The FDA has finally released proposed rules that would allow pharma to distribute journal articles that support off-label uses of their products--two months after an irate Congressman pulled the veil off the same proposal. Then, as now, the rules are controversial. They'd not only let drug and device makers distribute journal articles, but even specify that drug makers wouldn't have to promise to test the uses the articles discuss.
Advocates say the FDA is so slow to look at new drug and device uses that companies have to intervene; otherwise docs wouldn't know about life-saving new techniques for months or years. "The consequence of rapid disclosure...could be measured in lives," former FDA deputy Scott Gottlieb told the New York Times.
Critics, however, say drug and device companies have a history of promoting off-label uses that later proved dangerous. Also, they say, allowing companies to talk about unapproved uses takes away any incentive for additional research to prove that the new uses are actually beneficial.
What do you think? An informal Wall Street Journal Health Blog poll found that 42 percent of readers found the new rules too lax, 23 percent too strict, and 35 percent about right.
Too much off-label regulation? Report
Rep decries off-label marketing "loophole." Report