FDA rules on off-label article distribution issued

The FDA may soon be loosening its guidelines for distribution of journal articles discussing unapproved uses of approved drugs and devices, a move which some consumer advocates (and some legislators) say would all but open the floodgates to off-label marketing. The rules, which are in their comment period, will soon become final.

Under the previous rules, which actually expired in 2006, the FDA had some fairly tough standards in place. If pharmas and device-makers wanted to distribute journal articles promoting off-label uses of their products, they had to submit the articles to the FDA in advance for approval. What's more, they had to file a supplemental new drug application for the use they wanted to promote within three years of doing so. The new draft guidelines don't impose these limits, though they recommend against distributing articles funded by one of the manufacturers of the products discussed. All told, it sounds like the new FDA rules are a big step away from where they were in the past. With hard-and-fast rules being softened into "recommendations," it's hard to imagine that pharmas or device-makers will bother to follow them. After all, there's a ton of money to be made on off-label use of these products, which are, after all, more common than approved uses. The question is, is it more likely that someone will be hurt by an inadequately researched off-label prescription under the new system?

To learn more about this issue:
- read this Modern Healthcare piece (reg. req.)
- read this FiercePharma piece

Related Articles:
Too much off-label regulation? Report
Rep decries off-label marketing "loophole." Report
Did pharma ask the FDA for off-label rule change? Report
New warning for off-label Fentora. Report

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