The surge of proposed rule relaxations by the Bush administration makes me wonder how bad "buyer beware" will get in George W.'s last year in office. The latest is a Food and Drug Administration proposal that lets drug and medical device makers promote their off label uses, i.e. non FDA approved indications. The New York Times reported:The rules would allow drug and device makers to provide doctors with copies of medical journal articles that discuss product uses that have not been vetted or approved by the F.D.A. The rules also say that drug companies do not have to promise to adequately test the unapproved use discussed in the article.
So essentially, your prescription drug's "expanded use" will be held to the same standard as an over the counter medication. Yee haw! Crank out the sales men and women, armed with journal articles. How many drug companies will start their own medical journals to broaden indications for their drugs?
This rule change follows a SEC relaxation of accounting standards for foreign firms. They merely need to publish their financial statements in English on their web sites. U.S. accounting standards? They mean nothing...
