Modernizing FDA's New Drugs Regulatory Program

Reorganization of the Office of New Drugs

In 2017, FDA’s Center for Drug Evaluation and Research (CDER) embarked on an initiative to modernize the New Drugs Regulatory Program. This effort will allow CDER to better serve patients and better support staff in their work to carry out the center’s mission – to protect and promote health by making sure that human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients. We are working to build on our past successes and strengths by implementing problem-focused, interdisciplinary, team-based approaches so we can meet the challenges of evolving science, new drug platforms, and new drug targets, while incorporating the patient voice in development.

The modernization of the New Drugs Regulatory Program will be a long-term process of continuous improvement involving multiple initiatives. We have begun implementation of some initiatives and will continue over the course of 2020. Additional information will be added as programs and projects progress.

The modernization focuses on six strategic objectives:

1. Scientific Leadership
   Grow our scientific expertise and clarify pathways to regulatory approval.

   Scientific leadership is vital for our ongoing success. Addressing unmet medical needs is an important part of our public health mission. As such, we aspire to expand our scientific expertise to enable better regulatory decisions. We will continue to hire talented scientists and work to develop long-term career paths for them, so they can become our next generation of seasoned leaders. We will proactively collaborate with academic medical scientists and patient/disease advocates, provide scientific vision and direction, and strategically foster drug development.

2. Integrated Assessment
   Critically, collaboratively, and consistently assess whether information in drug approval applications meets legal and regulatory requirements.

   We are implementing a new process with early identification which focuses on important application-specific issues, uses a team-based interdisciplinary model, and increasingly incorporates the patient perspective to provide an integrated assessment.   

3. Benefit-Risk Monitoring
   Systematically monitor the benefits and risks of approved drugs pre- and post- approval to effectively protect the American public.

   Ensuring safety of all drugs remains a key component of our mission and our new plans.  We will work to establish a unified post-market safety surveillance framework to monitor the benefits and risks of drugs across their life-cycles, both before and after approval. 

4. Managing Talent
   Attract, develop, and retain outstanding people.

   We will use various hiring mechanisms such as the 21st Century Cures Act pay authority to enhance efforts to retain our current staff and attract and recruit future staff for the New Drugs Regulatory Program, assuring the next generation of leaders.

5. Operational Excellence
   Standardize workflow, business processes, roles, and responsibilities to improve operational efficiency, and enable our scientists to focus on science.

    As part of the organizational structure changes within the Office of New Drugs (OND), we plan to standardize various regulatory and business processes. Our organizational structure will create a central office of regulatory, program and administrative operations servicing all of OND. Our aim is to enable our scientific and clinical experts to focus on what they know best – science and medicine – and allow our regulatory and administrative experts to manage the many processes we conduct.

6. Knowledge Management
   Facilitate the identification, capture, distribution and effective use of information.

   Knowledge management is essential to leverage the data we receive from outside sources as well as what we generate from within the FDA. Vast and diverse information is submitted to and generated by the New Drugs Regulatory Program. We plan to markedly expand knowledge management capabilities, which will allow us to better retrieve and utilize information that will improve decision-making and accountability.

Modernization of Programs and Projects

These programs and projects are currently underway.

Integrated Review for Drug Marketing Applications
Directly supports the following strategic objectives: Scientific Leadership, Integrated Assessment, Operational Excellence, Knowledge Management, and Benefit-Risk Monitoring.

We are implementing a new integrated review process and documentation template to support reviewers in conducting a scientifically-rigorous review that efficiently documents regulatory decisions.

The guiding principles of this initiative are issue-focused assessments, enhanced communication both within the review team and with the applicant, and stronger interdisciplinary collaboration.  We believe that the format and content of the new integrated review will provide a clearer description of our analysis of the scientific issues raised by the application and will more effectively communicate the basis for the regulatory decision.

The integrated review process includes the following enhancements:

• A review issue tracking tool to be utilized from investigational new drug (IND) development to approval and post-approval
• New roles to support the review team and allow reviewers to focus on the science and regulatory aspects of the application- clinical data scientists will support clinical safety data verification and analyses, and medical editors will provide editing and formatting services
• Purposeful interdisciplinary working meetings with early leadership involvement to focus on an integrated assessment of specific review issues

To illustrate the new integrated review template, which has three main components– an executive summary, an interdisciplinary assessment, and appendices – we rewrote the original review for Pifeltro (doravirine) and Delstrigo (doravirine, lamivudine, and tenofovir disoproxil fumarate) to provide an example. The drug approval package, including the original review, is available on Drugs@FDA. On June 26, 2019, we published a federal register notice seeking feedback on this new approach. The review for Dovato (dolutegravir, lamivudine), the first prospective review to use the new process and template, is also available for illustration.

IND Review Management
Directly supports the following strategic objectives: Integrated Assessment, Knowledge Management, and Operational Excellence.

INDs are applications to the FDA to permit testing of investigational new drugs in humans.   We are implementing initiatives to streamline our scientific review and processes for INDs throughout their life cycle, while maintaining our high standards. The first initiatives focus on the 30-day review of the initial IND application and on review of select clinical protocols with new processes and issue-based templates. The new processes and templates include enhancements to:

• Promote consistency across divisions and increase effectiveness of documentation practices
• Foster collaboration and enable better knowledge management
• Establish procedures that standardize the review process, clearly define roles and responsibilities, and improve our ability to provide high-quality feedback to sponsors in a timely manner
• Develop a risk-based approach to categorize incoming information from sponsors and identify protocols that should follow a more expeditious review process

Advisory Committees
Directly supports the following strategic objectives: Scientific Leadership, Integrated Assessment, Operational Excellence, and Knowledge Management

In 2019, CDER established an Advisory Committee workstream for its New Drugs Regulatory Program to promote efficient and excellent advisory committee meetings that provide well-informed, clear, and consistent expert advice. The Advisory Committee workstream started by focusing on three areas of advisory committee meeting planning where clear and streamlined policies, processes and resources would be helpful for FDA staff. These include clarifying when an advisory committee meeting is appropriate, finding ways to streamline the procedure for recruiting and retaining experts on committees, and developing accessible resources for FDA review teams to improve the development of high-quality FDA meeting materials and day-of execution.

Postmarket Safety Management
Directly supports the following strategic objectives: Scientific Leadership, Integrated Assessment, Knowledge Management, and Benefit-Risk Monitoring.

New postmarket safety management processes are being designed to create a more standardized and consistent approach to managing drug safety throughout the life cycle of a drug.  This postmarket drug safety framework will foster:

• Cross-disciplinary, collaborative, science-focused assessments that optimize utilization of safety expertise
• Clear roles, responsibilities, and governance that supports rapid decision making
• Standardized and more efficient approaches to evaluating safety signals

Assessing and Developing Talent
Directly supports the following strategic objective: Managing Talent.

FDA is enhancing its efforts to assess and manage talent for the New Drugs Regulatory Program with the development of an effective and consistent process for interviewing, onboarding, training and evaluating new staff using a new role competency framework.

Administrative Operations
Directly supports the following strategic objective: Operational Excellence.

Efforts are underway to optimize administrative structure and functionality to:

• enhance customer focus as well as streamline processes and communication with internal and external stakeholders
• specialize administrative staff in one or more functional areas to promote employee engagement
• enhance FDA’s time reporting functionalities to develop resource planning capabilities

Transition Management & Reorganization of the New Drugs Regulatory Program
Directly supports the following strategic objectives: Scientific Leadership and Operational Excellence.

The New Drugs Regulatory Program includes modernized processes and documentation and a restructuring of the clinical offices and divisions within OND (and corresponding changes in the Office of Translational Sciences and the Office of Pharmaceutical Quality). The new restructuring of OND, approved in September 2019, creates offices that align interrelated disease areas and divisions with clearer and more focused areas of expertise. The changes increase the number of offices that oversee our review divisions from six to eight, and increases the number of clinical divisions from our current 19 divisions to 27 plus six non-clinical review divisions. In addition to enabling greater efficiency, these envisioned changes will help us to better understand the diseases intended to be treated by the drugs we evaluate for approval—another way we aim to enhance our knowledge management and scientific leadership.

Additional information on the goals of Modernization:

• New Drugs Modernization Program Reorganization
• Dr. Woodcock FDA Voices blog – FDA Proposes Process Modernization to Support New Drug Development
• Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office
• Dr. Woodcock video - State of CDER 2019 (:41-2:30)
• Dr. Woodcock's presentation at FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law