EDITORIAL - Lost in Transmission — FDA Drug Information That Never Reaches Clinicians

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Lost in Transmission — FDA Drug Information That Never Reaches Clinicians

Posted by NEJM • October 21st, 2009 • Printer-friendly

M. Schwartz, M.D., and Woloshin, M.D.

The 2009 federal stimulus package included $1.1 billion to support

comparative-effectiveness research about medical treatments. No money

has been allocated — and relatively little would be needed — to

disseminate existing but practically inaccessible information about

the benefits and harms of prescription drugs. Much critical

information that the Food and Drug Administration (FDA) has at the

time of approval may fail to make its way into the drug label and

relevant journal articles.

The most direct way that the FDA communicates the prescribing

information that clinicians need is through the drug label. Labels,

the package inserts that come with medications, are reprinted in the

Physicians’ Desk Reference and excerpted in electronic references. To

ensure that labels do not exaggerate benefits or play down harms,

Congress might have required that the FDA or another disinterested

party write them. But it did not. Drug labels are written by drug

companies, then negotiated and approved by the FDA.

When companies apply for drug approval, they submit the results of

preclinical studies and usually at least two phase 3 studies —

randomized clinical trials in patients with a particular condition.

FDA reviewers with clinical, epidemiologic, statistical, and

pharmacologic expertise spend as long as a year evaluating the

evidence. FDA review documents (posted at

www.accessdata.fda.gov/scripts/cder/drugsatfda/) record the reasoning

behind approval decisions. Unfortunately, review documents are

lengthy, inconsistently organized, and weakly summarized. But they can

be fascinating, providing a sense of how reviewers struggled to decide

whether benefits exceed harms. Yet in many cases, information gets

lost between FDA review and the approved label.

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Read the full editorial here:

http://healthcarereform.nejm.org/?p=2126 & query=TOC

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