Less government regulation in action

[Damocles]

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?

How about a story where the people who work there are pissed at the current President for too heavily politicizing regulation, sounds like they do have influence and really can enact regulation that even the FDA doesn't want, doesn't it? You'll note in the story how Sibelius, the current holder of the cabinet position for HHS, has massive control over the regulations, even to a level as to what pills will be available to whom...

http://www.fiercepharma.com/story/fda-battling-white-house-over-politicization-regulation/2012-04-03

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

You want me to link back to this thread? Okay.

http://www.justplainpolitics.com/showthread.php?45177-Less-government-regulation-in-action

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

Again you want me to link to this thread?

http://www.justplainpolitics.com/showthread.php?45177-Less-government-regulation-in-action

Pay particular attention to posts where I asked you what regulations Obama should have put in place and why he hadn't?

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

Incorrect several times we have shown you that the executive is responsible for regulatory agencies.

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

You did, however, say that a dearth of regulation was the cause and since regulatory agencies are under the auspices of the executive it can only be ignorance that would say that you didn't think he could.

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

Correct. The President's office controls the regulatory agencies and has huge power over the regulations, it is one of the reasons that those running for President often promise to enact or remove regulations.

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

Because you laughed at it here in this thread.

http://www.justplainpolitics.com/showthread.php?45177-Less-government-regulation-in-action

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

The title of this thread says that "less regulation" caused this.

http://www.justplainpolitics.com/showthread.php?45177-Less-government-regulation-in-action

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

You were repeating the question because you didn't want to answer it, will you?

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

The person who entitled the thread as "less regulation" caused it.

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.

What is ironic is that you start a thread saying that "less regulation" caused a problem then later try to suggest you didn't think more regulation would fix it. Why say that "less regulation" caused it if you don't think that more would have stopped it?

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?

The one who doesn't know which branch of government is responsible for regulatory agencies is the one that seems ignorant.

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.

Maybe you should understand that Congress didn't remove any regulations, and couldn't, before you post a thread saying that "less regulation" caused the problem that you want to blame on the party that doesn't hold the WH.

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

Maybe you should recognize that asking for information is not enacting regulation, and that this branch has oversight but not regulatory powers once they create an agency... It was explained in that link earlier where I showed that the legislative branch creates the agency, and has approval powers of the appointees, but regulation is created through the agency which is under the auspices of the executive branch...

You bolded a portion of it, one about the courts ruling on whether regulations are constitutional or not and how they rule differently if it is a regulation as opposed to legislation, but it didn't really apply here. It is one of the things that made me question why you were pretending an incapacity to comprehend things...

 

[Guns Guns Guns]

How about a story where the people who work there are pissed at the current President for too heavily politicizing regulation, sounds like they do have influence and really can enact regulation that even the FDA doesn't want, doesn't it? You'll note in the story how Sibelius, the current holder of the cabinet position for HHS, has massive control over the regulations, even to a level as to what pills will be available to whom...

And?

You want me to link back to this thread?

Nope. I want you to cite a quote of mine that proves I said what you claimed I did.

Again you want me to link to this thread?

Nope. Again, I want you to cite a quote of mine that proves I said what you claimed I did.

Pay particular attention to posts where I asked you what regulations Obama should have put in place and why he hadn't?

Still claiming that "Obama should have" regulated compounding pharmacies, I see.

Incorrect several times we have shown you that the executive is responsible for regulatory agencies.

No, you haven't.

You stated correctly that HHS is a Cabinet-level post whose director is nominated by the president.

You haven't proven that the president puts federal regulations in place, which is what you claimed.

You did, however, say that a dearth of regulation was the cause and since regulatory agencies are under the auspices of the executive it can only be ignorance that would say that you didn't think he could.

Quite a stretch. In another thread you made excuses for a past president who didn't implement regulations. I understand that you think Obama can, but he can't.

Correct. The President's office controls the regulatory agencies and has huge power over the regulations, it is one of the reasons that those running for President often promise to enact or remove regulations.

Backpedal much? Either Obama has "huge power" or he "puts in place" regulations...or are you saying he can do both?

Because you laughed at it here in this thread.

Incorrect. I laughed at your questions. These questions:

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?

They're laughable.

The title of this thread says that "less regulation" caused this.

No it doesn't. It says "Less government regulation in action".

You were repeating the question because you didn't want to answer it, will you?

I was?

The person who entitled the thread as "less regulation" caused it.

Would that be the mysterious made-up "Charlie Brown Shirt"?

What is ironic is that you start a thread saying that "less regulation" caused a problem then later try to suggest you didn't think more regulation would fix it. Why say that "less regulation" caused it if you don't think that more would have stopped it?

Where's this thread that says "less regulation caused a problem"?

It's sure not this one.

This one says "Less government regulation in action".

The one who doesn't know which branch of government is responsible for regulatory agencies is the one that seems ignorant.

Who's that?

It ain't me.

On the other hand, how ignorant is a person that clings stubbornly to the belief that because an agency falls under a Cabinet-level Secretary, the president makes the regulations that get applied to industries like compounding pharmacies?

Maybe you should understand that Congress didn't remove any regulations, and couldn't, before you post a thread saying that "less regulation" caused the problem that you want to blame on the party that doesn't hold the WH.

Who said Congress removed any regulations?

Who said "less regulation" caused the problem?

Who blamed "the party that doesn't hold the WH"?

Maybe you should recognize that asking for information is not enacting regulation, and that this branch has oversight but not regulatory powers once they create an agency...

Backpedaling again?

It was explained in that link earlier where I showed that the legislative branch creates the agency, and has approval powers of the appointees, but regulation is created through the agency which is under the auspices of the executive branch...

First, it was Obama that was responsible for regulations, now it's "the agency under the auspices of the executive branch"? Which is it?

You showed that the executive branch creates agencies like the FDA without enabling legislation? Is that what you think?

Maybe you should read up on the Pure Food and Drug Act.

You bolded a portion of it, one about the courts ruling on whether regulations are constitutional or not and how they rule differently if it is a regulation as opposed to legislation, but it didn't really apply here. It is one of the things that made me question why you were pretending an incapacity to comprehend things...

Nonsense.

According to you, all Obama has to do is "put in place" a regulation, right?

 

[Guns Guns Guns]

The current fungal meningitis outbreak has put a spotlight on compounding pharmacies, and regulators and stakeholders say Congress needs to clarify exactly who should regulate these entities.


The practice of compounding, which has been around for decades, was intended to give pharmacies the ability to produce a product under a doctor’s orders when a particular drug wasn’t available. It can also allow pharmacists to concoct alternative delivery methods, add flavors, or sidestep any inactive ingredients a patient may be allergic to.



The original intent was for the pharmacy to produce one drug for one patient at the request of one physician.



But compounding pharmacies have slowly grown over recent years — even industry trade groups are unsure exactly when that began — and in some cases have started to act like small manufacturers. Companies like the New England Compounding Center (NECC) in Framingham, Mass., ship thousands of vials of product all across the country.



Now industry attorneys, government regulators, and other stakeholders say Congress needs to act to clarify who has authority to regulate such practices. The FDA — despite clamoring for such power before — has had most, if not all, of that authority taken away and it now lies with states, where regulations and oversight vary widely.



In a nutshell, pharmacies, including compounders, are regulated by states; drug manufacturers are overseen by the FDA.



The possible problems that can ensue because of the fuzzy line that separates one group from the other came into sharp focus in the past week when fungus-tainted batches of the steroid methylprednisolone acetate made by NECC sparked the meningitis outbreak that sickened and killed people in 12 states.


“It’s a gray area because there’s no clear standard as to when the pharmacy crosses the line and looks more like a manufacturer than a compounding pharmacy,” said Linda Bentley, a Boston attorney with Mintz Levin who advises manufacturers on FDA regulatory law. “I mean, that’s a big hole. The problem is that it’s hard to know where the edges are.”



The FDA’s role in overseeing compounding pharmacies has been muddled by legislation and court cases over the years, so now it’s difficult for even the agency to understand what — if any — authority it has, Joe Cabaleiro, executive director of the standards group the Pharmacy Compounding Accreditation Board, told MedPage Today.



The landmark 1938 Food, Drug, and Cosmetic Act, which outlines the FDA’s authority, doesn’t mention compounding.



In 1997′s FDA Modernization Act Congress specifically mentioned compounding, but it exempted compounded drugs from some of the oversight required for licensing of new drugs provided certain conditions were met.



Charles Raubicheck, partner at Frommer Lawrence & Haug in New York City and head of the firm’s FDA law group, explained to MedPage Today that the 1997 changes provided a safe harbor for compounding oversight — as long as a drug’s production quantity was limited, it was based on a valid prescription, and was produced with FDA-approved materials.



The part of the law that gave the FDA authority to regulate marketing practices of compounding pharmacies was declared unconstitutional by the Supreme Court in 2002, after one such pharmacy challenged it.



Different circuit courts ruled the entire compounding section of the law unconstitutional, but the Supreme Court kept all but the promotional portion intact. Legal experts point to the case as an example of the complexities courts have introduced, making it difficult for the FDA to apply the law.



In 2009, the FDA was rebuffed by a Colorado district court when the agency tried to exert its authority over a compounder it believed was acting like a manufacturer.



http://www.kevinmd.com/blog/2012/10/compounding-pharmacies-stricter-fda-oversight.html

 

[Damocles]

First, it was Obama that was responsible for regulations, now it's "the agency under the auspices of the executive branch"? Which is it?

You showed that the executive branch creates agencies like the FDA without enabling legislation? Is that what you think?

Maybe you should read up on the Pure Food and Drug Act.

I never showed that it creates the agency, I showed that legislation creates the agency which creates the regulation. Do I have to actually start in on the "I'll go slow" and other stuff or can we actually hold a conversation where you stop pretending not to comprehend what you read?

Seriously, I get tired of stupid games like that. I believe you are smarter than that.

I notice you once again ignored a link that showed the regulations being enacted by the HHS so you could claim that there is no possible way that the executive could effect or have responsibility for regulations.

The executive is responsible for regulation, I remember... I think it was even on this board, Desh complaining about how Bush changed the regulations for the FDA. They can and do change regulations, if you believe it is "less regulation" that caused this the only source of that would be the Administration, you need to come up with regulations that they removed that you think caused this if you are going to continue to claim "less regulation" as the cause.

Nonsense.

According to you, all Obama has to do is "put in place" a regulation, right?

Now you are just being foolish. We posted a link as to how the regulation would come into effect, now can you tell me which regulation Obama removed that caused "less regulation" and thus this problem happened? Can you show which regulation that the Congress removed by some magical means that isn't at their disposal? What regulation was removed to cause "less regulation" that caused this problem? You were the one that created the thread claiming that this was "less regulation in action" it is up to you to back up the claim.

Since it is now clear that you are entirely ignorant, and remain so regardless of being informed of your lack (thus indicating it is the state which you prefer), of how regulations come into effect and how the Executive can, has, and does affect regulation directly and indirectly. If you still believe that this is an example of "less regulation in action" you must be able to show which regulation this Administration allowed to be removed that caused this...

If you cannot, then you should chalk the thread up to a learning experience and move on.

You made the claim, back it up, Homeslice. One regulation that caused this... Just one, that's all you need. Then you can tell me why you believe that the Obama Administration has not worked to establish that regulation, how you have suggested they should, when you sent the letter... Just some example that you actually understand that the Executive branch is responsible for regulatory agencies would do, though it wouldn't show you are right in your suggestion that this is an example of "less regulation in action" it would serve to show that you learned something and make my time somewhat worthwhile.

 

[Guns Guns Guns]

I never showed that it creates the agency, I showed that legislation creates the agency which creates the regulation. Do I have to actually start in on the "I'll go slow" and other stuff or can we actually hold a conversation where you stop pretending not to comprehend what you read?

Seriously, what does this even mean?

The FDA was created by legislation.

The FDA creates regulations under specific legislation passed by Congress and subject to interpretation by the courts.

http://en.wikipedia.org/wiki/Food_and_Drug_Administration_(United_States)

http://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act

http://en.wikipedia.org/wiki/Food_Safety_and_Modernization_Act

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm090410.htm

Obama does not "put in" regulations, which is what you keep alleging.

Seriously, I get tired of stupid games like that.

Then why do you play them?

I believe you are smarter than that.

Sure you do.

I notice you once again ignored a link that showed the regulations being enacted by the HHS so you could claim that there is no possible way that the executive could effect or have responsibility for regulations.

"Effect"? LOL.

You said asked repeatedly what regulations Obama should have "put in".

Not HHS. Obama.

Not FDA. Obama.

Not Congress. Obama.

Obama signs the bills Congress passes (or he vetoes them), which puts the laws into effect, subject to legal challenges before the Judiciary.

http://en.wikipedia.org/wiki/Separation_of_powers

The executive is responsible for regulation, I remember... I think it was even on this board, Desh complaining about how Bush changed the regulations for the FDA. They can and do change regulations, if you believe it is "less regulation" that caused this the only source of that would be the Administration, you need to come up with regulations that they removed that you think caused this if you are going to continue to claim "less regulation" as the cause.

Back to claiming that I said "less regulation" was the "cause" of something?

The fact that you are citing Desh (of all people) from memory and not providing a link is telling.

We posted a link as to how the regulation would come into effect, now can you tell me which regulation Obama removed that caused "less regulation" and thus this problem happened?

Who's "we"? Are you including your imaginary friend "Charlie Brown Shirt"? I didn't claim that Obama removed any regulations, did I?

Can you show which regulation that the Congress removed by some magical means? What regulation was removed to cause "less regulation" that caused this problem?

Nobody claimed that any regulation was removed, did they?

You were the one that created the thread claiming that this was "less regulation in action"...

And it is.

Since it is now clear that you are entirely ignorant, and remain so regardless of being informed of your lack (thus indicating it is the state which you prefer), of how regulations come into effect and how the Executive can, has, and does affect regulation directly and indirectly.

Spurious.

If you still believe that this is an example of "less regulation in action" you must be able to show which regulation this Administration allowed to be removed that caused this...

Fallacious thinking. An absence of regulation does not mean ergo that a prior regulation was removed.

If you cannot, then you should chalk the thread up to a learning experience and move on.

You want me to argue a position I don't hold?

Clearly, you are having a hard time moving on, aren't you?

You made the claim, back it up, Homeslice.

What claim was that?

I've posted facts, and links to relevant articles.

If you can rebut anything I've said, do so.

 

[Guns Guns Guns]

Illinois may have its first case of fungal meningitis linked to possibly tainted vials of a steroid medication that is blamed for 15 deaths across the country, state and federal health officials said Saturday.


The person is a Chicago resident who has "signs of meningitis," said Melaney Arnold, a spokeswoman for the Illinois Department of Public Health, calling the case "probable."


The person received an injection of the possibly tainted medication at a Chicago-area health care facility, Arnold said. The person is being treated in a hospital, but Arnold said she could not provide additional information about the person's condition, age or gender and could not identify the facility that administered the injection.



The person is undergoing tests to confirm whether his or her case is definitely linked to the outbreak, Arnold said.


The total number of people across the country stricken with meningitis in the outbreak reached 201 Saturday...





http://www.chicagotribune.com/news/local/ct-met-meningitis-20121014,0,7310152.story

 

[Damocles]

What claim was that?

I've posted facts, and links to relevant articles.

If you can rebut anything I've said, do so.

What you posted was a claim that this was caused by "less regulation in action" and have posted nothing to back that up. When presented with actual information as to who is responsible for regulation you have tried to act as if you cannot comprehend the information. I posted links that backed it up, one even with the FDA complaining about Sibelius being too political in the regulation she enacted. You have tried to pretend that you can't comprehend it.

Your first post claimed that this was "less regulation in action"... We'll start all over.

Tell me, which regulations were changed that you think caused this and do you fully understand that the FDA is under the executive who is not republican and therefore if this is caused by "less regulation" why do you think this Administration hasn't acted to enact the regulation you think would have saved these people?

 

[Rune]

Wow, talk about obtuse.

 

[Guns Guns Guns]

What you posted was a claim that this was caused by "less regulation in action" and have posted nothing to back that up.

Incorrect.

I never claimed any causal effect.

When presented with actual information as to who is responsible for regulation you have tried to act as if you cannot comprehend the information. I posted links that backed it up, one even with the FDA complaining about Sibelius being too political in the regulation she enacted. You have tried to pretend that you can't comprehend it.

LOL, "actual information"...so you think there's another kind?

Very telling.

Sibelius and the FDA don't regulate compounding pharmacies, so your article has no relevance to the subject, does it?

Your first post claimed that this was "less regulation in action"... We'll start all over.

This is "less regulation in action".

The FDA does not regulate compounding pharmacies.

I thought conservatives would rejoice that there's an industry that isn't regulated by a federal agency.

Tell me, which regulations were changed that you think caused this and do you fully understand that the FDA is under the executive who is not republican and therefore if this is caused by "less regulation" why do you think this Administration hasn't acted to enact the regulation you think would have saved these people?

Since I never said any regulations were changed, or that changing a regulation caused anything, your question is moot.

 

[Guns Guns Guns]

[h=1]Mass. pharmacy industry resists call for stricter regulation[/h]


The Framingham company, NECC, misled state officials and was operating outside of the bounds of its pharmacy license.


The state director of the Bureau of Health Care Safety and Quality, Madeleine Biondolillo, says there’s no evidence other compounding pharmacies around the state are violating their licenses.


Still, she says officials want them to swear to it.


“The Board of Pharmacy has issued an order requiring that all compounding pharmacies in the commonwealth sign an affidavit attesting compliance with all pertinent laws and regulations,” Biondolillo said.


http://www.wbur.org/2012/10/11/compounding-pharmacies-mass

 

[Damocles]

Incorrect.

I never claimed any causal effect.

I see, so when you claim it is "less regulation in action" you are now claiming that it wasn't "less regulation" that caused it?

LOL, "actual information"...so you think there's another kind?

Very telling.

Inane, it is simply a way to stress the meaning in conversational English. A sad attempt to distract from the discussion.

Sibelius and the FDA don't regulate compounding pharmacies, so your article has no relevance to the subject, does it?

So you now understand that she does enact regulation and that the lack thereof could indeed have been filled through efforts of the Administration?

This is "less regulation in action".

In what way? If it is "less" then it is clear you believe that "more" would fix it, what regulation do you believe would have stopped this from happening?

The FDA does not regulate compounding pharmacies.

That is up for debate, according to your originating article. If you believe that more regulation of this industry is the answer, then why are you not asking Obama to work towards regulating compounding pharmacies rather than blaming people who cannot?

I thought conservatives would rejoice that there's an industry that isn't regulated by a federal agency.

Since I never said any regulations were changed, or that changing a regulation caused anything, your question is moot.

They must be if it is "less" regulation. It can't be "less" if there weren't changes to regulations. The regulations for this have been the same for a while, they aren't "less" than before.

 

[Guns Guns Guns]

I see, so when you claim it is "less regulation in action" you are now claiming that it wasn't "less regulation" that caused it?

That's right.

Inane, it is simply a way to stress the meaning in conversational English. A sad attempt to distract from the discussion.

According to you.

So you now understand that she does enact regulation and that the lack thereof could indeed have been filled through efforts of the Administration?

"Could have been"? LOL.

In what way? If it is "less" then it is clear you believe that "more" would fix it, what regulation do you believe would have stopped this from happening?

Non sequitur. On the basis of the facts, you have no reason to think I beleive that, do you?

That is up for debate, according to your originating article. If you believe that more regulation of this industry is the answer, then why are you not asking Obama to work towards regulating compounding pharmacies rather than blaming people who cannot?

When did I say "more regulation of this industry is the answer"? Your premise continues to be false.

They must be if it is "less" regulation. It can't be "less" if there weren't changes to regulations. The regulations for this have been the same for a while, they aren't "less" than before.

The compound pharmacy business can be less-regulated than other industries.

And it is.

 

[Damocles]

That's right.



According to you.



"Could have been"? LOL.



Non sequitur. On the basis of the facts, you have no reason to think I beleive that, do you?



When did I say "more regulation of this industry is the answer"? Your premise continues to be false.



The compound pharmacy business can be less-regulated than other industries.

And it is.

Your reasoning is circular.

You suggest that this was caused by less regulation, but somehow not, that you do not think more regulation would fix it yet less caused it... Round and round we go.

I've wasted my time, this is nonsense from beginning to end.

 

[Guns Guns Guns]

Your reasoning is circular.

No, it isnt.

You suggest that this was caused by less regulation...

No, I don't.

I've wasted my time, this is nonsense from beginning to end.

Don't go away mad.

 

[Damocles]

No, it isnt.

It is.

No, I don't.

You do, it is the basis of your title.

Don't go away mad.

I'm not "mad".

 

[Guns Guns Guns]

What do we know about compounding pharmacies?


They mix solutions from powder and other ingredients to make medicines.


They are not subject to oversight by the U.S. Food and Drug Administration (FDA).


Compounding pharmacies become essentially mini-pharmaceutical companies that fill the gap in drug back orders.


With more than 7,500 in the U.S., they account for 3 percent of all prescriptions...



http://www.searcymasstort.com/blog/2012/10/10/compounding-pharmacies-an-unregulated-minefield/

 

[canceled.2021.1]

What do we know about compounding pharmacies?


They mix solutions from powder and other ingredients to make medicines.


They are not subject to oversight by the U.S. Food and Drug Administration (FDA).


Compounding pharmacies become essentially mini-pharmaceutical companies that fill the gap in drug back orders.


With more than 7,500 in the U.S., they account for 3 percent of all prescriptions...



http://www.searcymasstort.com/blog/2012/10/10/compounding-pharmacies-an-unregulated-minefield/

You are wrong and are completely uninformed. Thisnis what happens when someone like you who lives in his mama's basement just gets information from doing a google search. Stop embarrassing yourself

 

[Guns Guns Guns]

You are wrong and are completely uninformed. Thisnis what happens when someone like you who lives in his mama's basement just gets information from doing a google search. Stop embarrassing yourself

What have I presented that is"wrong"?

Be specific.

 

[canceled.2021.1]

What have I presented that is"wrong"?

Be specific.

You aren't presenting anything you know from experience or personal knowledge but just cutting and pasting. As I said you don't know what you are talking about. Just because you read an online article doesn't mean you understand or have the depth of knowledge to know if it is right or not. It is clear you do not.

This is why you blindly follow Obama

 

[Guns Guns Guns]

You aren't presenting anything you know from experience or personal knowledge but just cutting and pasting. As I said you don't know what you are talking about. Just because you read an online article doesn't mean you understand or have the depth of knowledge to know if it is right or not.

Are you claiming that unsupported anecdotal claims are superior to citing reports from verifiable sources verbatim?

Didn't you say I was "wrong and completely uninformed"?

Weren't you asked to produce specific facts that proved that assertion?

Yet you didn't, did you?

How come?

It is clear you do not.

I don't? How is it "clear"?

Be specific.

This is why you blindly follow Obama

I do?

How do you know that?

Be specific.