FDA user-fee legislation may be in the home stretch, but some proposals could slow it down as it nears the finish line. As Politico reports, amendments tagged onto user-fee bills promise to drag out the debate, as Republicans advance some industry-friendly changes that others don't support.
For instance, House Republicans want to change the FDA's mission statement to include economic considerations, rather than just safety and efficacy, when approving new products. The FDA hates the idea, and officials have said in hearings that gauging the economic effect of a drug approval could end up slowing the whole process. More to the point: The Senate's not wild about it, either.
"Then there's the question, for instance, of what you do about a new beneficial product that costs jobs in the competition," Pew Health Group's Alan Coukell told Politico. "This is not FDA's job."
And then there are the provisions to incentivize antibiotic development. The Senate bill would limit those incentives to drugs that treat "serious or life-threatening conditions," but the House Republicans want them to apply to most antibiotics.
Politico says the House bill is expected to include "more industry-friendly provisions, especially for medical devicemakers." As Regulatory Focus reports, some House members have been pushing for tighter regulatory standards for device approval, other reps are pushing hard for looser ones.
- see the Politico piece
- get more from Regulatory Focus