Posted on 08/17/2011 9:31:27 PM PDT by neverdem
“it is a violation of federal law to use this product in any manner not intended by the manufacturer”.
You see this warning on everything.
It also applies to drugs, it’s illegal to use a drug for another purpose with it first being approved for that purpose again, after new clinical trials.
No it's not, or physicians would be getting fined or prosecuted left and right for off label indications. It happens all the time. Eventually, they get FDA approval to put a new indication on the label after FDA testing.
How would it be discovered if it was illegal? The pharmacist doesn't know why the drug is being prescribed. If the drug works, the patient gets better.
It most certainly IS illegal, just not usually prosecuted at the moment.
Another of those wonderful federal laws that is selectively enforced.
A change in Fed. regulatory agency personnel, focus, definition of the crime, a determination to levy fines for revenue, all sorts of minor changes could result in the law suddenly being enforced.
Here we are in the 21st century, and here you are advocating trial and error to replace science.
No thanks.
Physicians and drug manufacturers get prosecuted left and right for ON LABEL INDICATIONS !
Off label indication abuse gets them disbarred and sent to jail.
MDs can go off label as they wish.
I found this in Wikipedia, which supports my position on off-label drug use:
"The FDA approves a drug for prescription use, and will continue to regulate the pharmaceutical industry through the work of the Division for Drug Marketing, Advertisement and Communication (DDMAC).[3] The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off label, including controlled substances such as opiates. Actiq, for example, is commonly prescribed off label even though it is a Schedule II controlled substance. While it would be legal for a physician to independently decide to prescribe a drug such as Actiq off-label, it is illegal for the company to promote off-label uses to prescribers. In fact, Cephalon, the maker of Actiq, was fined for illegal promotion of the drug in September 2008.[4] Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing a drug for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request. 21 U.S.C. §360aaa-6.
So, since Wikipedia is not invariably correct, possibly you could discussed a prosecution of off label prosecution? Or of a doctor being "disbarred" and sent to jail for it? Any incident?
Correction of my previous post:
So, since Wikipedia is not invariably correct, possibly you could discuss a sample prosecution of off label prescription? Or of a doctor being “disbarred” and sent to jail for it? Any incident?
Nope. Wrong. It’s legal for a doctor to prescribe a drug for off label use, it is NOT legal for the drug manufacturer to advertise the drug for off label use, although it may provide the physician with information about off label use under certain circumstances.
I am neither a doctor or lawyer, but I am very familiar with selective prosecution.
What may be being “Allowed” is not necessarily the same as “Completely Legal”.
As I said, a change in the enforcement winds may have drastic effects on this practice.
Try getting any Fed. agency to bless it in writing.
This statement of yours:
“...it’s illegal to use a drug for another purpose with it first being approved for that purpose again, after new clinical trials.”
is wrong.
Well, I take that as fact from numerous prior articles on the subject which also stated so.
The contention that new clinical trials are required before being prescribed for new uses has been made many times, by medical writers.
So your contention is that they are also ALL wrong.
Not a major issue for me, I don’t write prescriptions.
I believe that the intent of the article (study) is to encourage drug manufactures not doctors to explore new uses of existing approved drugs to fight diseases that those drugs are not currently approved to treat.
The drugs then could be more quickly approved for the new uses because of preexisting data on their side effects and safety.
Since you don’t write prescriptions, I would not expect you to have any kind of accurate knowledge about off label use.
I work for a Big Pharma company. All I can say is you couldn't be more wrong if you tried.
No thanks.
onona made that comment, not me.
Clinical studies are trial and error because species are different. It's smarter to check drugs in lower forms of life before human clinical trials. These two studies reported the results of computational bio-informatics on genetic/genomic signalng pathways. It was hardly trial and error.
Popular Herbal Supplements May Adversely Affect Chemotherapy Treatment
Switch in cell's 'power plant' declines with age, rejuvenated by drug
MicroRNA in TLR signaling and endotoxin tolerance
FReepmail me if you want on or off my health and science ping list.
Thanks.
I like this. These older drugs should be relatively inexpensive and they have a track record.
http://www.firstwordpharma.com/node/881520
http://www.firstwordplus.com/msl_kol_engagement_ensuring_compliance.do
Hope the links work for you !
Big difference.
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