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Midnight Drugs
Much has been written about the plethora of midnight regulations promulgated by the Bush Administration. Less appreciated is the impact of midnight guidance documents.

In mid-January, the FDA released a guidance document providing recommendations for medical products manufacturers to follow when reprinting and disseminating journal articles. According to one news article, the guidance makes "it easier for drug manufacturers to promote 'off-label' prescription drug uses, which can be deadly for patients."

Despite the article's needless, fear-mongering hyperbole, it does discuss the important underlying policy issue; appropriate methods for pharmaceutical companies to follow when educating physicians about potentially beneficial off-label therapeutic treatments. Readers should not mistakenly assume that off-label uses for pharmaceuticals are inherently inappropriate.

The FDA released the guidance in draft form for public comment in February 2008. The document was, and remains, controversial. A senior member of the House leadership described the final guidance as "a 'long-coveted parting gift' for the pharmaceutical industry that 'fundamentally undermines' the FDA's authority." A Republican Senator remarked that "A legislative fix may be in order."

There are two lessons to be drawn from the guidance document controversy, one for the Obama Administration and the other for Congress. The new Administration should re-evaluate the importance of OMB review of significant agency guidance documents prior to their issuance. Congress, meanwhile, should recognize the "midnight" actions by the previous Administration are too extensive to for legislative action to be practical on a case-by-case basis. Instead, Congress needs to grant OMB broad authority to review and, if warranted, correct outgoing actions by the prior Administration.

See news story

See FDA guidance document

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