Why did the FDA propose making off-label marketing legal?

The FDA just issued a draft guidance allowing drug companies to distribute journal articles that discuss off-label uses of drugs and devices.

Once this is allowed, the door is completely open for drug companies to promote their drugs for anything their heart desire.

Randy Lutter, the FDA’s deputy commissioner, said “articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care. This guidance also safeguards against off-label promotion.”

So why would the FDA suddenly permit off-label marketing? Clearly they are interested in helping someone, and that doesn't appear to be the public. Perhaps the following chart with fines paid by drug companies over the last few years could give a hint?

Schering-Plough	1 280
Bristol Myers Squibb	1 265
Takeda-Abbott	875
Serono	704
Merck	650
GlaxoSmithKline	563
Pfizer	514
Abbot	482
AstraZeneca	355
Bayer	271
Eli Lilly	36
Wyeth	30
Novartis	8
TOTALT	7 033

Pharmalot has a poll about this. Go there and vote.

Dr. Rost is a litigation consultant and pharmaceutical marketing expert. He is also the author of Killer Drug and The Whistleblower. 

Comments

[Scott]

I blame the FDA's user-fee funding for this, which Congress has grown far too reliant on. As Dr. Marcia Angell, a senior lecturer at Harvard Medical School wrote in The Boston Globe, "In effect, the user fee act put the FDA on the payroll of the industry it regulates."

Unfortunately, over the past decade, the FDA has apparently lost sight of the fact that they do not serve the interests of the industries it regulates, they are there to ensure the safety of the nation's food, drug, and medical devices.

As Merrill Goozner wrote:

Note what isn't in the policy: It doesn't say that the studies of unapproved uses must be from randomized controlled clinical trials, which is the gold standard of medical research. All the proposed guidance says is that the studies should be "adequate and well-controlled clinical investigations that are considered scientifically sound by experts with scientific training."

Perhaps its time for Andy Von Eschenbach should step down as some in Congress are now calling for!

[e cig]

I am beginning to really lose all faith and credibility in the FDA. It seems to me that instead of focusing their efforts on protecting the general public they are in-turn being influenced by corporate agenda and special interest. I take everything they say with a grain of salt.

[E Cig]

Why do people care about what the FDA approves or disapproves? it doesn't make any sense to me.

Your girl Mary :)