Boost for Off Label Drug Use

[Celebration]

http://online.wsj.com/article/SB120309931928071945.html?mod=googlenews_wsj

The Food and Drug Administration wants to allow drug companies to give doctors information about unapproved uses of prescription drugs, a controversial move that is already drawing objections from Capitol Hill.

Companies generally aren't allowed to advertise or market such "off-label" uses, though doctors can prescribe drugs for any condition. The FDA has proposed guidelines allowing manufacturers to give physicians reprints of medical journal articles about uses of drugs and medical devices that haven't won the agency's approval.

The regulator is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry -- an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine.

Drug makers are generally expected to welcome the proposal because it clarifies a blurry legal area. At least under certain conditions, it promises a haven for a controversial promotional practice. It also contains an argument from the agency that may help the companies in court cases about marketing practices: There are "important public policy reasons for allowing manufacturers to disseminate truthful and non-misleading medical journal articles" and reference materials about off-label uses.

[Warpy]

1. Off label use results because physicans

alert the FDA and drug manufacturers to unexpected benefits of certain drugs as well as unexpected problems.

I took chemotherapy for five years off label for RA. Now it's also being given to transplant patients and is kinder to their systems than some earlier antirejection drugs. It's also been found useful for MS and asthma.

I also took an antimalaria drug for a total of ten years in two courses. They found that one good for autoimmune diseases, too.

I've also taken antirejection drugs to keep my kidneys from burning out when they were starting to, something that happens once every few years.

Off label uses are out there and they're not all bad. Sometimes they are life savers, helping people stay functional for far longer than they can with standard treatment. That manufacturers are disseminating the articles about off label uses is a good thing. I might be in a wheel chair full time or worse without them.

[Celebration]

2. off label are done all the time

I find this interesting. I don't mind "unproven" (not FDA approved) treatments, so this doesn't really bother me. What will be interesting is seeing how insurance companies react to all this. For expensive drugs they really don't like pharmaceutical treatments that don't match diagnoses.

[Warpy]

3. Those bastards will refuse payment any way they can

That's how they rake in the big bucks.