On June 4, the Food and Drug Administration (FDA) released additional information regarding the proposal to modernize the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs. The FDA proposes to modernize the drug approval process by improving the efficiency rate by at least 20 percent. The planned modernization of the drug development process would give FDA scientists more time, tools, and support to evaluate the safety and efficacy of new drugs, thus improving clinical guidance and regulatory principles.
Reorganization
“To advance these public health goals, the director of our Center for Drug Evaluation and Research (CDER), Dr. Janet Woodcock, has proposed to her center an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs,” said FDA Commissioner Scott Gottlieb, MD.
Because of the reorganization, the FDA’s Office of New Drugs will grow from five to nine offices, with as many as 30 divisions in each those offices. Additionally, the long-term career paths of scientists within the FDA with be extended as dictated by the 21st Century Cures Act.
The key components of the proposed reorganization include:
- Recruiting the best and brightest individuals from many disciplines
- Enhancing the FDA’s focus on multidisciplinary teams
- Prioritizing operational excellence
- Improving knowledge management
- Emphasizing the importance of safety across a drug’s lifecycle
- Incorporating the patient voice
One of the major goals of the proposal is to improve scientific and medical leadership. The proposal will elevate the role of FDA scientists and medical officers to take on more thought leadership in their fields. This is intended to give the clinicians and scientists more time, better tools and greater support to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.
Additionally, FDA review staff will have more time to review and provide feedback to sponsors on clinical protocols by engaging 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. They also anticipate it will enhance their ability to engage external stakeholders.
The proposal will also reform drug review divisions, which will be more therapeutically focused to promote efficient review and provide greater scientific leadership to academic, industry and patient groups. This is intended to enhance collaboration with external stakeholders.
Furthermore, the proposal will make the scientific disciplines that conduct review more tightly integrated around a common review process, and advance a common review template that’s more easily collaborated around. It will ensure the entire review process is more integrated across discrete areas of science and regulatory expertise, and make the entire review process and the development of the key review memos better organized.