Biosimilars program at risk, Hamburg says

Congress must act by March 27 to keep FDA's biosimilars pathway alive, FDA Commissioner Margaret Hamburg told BioCentury on Thursday. Congressional action is also needed to launch a planned expansion of FDA's generic drug review program and to allow FDA to spend increased prescription drug and medical device user fees, she said.

The biosimilar pathway and other FDA programs that rely on user fees are at risk as a result of the language Congress used last year in a continuing resolution that is funding the federal government through March 27. The CR extended FY12 budget levels and did not give federal agencies authority to increase spending -- even if increases came from industry user fees rather than from taxes. ...