Hamburg Speaks on Effect of Sequester on User Fees

According to a report in CQ, speaking to a group of science writers yesterday, the FDA Commissioner, Dr. Margaret Hamburg "became the latest Administration official to say she's worried about the impact of a 9 percent across-the-board cut."CQ goes on to state that before "lawmakers can address the issue of the sequester, Congress first needs to pass a continuing resolution to fund the government until March"; and that the CR would have to "specify that  the FDA has authority to collect user fees from the  generic drug and biosimilar industries, because those programs did not exist until Congress created them earlier this year."Dr. Hamburg is quoted as follows:

It is very, very important to understand that if we really want products for use in the marketplace that there's a continuum of science that needs to be invested in and the regulatory science component by the FDA is critically important.

The full article in CQ is only available to subscribers to that publication.

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More on Sequestration and the FDA Budget for FY 13