Biotech Values

[DewDiligence]

Did anyone attend FDA Generic Drug User Fee meeting? I've seen little comment about what is an important topic.

This issue has been bouncing around for what seems like half a lifetime. Here’s an excerpt of a Washington Post article from almost five years ago (#msg-9563839):

Some at the agency and in the industry say the answer is to have generic-drug makers do what brand-name makers did in the early 1990s—pay "user fees" to finance new hires by the FDA. Today, user fees support about half the FDA staff that reviews new drug applications.

But the generic drug industry…leaders say they cannot reach consensus on whether to accept user fees.

Others argue that since the low cost of generics has broad benefits for the public, Congress should be willing to pay for added staffing.