FDA creates expanded access working group

Print 12 December 2014
BioCenture

FDA has created a working group to develop policies that would improve access to investigational therapies, Richard Moscicki, deputy director for science operations at the agency’s Center for Drug Evaluation and Research, told BioCentury.

The agency's Office of the Commissioner will lead the working group. “The number one priority has been to simplify the procedure and forms for the application of individual INDs,” Moscicki said.

Patient groups are driving the push for improving expanded access, he noted. “The patient community is clearly asking for more than what exists today in terms of accessibility of drugs that are still under investigational use, and we are trying to be responsive to patient needs and desires,” Moscicki said.

He added that substantial improvements in expanded access will require collaboration among a wide range of stakeholders. “We can look at things FDA can do to improve the situation, but the best solutions will come from a larger collaborative effort," he said.

FDA, the National Organization for Rare Disorders and Friends of Cancer Research are holding a public meeting on Feb. 4 to discuss options for collective action that would improve access to investigational drugs.

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