FDA Seeks Comments on Its Program for Enhanced Review Transparency and Communication

On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications (BLAs) submitted under the Public Health Service Act.

The newly proposed program is part of the FDA’s performance commitments made under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA). The BsUFA, first passed into law in 2012, allows the FDA to collect user fees for the review of BLAs. If reauthorized, the act in its new form, BsUFA II, will allow the FDA to continue to collect such fees until 2022.

The FDA applies user fees to the review of applications through a variety of means, including the hiring of reviewers and support staff and the upgrade of its information technology resources. In its commitment letter, the FDA agrees to review performance goals associated with user fees, including the completion of applications and the taking of regulatory action within predictable timeframes. As part of its recommendations for BsUFA II, the FDA proposed a commitment to implement a review program for BLAs in order to minimize the number of review cycles needed for approval.

The new review program will facilitate additional communication between the agency and the applicant, and will further allow both parties to agree on a formal communication plan. The FDA says that an optimal review will allow for resolution of issues including labeling negotiation, risk evaluation and mitigation strategies, and post-marketing requirements and commitments that must be addressed before the agency can issue an approval.

The FDA seeks to evaluate the impact of the new program on the overall efficiency of application review; key objectives of the program’s assessment as described in the FDA’s statement of work include the following:

• Determining a baseline of data for applications received prior to the program’s implementation
• Analyzing data from all applications reviewed under the new program
• Determining the nature of the relationships among the program’s attributes, regulatory outcomes, and first-cycle review timing
• Determining the nature of the relationships among other aspects of the review process and the timing of first-cycle regulatory outcomes
• Collecting and analyzing applicant and FDA review staff feedback on applications

Comments on the Program for Enhanced Review Transparency and Communication for biosimilar products in BsUFA II will be accepted on Docket Number FDA-2017-N-3199 until July 31.

Meanwhile, the industry awaits congressional reauthorization of the BsUFA. Congress must reauthorize the BsUFA II prior to its summer recess if the act is to take effect in October as anticipated. A vote on reauthorization, which has bipartisan support, is expected in July.