Less government regulation in action

[Guns Guns Guns]

The nation’s growing outbreak of meningitis, linked to spinal injections for back pain, was a calamity waiting to happen — the result of a lightly regulated type of drug production that had a troubled past colliding with a popular treatment used by millions of Americans a year.



The steroid solution was not made by a major drug company, but was concocted by a pharmacy in Framingham, Mass., called the New England Compounding Center.


Compounding pharmacies make their own drug products, which are not approved by the Food and Drug Administration.


On Monday, federal inspectors at the New England center found a sealed vial of the steroid afloat with so much foreign matter that it could be seen with the naked eye, Food and Drug Administration officials said...



Pharmacies and regulators have struggled for years over what limits to set on the practice. Compounding has fallen between state and federal authorities, and the legal status of compounded drugs has never been clear.



Compounding is tolerated by the F.D.A., as long as the pharmacy does not ship across state lines, mass produce drugs or use commercial scale equipment, said James H. Ruble, an assistant professor at the University of Utah College of Pharmacy.



But recent court cases, including one in federal court in Florida, have raised questions about the F.D.A.’s authority.


In a case involving a compound-maker called Franck’s that was producing compounds for veterinary use, a judge ruled that the F.D.A. could not assume it had authority to regulate compounding pharmacies....




http://www.nytimes.com/2012/10/05/h...oversight-on-compounding-pharmacies.html?_r=0

 

[canceled.2021.1]

how many products are compounded this way by pharmacies a year and how many result in this sort of tragedy?

What kind of regulation do you propose?

I can't wait to hear a prole like you discuss the practice of pharmacy for which there is plenty of regulation

 

[NOVA]

how many products are compounded this way by pharmacies a year and how many result in this sort of tragedy?

What kind of regulation do you propose?

I can't wait to hear a prole like you discuss the practice of pharmacy for which there is plenty of regulation

You can't tell whats gonna happen under this failures watch....

 

[Guns Guns Guns]

We need less government, right, conservatives?

Industry can be trusted to regulate itself, can't it?

 

[Timshel]

You can't tell whats gonna happen under this failures watch....

OMG, that is stupider than the op which was pretty dumb. Was the 2003 complaint against this lab, while Romney was governor, his fault or Bush's?

They are Massholes. Enough said.

 

[Timshel]

We need less government, right, conservatives?

Industry can be trusted to regulate itself, can't it?

We don't have a market based regulation system in place for this. The government system failed and apparently is not clear.

 

[NOVA]

OMG, that is stupider than the op which was pretty dumb. Was the 2003 complaint against this lab, while Romney was governor, his fault or Bush's?

They are Massholes. Enough said.

The people are fuckin' DEAD under Obamas watch......enough said.

I don't want to be accused of feeding the asshole troll....

 

[Guns Guns Guns]

We don't have a market based regulation system in place for this. The government system failed and apparently is not clear.

Guess you didn't read the OP. Laissez-faire is the current state of affairs, and lack of regulatory authority is the status quo.

Don't conservatives want less regulation of businesses like compounding pharmacies?

 

[Guns Guns Guns]

The people are fuckin' DEAD under Obamas watch......enough said.

I don't want to be accused of feeding the asshole troll....

So Obama caused the pharmacy to escape government regulation in 2002 and 2003, Blabo?

The New England center has had a long history of problems. Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Department of Public Health, said there had been three complaints registered against it, in 2002, 2003, and this year in March, when the potency of a compound used in eye surgery was questioned. Its ability to perform sterile processing was also questioned.

http://www.nytimes.com/2012/10/05/h...oversight-on-compounding-pharmacies.html?_r=0

Poor Blabo.

 

[Timshel]

Guess you didn't read the OP. Laissez-faire is the current state of affairs, and lack of regulatory authority is the status quo.

Don't conservatives want less regulation of businesses like compounding pharmacies?

That is not the status quo. The article clearly states that the regulatory authority of the FDA is uncertain.

...

But recent court cases, including one in federal court in Florida, have raised questions about the F.D.A.’s authority. In a case involving a compound-maker called Franck’s that was producing compounds for veterinary use, a judge ruled that the F.D.A. could not assume it had authority to regulate compounding pharmacies, Professor Ruble said. That case is on appeal.

...

I am not sure how you avoided it bravo, but, alright, I will quit feeding him.

 

[Don Quixote]

it looks like another hole in the regulatory system has been found and exploited

my wife has to use a compounded medication because the fda approved medication uses milk sugar as an excipient and she is lactose intolerant

milk sugar (lactose) is a common excipient in many pills, but because it is an 'inert' ingredient the manufacturer does not have to disclose that it is used

it is most commonly found in generic medications because it is cheaper than other excipients

excipient /ex·cip·i·ent/ (ek-sip´e-int) any more or less inert substance added to a drug to give suitable consistency or form to the drug; a vehicle.
Dorland's Medical Dictionary for Health Consumers. © 2007 by Saunders, an imprint of Elsevier, Inc. All rights reserved.


(from wikipedia)
[h=4]Lactose in non-dairy products[/h]Lactose (also present when labels state lactoserum, whey, milk solids, modified milk ingredients, etc.) is a commercial food additive used for its texture, flavour and adhesive qualities, and is found in foods such as processed meats[SUP][35][/SUP] (sausages/hot dogs, sliced meats, pâtés), gravy stock powder, margarines,[SUP][36][/SUP] sliced breads,[SUP][37][/SUP][SUP][38][/SUP] breakfast cereals,potato chips,[SUP][39][/SUP] processed foods, medications, pre-prepared meals, meal replacement (powders and bars), protein supplements (powders and bars) and even beers in the milk stout style. Some barbecue sauces and liquid cheeses used in fast-food restaurants may also contain lactose.
Kosher products labeled pareve or fleishig are free of milk. However, if a "D" (for "Dairy") is present next to the circled "K", "U", or other hechsher, the food likely contains milk solids,[SUP][35][/SUP] although it may also simply indicate that the product was produced on equipment shared with other products containing milk derivatives.

Lactose intolerance means that you cannot digest foods with lactose in them. Lactose is the sugar found in milk and foods made with milk. After eating foods with lactose in them, you may feel sick to your stomach. You may also have

• Gas
• Diarrhea
• Swelling in your stomach

 

[Guns Guns Guns]

And yet, conservatives continue to assure us that wholesale deregulation of industry will make us more safe and prosperous?

 

[Timshel]

it looks like another hole in the regulatory system has been found and exploited

Exactly.

I am sure you know what would happen if every time your wife's medication was prepared it had to be approved by the FDA.

 

[Don Quixote]

Exactly.

I am sure you know what would happen if every time your wife's medication was prepared it had to be approved by the FDA.

it is prepared at the pharmacy and therefore not subject to federal control

since ca is a civilized state, state regulations control compounding pharmacies...and are enforced

however, if pharmacological manufacturers did not use milk sugar (lactose) she would not have to resort to a compounded prescription

 

[Callinectes]

Why is it that every time something like this happens, the neo-comms automatically assume that conservatives want an end to ALL govt. regulations? What new rules and regulations would you care to put in place that will prevent this sort of thing from ever happening again? What do you want to do? Make illegal things illegaler?

 

[Don Quixote]

Why is it that every time something like this happens, the neo-comms automatically assume that conservatives want an end to ALL govt. regulations? What new rules and regulations would you care to put in place that will prevent this sort of thing from ever happening again? What do you want to do? Make illegal things illegaler?

i do not, i try not to make assumptions

it seems that there are laws, but that they are not sufficiently enforced

this is due to a lack of funding which is the fault of congress...especially the reps in the house that do not like the fda or the epa for that matter or the usda

so next time you get a faulty medication, breath bad air or eat some bad meat or produce...

in some places in the u s of a the water is not fit to drink despite regulations

or rivers, lakes or coastal oceans fit to swim in or the fish therein fit to eat (like sf bay due to mercury pollution)

or sewage plants that break down and spill sewage into the streets or water ways, why because of deferred maintenance

oh well

 

[Timshel]

it is prepared at the pharmacy and therefore not subject to federal control

since ca is a civilized state, state regulations control compounding pharmacies...and are enforced

however, if pharmacological manufacturers did not use milk sugar (lactose) she would not have to resort to a compounded prescription

Apparently, you don't know what would happen.

Your wife might not need compounding if not for the milk sugar, but someone else might.

The state of Massachusetts, obviously, has some sort of regulatory authority over this lab. I am sure California does not approve the result of every compounded medication. To do so would be harmful to those in need of compounded medications.

 

[Timshel]

i do not, i try not to make assumptions

it seems that there are laws, but that they are not sufficiently enforced

this is due to a lack of funding which is the fault of congress...especially the reps in the house that do not like the fda or the epa for that matter or the usda

so next time you get a faulty medication, breath bad air or eat some bad meat or produce...

in some places in the u s of a the water is not fit to drink despite regulations

or rivers, lakes or coastal oceans fit to swim in or the fish therein fit to eat (like sf bay due to mercury pollution)

or sewage plants that break down and spill sewage into the streets or water ways, why because of deferred maintenance

oh well

It is not due to lack of funding. However, in the real world of limited resources and opportunity costs, financing is a legitimate issue.

I cited the passage that highlighted the problem. The regulatory authority is unclear.

You are making assumptions and they contradict the stated facts of this story.

 

[Guns Guns Guns]

Don't conservatives favor less government regulatory control of businesses?

 

[NOVA]

i do not, i try not to make assumptions

it seems that there are laws, but that they are not sufficiently enforced

this is due to a lack of funding which is the fault of congress...especially the reps in the house that do not like the fda or the epa for that matter or the usda

so next time you get a faulty medication, breath bad air or eat some bad meat or produce...

in some places in the u s of a the water is not fit to drink despite regulations

or rivers, lakes or coastal oceans fit to swim in or the fish therein fit to eat (like sf bay due to mercury pollution)

or sewage plants that break down and spill sewage into the streets or water ways, why because of deferred maintenance

oh well

"this is due to a lack of funding which is the fault of congress...especially the reps in the house that do not like the fda or the epa for that matter or the usda"

How long are you gonna parrot this crap....lack of funding, lack of funding, lack of funding, lack of funding, lack of funding, lack of funding,

Failures like this is due to the imbeciles and incompetents that are constantly hired by the government...

It so obvious to anyone that has had to call the VA, Soc. Sec. office, IRS, or even our state DMV's, etc.....

We have to deal with jerks and dopes that don't know what the hell their talking about and give different answers to the identical questions...and
paying them more wont' make them any more intelligent....