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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 6 of 6. This is the beginning of the thread.
Posted by Phillipa on January 14, 2009, at 12:50:06
Thought this was interesting Now it's okay. Phillipa
U.S. Lets Drugmakers Advise Doctors on Unapproved Uses
By Lisa RichwineWASHINGTON (Reuters) Jan 12 - U.S. officials finalized controversial guidelines that will allow pharmaceutical companies and medical device makers to tell doctors about unapproved uses of their products.
The Food and Drug Administration (FDA) will permit manufacturers such as Pfizer Inc and Merck & Co to distribute copies of medical journal articles that describe unapproved uses. The practice could help companies expand the markets for medicines and medical devices.
The move, announced a week before Republican President George W. Bush leaves office, enacts 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 will promote untested uses of drugs and may be dangerous for patients. It also could deter manufacturers from conducting additional tests of the new uses and subjecting them to FDA scrutiny for possible approval.
Off-label use is common in medicine. 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. The agency also said it encouraged companies to seek FDA approval for unapproved uses.
(Reporting by Lisa Richwine; editing by Derek Caney and Brian Moss)
Posted by linkadge on January 14, 2009, at 20:15:16
In reply to FDA Gives Approval For Off Label Use Of Meds., posted by Phillipa on January 14, 2009, at 12:50:06
Seems like a couple years back they were reprimanding companies for doing this very thing.
Linkadge
Posted by Phillipa on January 14, 2009, at 21:17:36
In reply to Re: FDA Gives Approval For Off Label Use Of Meds., posted by linkadge on January 14, 2009, at 20:15:16
I know guess the drug companies convinced the FDA they needed more money or something who knows? Love Phillipa
Posted by seldomseen on January 15, 2009, at 2:02:49
In reply to Re: FDA Gives Approval For Off Label Use Of Meds. » linkadge, posted by Phillipa on January 14, 2009, at 21:17:36
Actually, while this may make big pharma some more money, it will likely be of most benefit to the patient.
If these drugs have received FDA approval, then they have been through some safety testing. This significantly expedites, but does not completely eliminate the process of safety and efficacy testing in another disease state.
Also note, that the text did not say that the companies could actively *market* off label use of the drugs, but could distribute studies in which the drug has been tested off label.
Remember, Provigil was/is prescribed off label.
Though the article states otherwise, physicians do come under some liability when they prescribe a drug off label as it goes against the intended use for the drug.
Some medical journals even today will not publish studies that investigate off-label use of drugs.
I think this is a step in the right direction and will bring new therapies to old problems.
Seldom
Posted by Phillipa on January 15, 2009, at 20:12:57
In reply to Re: FDA Gives Approval For Off Label Use Of Meds. » Phillipa, posted by seldomseen on January 15, 2009, at 2:02:49
Is that the reason my internist said that's the site he reads on the internet WebMD? So I used my nursing license number and joined and get articles intented only for MD's pharmacists, and Nurses. Great article on the reasons nurses older ones and even younger ones are getting out of nursing. Long hours and shifts. Too much paperwork also. So I guess the site is a pretty arcurate one. Also can get credits on it for licensure. Thanks for answering. Love Phillipa
Posted by yxibow on January 16, 2009, at 3:45:29
In reply to Re: FDA Gives Approval For Off Label Use Of Meds. » seldomseen, posted by Phillipa on January 15, 2009, at 20:12:57
This is absolutely bizarre considering the 1.42 billion dollar settlement with Eli Lilly.
Now I'm not going to go into the perfectly good offlabel uses of Zyprexa and other agents which have been extremely beneficial to people, but its the marketing offlabel that I consider a travesty.
Only trained psychopharmacologists who have seen enough in evidence based psychiatry should be making these decisions.
This is the end of the thread.
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