FDA Concerned About Surge in Biosimilar Workload

Thursday, February 4, 2016

Source: BioCentury

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told members of the U.S. House Energy and Commerce Committee's health subcommittee she is concerned about the agency's ability to manage what she expects will be an increasing number of biosimilars applications. "What I'm concerned about is that this program is going to explode," said Woodcock. "I'm concerned that we will not have the staff because we're always waiting to catch up."

Woodcock's comments came in response to a question from Rep. Frank Pallone (D-N.J.) about whether and how lack of funding is affecting FDA's ability to implement the Biologics Price Competition and Innovation Act (BPCIA). Pallone is the ranking Democrat on the E&C committee. 

The health subcommittee was holding a hearing on Thursday to discuss the implementation of BPCIA, which was enacted in 2010.

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