Industry Seek Clearer Process, Lower Costs in GDUFA Comments

Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date.

The agency fielded 22 comments that, while generally supportive of GDUFA, pushed the FDA to implement three major changes to the next version of the law:

• Setting review goals that better reflect stakeholder expectations;
• Provide guidance on when and how to correspond with the agency during the submission process; and
• Basing fees on business size to create a more level playing field.

“The motto for GDUFA implementation should be, ‘no application (ANDA) left behind,’” said the Generic Pharmaceutical Association in their comments. GPhA emphasized the need for clarity, guidance, and predictability for industry, in order to more closely mirror PDUFA’s process.