You are not going to believe what the FDA is trying to pull now....

[tangent4ronpaul]

http://www.fdalawyersblog.com/2011/01/grandfathered-morphine-policy.html

Cody/Lannett originally complained following FDA's issuance of a 2006 Compliance Policy Guidance. The guidance stated that the grandfathering provisions of the Food Drug and Cosmetic Act ("FD&C Act") of 1938, as amended in 1962, no longer applied to thousands of "unapproved drugs" being sold in the United States, including Cody/Lannett's morphine sulfate. FDA determined that unapproved drugs were now subject to enforcement action as unapproved "new drugs" without any regard to the length of time a particular drug had been in use or the indications for or labeling of such drugs prior to 1938

http://pharmrep.findpharma.com/pharmrep/News+Analysis/FDA-Demands-Pharma-Firms-Pull-Unapproved-Drugs/ArticleStandard/Article/detail/591466

“When we started the initiative we estimated that approximately 2 percent of prescriptions filled in the United States were marketed, unapproved drugs,” Levy told Pharm Exec on Wednesday. “So it’s a significant number of products that are out there.”

Since that time, FDA has taken approximately 500 unapproved drugs off drugstore shelves. Levy said that FDA is also contacting pharmacies and distributors, and training them to look for FDA approval labels when considering purchasing product or filling a prescription.

==
Please keep in mind that it now takes up to 12 years to get a "new" drug approved and costs between 750 Million and 1.2 Billion.

There are over 2,000 drugs that are "unapproved".

This is a disaster!

[Anti Federalist]

Another salvo in the "War on Pain" wrt to the morphine sulfate

God help you in this country if you are suffering from chronic pain.

Basically, government's response to you is, suffer and die.

[tangent4ronpaul]

It isn't so much about pain - though there are a handful of pain meds that are included. Worry more about the other 2,000+ drugs that are "unapproved".

The judge in the morphine case basically ruled that he had no authority to rule on a regulatory approval rule. IE: unelected bureaucrats are GOD and completely unaccountable.

If these drugs do get approved, their cost will go up 10-100x as they will now be under patent and BigPharm will want it's money back for the approval process. (plus mega profit for the trouble) Think what that is going to do to the costs of the health care system?

This is about as big as banning vitamins without a Rx because of the universal codex.

The desire for power and control as well as greed (it's a resolving door between the FDA and Big Pharma) could easily crash our medical system - not to mention economy.

-t

[Anti Federalist]

Agreed, I just wanted to bring up the chronic pain angle once again, since the feds just raided a whole mess of doctors and pharmacies in Florida a few days ago.


It isn't so much about pain - though there are a handful of pain meds that are included. Worry more about the other 2,000+ drugs that are "unapproved".

The judge in the morphine case basically ruled that he had no authority to rule on a regulatory approval rule. IE: unelected bureaucrats are GOD and completely unaccountable.

If these drugs do get approved, their cost will go up 10-100x as they will now be under patent and BigPharm will want it's money back for the approval process. (plus mega profit for the trouble) Think what that is going to do to the costs of the health care system?

This is about as big as banning vitamins without a Rx because of the universal codex.

The desire for power and control as well as greed (it's a resolving door between the FDA and Big Pharma) could easily crash our medical system - not to mention economy.

-t

[Yieu]

Another salvo in the "War on Pain" wrt to the morphine sulfate

God help you in this country if you are suffering from chronic pain.

Basically, government's response to you is, suffer and die.

This is true.