FDA "Might Allow Off-Label Promo"

The US Food and Drug Administration might be prepared to permit the off-label promotion of indications for the few products for which there is no financial incentive to conduct clinical trials for that indication, according to FDA Commissioner David Kessler, testifying before the House Subcommittee on Health is month (see also page 14).

One of the three proposed FDA reform bills pending in the House, Representative Burr's HR 3199, would permit the dissemination of journal articles on off-label uses. This provision, according to Dr Kessler, would discourage manufacturers from conducting trials to back their promotional claims. However, he told the subcommittee, by "working together," there might be a way of approaching the issue so that the getting of information can be balanced with ensuring that the companies conduct the new trials.

The problem with the way proposed legislation is written is that it provides "off-label promotion for everything," not just indications for which there is no financial incentive to conduct trials, said Dr Kessler. Final determination of a product's efficacy is needed, he told the meeting, and if the responsibility for conducting the trials is not to be placed on the company, "then we have an obligation to figure out how we're going to get those answers."