CDER Moves Dispute Resolution Program as Generic Disputes Rise

Regulatory NewsRegulatory News | 08 June 2018 |  By 

In an email to staff on Thursday Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), announced that the center's formal dispute resolution program is moving in response to an increase in disputes from generic drugmakers.

Specifically, Woodcock said the program would move from its current home within the Immediate Office of the Office of New Drugs (OND) to the Office of Executive Programs (OEP), allowing the program to be managed at the Center level.

The reason for the move, Woodcock said, is that the program is used by both OND and the Office of Generic Drugs (ODG) and that the number of formal disputes raised by generic drugmakers is on the rise.

"In the last four years we have seen an increasing number of appeals within OGD as well. In fact, in 2017, the number of appeals reviewed in OGD exceed the number in OND for the first time," Woodcock said.

However, Woodcock said that while the program is moving, the process for formal dispute resolution will remain unchanged.

"The [formal dispute resolution project manager] will continue to establish and maintain policy for the program, triage all appeals submitted to CDER, report to Congress on FDR performance goals…and manage the review process for center-level appeals," she said.

Woodcock also announced that Melissa Sage, previously the deputy ombudsman at the Center for Devices and Radiological Health (CDRH), will serve as the formal dispute resolution project manager in addition to her new role as assistant CDER ombudsman.

The announcement comes just days after FDA proposed a more sweeping reorganization of CDER's new drugs review program that would sharply increase the number of offices and review divisions within OND.


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