Posted by | June 23, 2012 07:18 | Filed under: Top Stories

by Stuart Shapiro

It’s kind of pathetic that it is news when Congess actually negotiates, and reaches, a bipartisan compromise on a bill, but news it is.  It’s not the biggest issue in the world but the House passed a bill reauthorizing user fees for FDA for the next five years and the Senate is likely to follow.

The legislation would raise — by more than $2 billion from the previous five-year period — the fees industries pay the FDA for safety and efficacy reviews. Drugmakers in September and device companies in February agreed to the increases in exchange for more meetings with the FDA throughout the review process that may produce faster product approvals.

Brand-name drugmakers have paid the fees since 1992, and device makers began their system in 2002. The bill adds user fees for generic versions of complex biologic drugs, a process not allowed until passage of the 2010 health-care law.

Maybe this is the start of a new era?  I wouldn’t bet on it.

By: Stuart Shapiro

Stuart is a professor and the Director of the Public Policy
program at the Bloustein School of Planning and Public Policy at Rutgers
University. He teaches economics and cost-benefit analysis and studies
regulation in the United States at both the federal and state levels.
Prior to coming to Rutgers, Stuart worked for five years at the Office
of Management and Budget in Washington under Presidents Clinton and
George W. Bush.