June 7, 2018

FDA Announces Modernization of Drug Review Process and Operations

Holland & Knight Healthcare Blog
Michael J. Werner

On June 4, 2018, the U.S. Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19 review divisions. Its role is to review applications and make approval decisions as well as issue guidance and policy.

The reorganization effort is part of FDA’s broader effort to modernize its organization and processes to provide more efficient drug review. Other components of the broader plan include use of adaptive clinical trial designs and real-world evidence in the pre- and post-market setting.

CDER Director Janet Woodcock said in a June 4 blog post that the proposal would incorporate the following elements:

Enhancing The Focus on Multidisciplinary Teams

Woodcock noted that “assessing new drugs requires large and well-coordinated teams of highly trained professionals with many different types of expertise.” It also requires coordination across many offices within CDER. According to Woodcock, the proposed plan will lead to better staff integration including assigning a multi-disciplinary team to work on a new drug application early in the process.

Enhance Recruitment Efforts

Dr. Woodcock said these efforts will provide the staffing necessary to support development and approval of innovative new drugs.

Reorganizing The Office

According to Woodcock, FDA is proposing to increase to nine the number of offices that oversee review divisions and is envisioning 30 therapeutic-specific review divisions within those offices – up from our current 19. In addition to enabling greater efficiency, Woodcock said these changes will help FDA better understand the diseases intended to be treated by the drugs being evaluated for approval. Sounding a similar theme, in his own statement about the effort, FDA Commissioner Scott Gottlieb said the agency is considering publishing “hundreds of new clinical guidance documents,” many of which will be disease-specific.

Emphasizing The Importance of Safety Across a Drug’s Lifecycle

Woodcock explained that FDA will establish a “unified post-market safety surveillance framework to monitor the benefits and risks of drugs across their lifecycles, both before and after approval.”

Incorporating The Patient Voice

The plan includes incorporating the patient voice in patient-focused drug development. Details about this are still unknown.

According to Commissioner Gottlieb, FDA’s goal is to engage sponsors earlier in the development process to ensure that “trial designs are efficient and structured in the most effective way to identify risks and measure benefit.” He also said there will also be “more ability to engage external stakeholders, such as disease specialists, academic researchers and regulatory partners at other agencies.”

Gottlieb went on to say that the goal of the program is “to make sure that the drug review divisions are therapeutically focused to promote efficient review and provide greater scientific leadership to academic, industry and patient groups.” He said that these changes will provide drug reviews that are “more tightly integrated around a common review process, and a common review template that’s more easily collaborated around.”

Many of the details of the plan, as well as timeline for implementation, are unclear. The proposal is currently being reviewed by the Trump Administration and Congress to determine whether new legislation will be needed to implement these changes.

Related Insights