FDA user fee bill hits late snag

Negotiations on a final version of a bill to create a system of "user fees" to speed up FDA review times for medical devices are reportedly moving along, but Tuesday the talks hit an unexpected snag.

The House passed a bill Oct. 9, but Senate Health, Education, Labor and Pensions Chairman Kennedy said he had lingering concerns about provisions allowing "third parties" to inspect device manufacturing facilities and about regulation of single-use devices "reprocessed" for additional uses.

Now, some Senate Republicans reportedly are concerned about the user fee section of the bill. Under the House-passed measure, small device makers could have fees reduced or waived in some circumstances, in response to complaints from some firms that the user fees could impose an undue hardship on smaller companies. But senators have decided they want to revisit the question of what qualifies as a small firm.

Those involved in the negotiations say they still hope a final bill can be worked out before the end of the week.

"It will happen at the 11th hour," predicted a lobbyist who has been watching the talks. "It's just not the 11th hour yet."