Saturday, January 17, 2009

Off Label Use of Pharmaceuticals Gets Speedy Nod from FDA

I'm concerned, and I hope that a lot of others are concerned as well. It seems that U.S. health officials are now publishing guidelines that make it easier for pharmaceutical companies to tell doctors about unapproved uses of medicines. This seems to be a risky and wild ride now that it is endorsed by the FDA.

The action could help companies expand the markets for medicines and medical devices by distributing copies of medical journal articles that describe unapproved uses of their products.

The move puts in place a policy that drew objections from congress (and drug-industry critics) when it was proposed last year. It appears to allow promotion of pharma products without adequate testing -- something that not even dietary supplement companies are allowed to get away with.

Rep. Henry Waxman, democratic chairman of the House of Representatives Energy and Commerce Committee, called this FDA decision "a long-coveted parting gift," with a fair amount of sarcasm directed at the outgoing Bush administration.

Doctors have long been able to prescribe drugs for any use they see fit, a practice known as "off-label" use. In the past, the law was tough, and pharma marketers could not promote what doctors are using their drugs for in the off-label world. As an example, one doctor may prescribe an antidepressant to treat insomnia, but the pharma company has not been allowed to publish or distribute information pertaining to the drug's use for insomnia -- that is, until now.

In the world of dietary supplements, companies can not post information about traditional uses of their products, or discuss how doctors use them against disease. Supplement manufacturers have very rigid rules about this (and probably for a darn good reason, since the industry does such a terrible job of self-policing its marketing companies). If a number of doctors see success using an herbal formula for cancer, there's no way that the public or other doctors could find out about it, because the manufacturer would be prohibited (with the risk of huge fines) from sending that information on to other doctors or publishing it on their website.

It seems that the pharmaceutical industry has indeed been given a gift in this new ruling -- a type of marketing that even a dietary supplement manufacturer does not have access to.


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