US lets drugmakers advise doctors on unapproved uses

[sabra]

Source: Reuters

WASHINGTON, Jan 12 (Reuters) - 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 <PFE.N> and Merck & Co <MRK.N> 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.

Read more: http://www.alertnet.org/thenews/newsdesk/N12332702.htm

[Donnachaidh]

1. Hope those doctors have their malpractice inusrance paid up to date. n/t

[mrs_p]

3. exactly my thoughts

they won't do it if they think at all they will be sued for it...

[MannyGoldstein]

5. They Already Do It All The Time

Contrary to popular belief, Docs are difficult to sue successfully.

[OhioChick]

8. You're absolutely right. n/t

[MannyGoldstein]

2. This Is A Very, Very Bad Idea

Stunningly stupid. It will be infinitely abused.

I work in this industry: the impact will be enormous.

[sabra]

4. we need to watch everything that BushCo is trying to get in before they exit...

[uppityperson]

6. Excuse my language, but to hell with that.

[benld74]

7. Where da ya think RLS came from?

[Igel]

9. Good, if the doctors are careful.

Lots of drugs are good for problems, but since there's no money in it they aren't tested and approved for it. Doesn't mean they don't work; it means that the doc has to be careful in using them.

To find out about them takes a lot of work and doctors don't have the time and, in some cases, just don't or can't care. Most of the drugs are generic at this point; some non-generics may be in testing for an ailment, but not yet approved; some may even have failed testing because they're dangerous for some populations but not others, and be useful in the case of certain patients.

I've had relatives take unapproved drugs, sometimes with great success, and in one case with far fewer side effects than the "approved" drugs that replaced the unapproved one when the FDA told the pharmacy to stop filling his prescriptions.

[damntexdem]

10. It's one thing for docs to experiment with unapproved uses, although they need to be careful.

It's quite another for drug-company shills to 'advise' docs on such uses. And if a bad outcome results from 'off-label' use, not just the deep pockets of the doc's malpractice insuror should be affected, so should those deep, deep pockets of any drug company whose shills advised that use.

[hootinholler]

11. Isn't an unapproved use what led to the Phen-Phen tragedies?

I can see nothing good to come of this.

-Hoot