FDA not approving new Big Pharma products

[Anonymous]

Pristiq VMS approved in Europe, denied twice in US.

And today...
Merck & Co. failed to win U.S. approval of an oral contraceptive already sold in Europe and a glaucoma treatment on the market in nine countries.

http://www.bloomberg.com/news/2011-...d-to-win-u-s-approval-for-two-treatments.html

 

[Anonymous]

Vioxx/Bextra slap back!

 

[Anonymous]

What's new? Isn't it great that your government can kill its people in so many "legal" ways by prohibiting new drugs from coming to market?

I'm certain Thomas Jefferson is turning over in his grave drafting the sentence "Congress Shall Regulate Commerce" would be so incredibly abused and intentionally misinterpreted.

How does an executive branch bureaucracy totally control commerce with regards to medicine? You answer that one and fix it, it will almost fix our country.

 

[Anonymous]

What's new? Isn't it great that your government can kill its people in so many "legal" ways by prohibiting new drugs from coming to market?

I'm certain Thomas Jefferson is turning over in his grave drafting the sentence "Congress Shall Regulate Commerce" would be so incredibly abused and intentionally misinterpreted.

How does an executive branch bureaucracy totally control commerce with regards to medicine? You answer that one and fix it, it will almost fix our country.

It's called protecting the health and safety of the American public. The pharma industry created the regulatory headwinds that they face today b/c of the ethical lapses of the past. I'm all for companies making a profit, but not at the expense of patient safety. Maybe this will force pharma to develop medicines that are both safe and vastly superior to existing medicines. It no longer makes financial sense to pay a premium for only marginal improvements to existing medications.

I'm sorry that the pharma rep gravy train is over for you.

 

[Anonymous]

It's called protecting the health and safety of the American public. The pharma industry created the regulatory headwinds that they face today b/c of the ethical lapses of the past. I'm all for companies making a profit, but not at the expense of patient safety. Maybe this will force pharma to develop medicines that are both safe and vastly superior to existing medicines. It no longer makes financial sense to pay a premium for only marginal improvements to existing medications.


"I'm sorry that the pharma rep gravy train is over for you."

No you're not, and No it's not.

 

[Anonymous]

It's called protecting the health and safety of the American public. The pharma industry created the regulatory headwinds that they face today b/c of the ethical lapses of the past. I'm all for companies making a profit, but not at the expense of patient safety. Maybe this will force pharma to develop medicines that are both safe and vastly superior to existing medicines. It no longer makes financial sense to pay a premium for only marginal improvements to existing medications.

I'm sorry that the pharma rep gravy train is over for you.

And European socialist healthcare countries who approved these drugs on the global market do not commit to safety and comparative advantage approvals?

Approving medicines "vastly superior to existing medicines" in not the FDA mandate. It's safe and effective, as congress passed. If the former is the case, FDA is violating federal law.

 

[Anonymous]

And European socialist healthcare countries who approved these drugs on the global market do not commit to safety and comparative advantage approvals?

Approving medicines "vastly superior to existing medicines" in not the FDA mandate. It's safe and effective, as congress passed. If the former is the case, FDA is violating federal law.

Exactly, you nailed it. The libidiots keep thinking their Dear Leaders are always looking out for them, the People.

The system as designed by the Constitution easily handles the "ethical lapses" safety argument proffered and religiously adhered to by the libidiots. The criminal courts and civil courts are more than sufficient to redress any and all wrongs perpetuated by a rogue pharma company or drug maker. Yet the executive branch creates its own buracracy to stifle medical progress and hold all of hostage under their thumbs instead of letting the market forces and the originally devised government work.

But hey, who cares right? Life is good, nothing bad can come of this, right? Just let big brother do everything and sit back and relax. Good sheeple.

 

[Anonymous]

What's new? Isn't it great that your government can kill its people in so many "legal" ways by prohibiting new drugs from coming to market?

I'm certain Thomas Jefferson is turning over in his grave drafting the sentence "Congress Shall Regulate Commerce" would be so incredibly abused and intentionally misinterpreted.

How does an executive branch bureaucracy totally control commerce with regards to medicine? You answer that one and fix it, it will almost fix our country.

Richard M Nixon!

 

[Anonymous]

What's new? Isn't it great that your government can kill its people in so many "legal" ways by prohibiting new drugs from coming to market?

I'm certain Thomas Jefferson is turning over in his grave drafting the sentence "Congress Shall Regulate Commerce" would be so incredibly abused and intentionally misinterpreted.

How does an executive branch bureaucracy totally control commerce with regards to medicine? You answer that one and fix it, it will almost fix our country.

You are such an idiot. Our industry routinely submits drugs that are only 5% more effective than a placebo and we routinely submit drugs with side effects that are as bad or worse than the condition we claim to be curing. It wasn't that long ago that Forrest Labs was caught submitting a pediatric application for one of their drugs when they had data to show it was worse than the placebo. Guess you've conveniently forgotten that one. Our industry leaders don't give a damn about healing or curing anyone. They just want to make LOTS OF MONEY. Every American business is like that. They just want to make LOTS OF MONEY. Because American business is so abusive at every opportunity we need lots of legulations to protect us!!!!!!!!!!!!!

 

[Anonymous]

You are such an idiot. Our industry routinely submits drugs that are only 5% more effective than a placebo and we routinely submit drugs with side effects that are as bad or worse than the condition we claim to be curing. It wasn't that long ago that Forrest Labs was caught submitting a pediatric application for one of their drugs when they had data to show it was worse than the placebo. Guess you've conveniently forgotten that one. Our industry leaders don't give a damn about healing or curing anyone. They just want to make LOTS OF MONEY. Every American business is like that. They just want to make LOTS OF MONEY. Because American business is so abusive at every opportunity we need lots of legulations to protect us!!!!!!!!!!!!!

Medical innovation is incremental, not quantum.

It's like the difference between getting an iPhone4 and an iPhone S, whether you buy it from Company A, Company V or Company S.

Other industries are no different.

 

[Anonymous]

You are such an idiot. Our industry routinely submits drugs that are only 5% more effective than a placebo and we routinely submit drugs with side effects that are as bad or worse than the condition we claim to be curing. It wasn't that long ago that Forrest Labs was caught submitting a pediatric application for one of their drugs when they had data to show it was worse than the placebo. Guess you've conveniently forgotten that one. Our industry leaders don't give a damn about healing or curing anyone. They just want to make LOTS OF MONEY. Every American business is like that. They just want to make LOTS OF MONEY. Because American business is so abusive at every opportunity we need lots of legulations to protect us!!!!!!!!!!!!!

You proved how idiotic you are. Thanks.

We do not need an FDA to approve drugs. We need a Constitutional government to severely punish those whom intentionally or recklessly harm others. Since our original government has been bastardized by federalist libtards, we have now a huge quagmired clusterfuck of governmental REGULATIONS. They do nothing but prevent progress and innovation.

Many beloved companies by your lovely FDA have drugs and new indications approved even though they did worse than or equal to placebo. It's all about favoritism and corruption with your Big Government, thereby preventing progress in medicine.

Keep singing the libidiot song that Big brother is here and should be neck deep in everyone's lives for their own good and for our "safety". You'd think that you useful idiots would wise up after seeing how any form of leftism is an absolute failure, but nope, you sing its high praises. No wonder why liberalism is a certified mental disorder.

 

[Anonymous]

You proved how idiotic you are. Thanks.

We do not need an FDA to approve drugs. We need a Constitutional government to severely punish those whom intentionally or recklessly harm others. Since our original government has been bastardized by federalist libtards, we have now a huge quagmired clusterfuck of governmental REGULATIONS. They do nothing but prevent progress and innovation.

Keep singing the libidiot song that Big brother is here and should be neck deep in everyone's lives for their own good and for our "safety". You'd think that you useful idiots would wise up after seeing how any form of leftism is an absolute failure, but nope, you sing its high praises. No wonder why liberalism is a certified mental disorder.

Dude. Did you not read Upton Sinclair's "The Jungle" about the time you were beating up kids on the playground?. I'm glad it led to the passage of the Meat Inspection Act and the Pure Food and Drug Act. I guess you think that safe food is unnecessary "safety", and by extension, medical modalities. Are you a Contard?

 

[Anonymous]

Dude. Did you not read Upton Sinclair's "The Jungle" about the time you were beating up kids on the playground?. I'm glad it led to the passage of the Meat Inspection Act and the Pure Food and Drug Act. I guess you think that safe food is unnecessary "safety", and by extension, medical modalities. Are you a Contard?

Thanks for the libtard, snobby literature braggadocia, half assed history lesson. Typical retort from an elitist leftard.

You still and never will get it. You religiously believe the government is your cure all for all of society's issues. No matter how much common sense and intellectual information is thrown at you, you refuse to absorb any of it.

Enjoy your big brother enslavement. I don't.

I wished a playground bully knocked sense into you before you turned into such a dangerous useful idiot.

 

[Anonymous]

Dude. Did you not read Upton Sinclair's "The Jungle" about the time you were beating up kids on the playground?. I'm glad it led to the passage of the Meat Inspection Act and the Pure Food and Drug Act. I guess you think that safe food is unnecessary "safety", and by extension, medical modalities. Are you a Contard?

It's not 1906 anymore.

 

[Anonymous]

You are such an idiot. Our industry routinely submits drugs that are only 5% more effective than a placebo and we routinely submit drugs with side effects that are as bad or worse than the condition we claim to be curing. It wasn't that long ago that Forrest Labs was caught submitting a pediatric application for one of their drugs when they had data to show it was worse than the placebo. Guess you've conveniently forgotten that one. Our industry leaders don't give a damn about healing or curing anyone. They just want to make LOTS OF MONEY. Every American business is like that. They just want to make LOTS OF MONEY. Because American business is so abusive at every opportunity we need lots of legulations to protect us!!!!!!!!!!!!!

Interesting insight - well thought out counterpoint.

 

[Anonymous]

Interesting insight - well thought out counterpoint.

Please don't respond to your post.

 

[Anonymous]

Please don't respond to your post.

Wasn't my post. And wow did I strike a nerve. Chill & take the day off. Or for a change - go out and work a full day.

 

[Anonymous]

Thanks for the libtard, snobby literature braggadocia, half assed history lesson. Typical retort from an elitist leftard.

You still and never will get it. You religiously believe the government is your cure all for all of society's issues. No matter how much common sense and intellectual information is thrown at you, you refuse to absorb any of it.

Enjoy your big brother enslavement. I don't.

I wished a playground bully knocked sense into you before you turned into such a dangerous useful idiot.

Dude, why are you harshing me? I'm a fellow traveller, I will be voting Republican. Your drunken rants give conservatives a bad reputation. Get some sleep and cut down on the sauce. Did you lose your job?

 

[Anonymous]

Wasn't my post. And wow did I strike a nerve. Chill & take the day off. Or for a change - go out and work a full day.

Clearly, the nerve hit was you. And your assumption is false.

 

[Anonymous]

Pristiq VMS approved in Europe, denied twice in US.
Merck & Co. failed to win U.S. approval of an oral contraceptive already sold in Europe and a glaucoma treatment on the market in nine countries.
[/QUOTE

Incredibly poor documentation submitted to the FDA. Worthless QA. Merck has few professional employees remaining. Stupid management.