FDA User Fees Gain Momentum

How Have User Fees Affected the FDA?

Some policy experts answer that question by arguing that budget constraints contributed to regulatory delays in the past. The reform simply relaxed those constraints by increasing the resources for new-drug review. However, there is little empirical evidence to suggest that changes in the fda’s budget influenced regulatory delays and the speed of review prior to user fees. Other policy experts ...

No user fees, but perhaps user fees.

Congress is likely to approve generic drug user fees: action should spur faster FDA approvals.

$824 billion in the last decade. The cost savings benefit is obvious, and some even claim that generic products can be safer than their brand-name counterparts. Edith A. Rosato, RPh, Chief Executive Officer at the Academy of Managed Care Pharmacy, explains: “Generic drugs, by definition, are versions of brand-name drugs that have been available in the marketplace for many years. The longer a dr...

A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.

I propose to raise funds for postapproval studies of long-term drug safety by augmenting the existing "user-fee" system. Fees would be raised by an amount deemed optimal for revenue collection, and the U.S. Food and Drug Administration (FDA) would direct the incremental funds to a combination of randomized controlled trials, epidemiological studies, and postmarketing surveillance. User-fee augm...

User fees and beyond--the FDA Safety and Innovation Act of 2012.

n engl j med 367;14 nejm.org october 4, 2012 1277 legislators, and patient advocates. The driving force behind the legislation was the need to reauthorize statutorily defined user fees that pharmaceutical manufacturers (since 1992) and medical-device manufacturers (since 2002) have paid when they submitted applications to the FDA for the evaluation of new products. The bill sailed through a clo...