by evidence.

I never said Obama could enact any regulation at all in this case, have I?

Well, since we know that the executive branch is in charge of regulatory agencies, and you suggested that the Congress should have done something, we can determine that you would have some ideas as to what regulations you think would have saved these people, considering it was deficit of regulation you have blamed for the incidents. The only agencies that can put those regulations into effect are under the auspices of the President, this is his responsibility. At least you admit when you don't have any ideas, so now we can move on to: Can you name what regulations the Administration has removed that you are now saying caused this, should you suggest they immediately put them back in place?

Can you actually act on the reality that new regulations would be set into effect by the Executive branch and that since it is controlled, and has been for the past three and a half years, by a Democrat that this is just nonsense and blather?

So you're still contending that a president controls regulation of industries by federal agencies?

What regulation do you think Obama should have put in place in order to save these people? I know you think dying people is funny, but it is something you should be able to answer since it is the dearth of regulation that you think caused it, right?

How do you "know" that I think "dying people is funny"?

While you're looking for a way to prove that statement, cite my post that says I think a "dearth of regulation" "caused it".

Really? The only answer you have for a question is to repeat it? Okay, now that you've repeated it can you answer it?

I was directing the question to you. Can you answer it, or not?

If the company wasn't following current regulations, how would more regulation have fixed this and why do you believe that this was a problem with too little regulation?

Who said "more regulation" would have "fixed this"?

It's ironic that you don't seem certain there is too little regulation, but want to blame Obama for the deaths of innocent Americans.

How do you not? You come in here and put up a thread saying that this was caused by "less regulation" but have no understanding of which branch of government enacts regulation as opposed to legislation, then when asked what further regulations would have resolved it have no ideas and less comprehension of how a President can affect regulations in the various agencies under his purview, how could we possibly come to any other conclusion than ignorance on your part?

You seem to be all worked up. Have you been neglecting your hives too long?

Who's the ignorant one...someone who claims the president can "put in place" regulations, or someone who didn't make that statement?

Why do you never answer questions? Do you understand that such consistent avoidance creates an appearance of fear?

Am I responsible for your misperceptions?

I guess the House Republicans don't know that Obama is supposed to "put in place" FDA regulations.

Maybe you should straighten them out, because they seem to think Congress has a role to play.




The Republican-led House Energy and Commerce Committee said it would hold a briefing with the FDA and CDC as lawmakers requested information from the agencies on what it knew about the New England Compounding Center (NECC), the source of the meningitis outbreak.



Republican Sens. Bob Corker and Lamar Alexander, both from Tennessee -- the state hit hardest by the outbreak -- sent a letter to FDA Commissioner Margaret Hamburg, MD, Friday seeking inspection information about NECC and actions taken against it as well as clarity on existing laws on oversight of compounding pharmacies.





http://www.medpagetoday.com/Washington-Watch/Washington-Watch/35297