FDA should allow for greater off-label use of medications, expert argues

In an op-ed in the Wall Street Journal (5/2, A11), Richard Epstein, professor at the University of Chicago and a senior fellow at Stanford University's Hoover Institution, noted, "As President Barack Obama's new Food and Drug Administration team of Margaret Hamburg and Joshua Sharfstein take the reins, they must decide what to do with off-label uses of FDA-approved drugs." Epstein asserted that "the FDA and Congress should protect physicians' and patients' right to off-label uses -- and for the first time allow drugmakers to promote off-label uses that prove beneficial." He argued that, "once a drug passes Phase I clinical trials -- which test for high toxicity -- why not make it available for general distribution through the [National Comprehensive Cancer Network (NCCN)], which has far superior access to specialized medical expertise than the FDA?" While the idea "may sound radical...when lives are at stake, we should consider drastic measures."