Congress Actually Passing Legislation?
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.