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BIO Comments on FDA Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications

December 18, 2019

Re: Docket No. FDA-2018-D-3103: Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff.

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the FDA’s Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO appreciates the Agency’s efforts to update and release the Draft Guidance on Good Review Management Practices and Principles. BIO views this guidance as an important component for informing both Industry Sponsors and FDA staff and reviewers about the Agency’s thinking around regulatory review practices and support for a more efficient and transparent review of new therapies. To both strengthen the document and ensure that all stakeholders have appropriate information and resources related to good review practices, BIO requests that the FDA cross reference other tools for Sponsors and reviewers in the finalized guidance. While we appreciate FDA’s efforts to streamline the guidance, the current Draft Guidance removes a significant amount of information included in other FDA guidance documents including Manuals of Policies and Procedures (MAPPS), the FDA 21st Century Review Process Desk Reference Guide (DRG),[1] and the FDA guidance on Formal Meeting Between the FDA and Sponsors and Applicants or PDUFA Products[2] among others, however the Agency does not link to those resources in the Draft Guidance. Additionally, we also request that the FDA update the DRG (last updated in September 2014), CDER’s Good Review Practices guidance, and CBER’s review process to include information that was removed from the Good Review Management Practices and Principles guidance. Additionally, we note GRMPs are relevant for both original applications as well as efficacy supplements as noted in the Draft Guidance. The DRG should also be updated to add more specificity on the communication and review practices for efficacy supplements.

BIO also believes that review practices and principles should also allow for discussion of a potential Risk Evaluation and Mitigation Strategies (REMS), post-marketing requirements and post-marketing commitments, and labeling as early as possible in the review cycle to ensure the that these deliverables are well thought-out and feasible. To this end, BIO request that the FDA reference early discussions with Sponsors about these aspects as good review practices and principles in the Draft Guidance.

BIO would also like to emphasize the importance of both informal (non-binding) and formal (binding) meetings between Sponsors and the Agency as important mechanisms for Industry Sponsors to interact with the Agency and receive timely feedback during the review. To support communication and transparency, we encourage the Agency to continue to support development of communication plans and be open to providing such communications/advice for both original applications and efficacy supplements.

Finally, the PDUFA VI commitment letter contains a commitment that FDA will outline “in the appropriate internal documents… the Agency’s process for resolving internally any scientific or regulatory issues that arise, as well as a commitment for the medical product centers and OCP to coordinate and complete reviews and related activities when consults in timelines set forth by PDUFA and other published documents (e.g., the GRMP guidance and GRMP MAPP)”.  While the revised Draft GRMP Guidance contains an operating principle related to the importance of team collaboration, BIO suggests that the FDA more strongly add language in the Draft Guidance that reflects the PDUFA VI commitment that all medical product centers complete reviews and related activities (including resolving any scientific or regulatory issues) within a timeframe that allows for PDUFA goal dates to be met.

BIO appreciates this opportunity to submit comments regarding Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff.  We would be pleased to provide further input or clarification of our comments, as needed.