Monday, January 12, 2009

huge news....

U.S. lets drugmakers advise doctors on unapproved uses
Mon Jan 12, 2009 5:53pm EST
By Lisa Richwine

WASHINGTON (Reuters) - U.S. health officials finalized guidelines that allow pharmaceutical companies to tell doctors about unapproved uses of their medicines, a practice opposed by critics of industry marketing.
The Food and Drug Administration (FDA) guidelines allow manufacturers such as Pfizer Inc and Merck & Co to distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.
The move, announced a week before Republican President George W. Bush leaves office, puts in place a policy that drew objections from congressional Democrats and drug-industry critics when it was proposed last year. Opponents say it will allow promotion of uses without adequate testing.
By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for any use they see fit, a practice known as "off-label" use.
Distribution of medical literature suggesting a drug may have merit for an unapproved use is a marketing area that has been in dispute for years.
The FDA said "public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses."
Industry critics say allowing companies to distribute the information promotes untested uses of drugs and may be dangerous. It also could deter manufacturers from conducting additional tests of the new uses and subjecting them to FDA scrutiny for possible approval.
Consumer advocate Sidney Wolfe said the guidelines were only recommendations to companies, rather than a formal regulation, and should be reversed quickly after Democrat Barack Obama becomes president next week.
Off-label use "means there isn't adequate evidence that the benefits outweigh the risks to have it approved by the FDA," said Wolfe, director of Public Citizen's Health Research Group. Companies may use off-label promotion "as a way of avoiding having the drug approved" for wider use, he said.
Giving medicines for unapproved uses is common. A doctor may prescribe an antidepressant, for example, to treat insomnia, or a cancer drug for a type of cancer beyond what is approved.
About one of five prescriptions in the United States was written to treat a condition for which the drug was not approved, according to a 2006 study published in the Archives of Internal Medicine. The researchers said most off-label use occurs without scientific support.
Drugmakers welcomed the new FDA guidelines. Providing the studies to doctors will help "assure that medical professionals receive timely and accurate medical information prior to the lengthy process" of securing FDA approval for wider use, said Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America.
Off-label use "can save lives, especially in practice areas where there are few effective treatments," he added.
The FDA said articles circulated by companies should come from peer-reviewed journals that require disclosure of conflicts of interest for researchers. It also encouraged companies to seek FDA approval for unapproved uses.
The guidelines also apply to medical device makers.
The FDA proposed the guidelines in February 2008 and took public comments before finalizing them.
(Reporting by Lisa Richwine; editing by Derek Caney, Brian Moss, Leslie Gevirtz)


  1. OK, someone help me out here....

    On the one hand, Bush, Troy, and pals support preemption - no states can "second guess" the FDA re: approved uses, warnings, delivery systems (as in Levine), etc.

    On the other hand, companies can promote uses that FDA may have never considered at all, and certainly not approved.

    So is this the logic: FDA preempts the states. But companies preempt the FDA.

    This is likely to end up in a big ball of....Waxman.

  2. Approval of unapproved uses. Say it again. Approval of unapproved uses. Still doesn't make sense. It's OK if you do what we told you not to do.
    This is from a Federal regulating body.
    Please Lord keep me healthy.

  3. Well, here will be the rationale.....

    FDA had an earlier "rule" (more like a guideline), that said reps could give peer-reviewed studies to docs concerning unapproved uses. That apparently expired in 2006, and Congress has been against its renewal.

    The administration went ahead anyway. But the difference is that, under the old rule, companies had to submit to FDA the studies they intended to use for promo beforehand. Now they don't.

    So I think that brings us back to the conclusion above: Companies preempt the FDA, and the FDA is in no position to second-guess what a company decides to do.

    The Mad Hatter will be meeting with everyone at 4:00....Don't be late.

  4. The Mad Hatter reminds me ... All drugs have dangers. Even hats have dangers. Especially in DC.

  5. I couldn't believe it when I heard this story. Is this some kind of thanks guys its been great goodbye gift?

  6. That's great news! Doctors should be given the latest and most relevant research about drugs. This is especially important in the case of rare (orphan) diseases where there are no good alternative treatments. It's incredibly important that doctors be aware of new uses for approved drugs. (As part of this, I also believe that it is critically important that the doctor INFORM the patient that the drug is being prescribed for an unapproved use)

  7. Nathan, Doctors already know about and use drugs "off label". This legislature acknowledges this and condones it. This is again some more legal wrangling. Who does the patient sue when they are hurt by this? Ooops, wait, they don't sue - we are moving towards a "no-fault" health care system.

    In that case, if you get sick, you can decide if you want to be part of the medical health care system and treated by doctors who have now been turned into a bunch of charlatans, thanks to all these new "bye-bye - so long, it's been fun being a republican gifts being handed out in Washington these days (can inauguration day come any sooner?) or do you put your faith in natural health cures. Might as well do the former because thanks to the idiots in Washington these past eight years everything is becoming a sham!

    And that is just maddening. I really hope the Democrats can clean this mess up and give us back our integrity, credibility and innovative leadership. The Pharma industry has a new chance to become the leaders they were. But let's wait and see!

  8. FPME writes: "Nathan, Doctors already know about and use drugs off label".

    Sure, if you are lucky enough to visit a doctor who actively keeps up with the primarly medical literature, then you are correct -- this legislation does nothing. If you happen to visit one of the other 90% of the doctors who do not keep up with medical literature, then this measure at least allows the distribution of relevant peer-reviewed publications to doctors who may not be aware of newer studies.

    If you trust your doctor, then there is no reason to fear the distribution of scientific articles. If you do not trust your doctor, then you have bigger things to fear than the distribution of medical literature. This is a no-brainer: More information is always better than less information.


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