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BIO Submits Comments on FDA : New Drug Regulatory Program Modernization: Improving Approval Package Documentation and Communication

August 26, 2019

August 25, 2019

Re: Docket No. FDA–2019-N-2012: New Drug Regulatory Program Modernization: Improving Approval Package Documentation and Communication.

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the New Drug Regulatory Modernization: Improving Approval Package Documentation and Communication.

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 FDA’s goal of providing greater clarity on FDA's application review and decision-making process. We commend FDA’s efforts to modernize the New Drug Regulatory Program through the use of: (1) The Clinical Data Summary Pilot Program (Pilot), through which parts of a Sponsor’s clinical study reports (CSRs) are posted and (2) a new integrated template that will be used to document FDA's review of new drug applications and efficacy supplements. BIO commends the Agency’s efforts to improve transparency in the drug approval process and believes increased transparency will ultimately benefit patients, BIO member companies themselves make strong efforts to support clinical trial transparency by posting protocols and results and sharing data consistent with the Final Rule on Clinical Trial Registration and Results Information Submission. BIO strongly supports the new integrated review process and template and agrees that this format will also clarify and improve communication between FDA and the Sponsor, as well as provide new insights regarding FDA’s regulatory decision making.

The FDA has stated it is considering where to focus its efforts to increase transparency around the drug approval process: either on the development of new integrated review documents, or on the release of CSRs (as seen in the Clinical Data Summary pilot). For the following reasons, we believe that the greatest benefit would be achieved by focusing on the new integrated review template:

  1. The release of CSRs, while commendable, would not give stakeholders any additional significant insights to the comprehensive Agency’s assessment of benefit-risk.
  2. The clinical protocol and statistical analysis plan, which were also in-scope for release under this initiative, are already made public by Sponsors on, following study completion.[1] 
  3. Additionally, given that other countries are engaging in their own transparency initiatives involving publication of clinical data, a subset of CSRs would still be available even if the FDA did not routinely publish them.
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