BioCentury
ARTICLE | Politics, Policy & Law

Sequester slowdown

How sequester, budget mess could delay FDA drug reviews; threaten biosimilars

March 11, 2013 7:00 AM UTC

Sequestration will cut a $209 million hole in FDA's FY13 budget, but a chaotic budget process caused by Congress's inability to pass a stable budget makes it impossible to know how much funding the agency actually will have for the rest of this year or next year. The combination of known cuts and budget uncertainty are likely to result in drug review delays, according to FDA Commissioner Margaret Hamburg.

Hamburg last week told BioCentury the agency cannot predict how many reviews will be delayed or the length of delays...