Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research recently proposed changes to CDER’s new drug regulatory program. The proposals (here) include regulatory and review process changes, as well as organizational restructuring. The drive behind these changes are to free up resources so that the reviewers have more time to focus on drug development. These include unmet medical needs, collaborations needed for proper evaluation and reaching out to external scientists, expert physicians and patient communities.
FDA’s proposal includes recruiting the best and brightest individuals from many disciplines, enhancing focus on multidisciplinary teams, prioritizing operational excellence, improving knowledge management, emphasizing the importance of safety across a drug’s lifecycle and incorporating the patient voice. CDER acknowledges that, to be a successful drug regulator, FDA reaches well beyond its borders through collaborations with a wide variety of medical and scientific organizations such as those in biomedical research, the pharmaceutical industry, academia, global organizations and other regulatory agencies.
Dr. Woodcock says that these collaborations also extend to patients and their caregivers and advocacy groups.
The proposed changes involve stronger “integrated assessment” so the reviewers can work together within and across offices. A cross-disciplinary team will be assigned to work on a new drug application from the beginning. CDER currently has 19 separate review divisions that regulate and review drug applications. Over time, many divisions have developed procedures specific to their areas of review. For example, CDER uses its Managed Review Process (here), which was developed to provide a common management approach to the review of drugs, biological products, and devices under different regulatory pathways using a consistent set of management procedures. CDER, on the other hand, uses its 21st Century Review Process (here), which employs cross-disciplinary teams and procedures to coordinate and address scientific and regulatory issues within the standard review timelines. In addition to streamline these processes, the proposal would also bring the project management functions within OND with the hope of streamlining the process.
In a statement (here) released at the same time on the proposed modernization of FDA’s drug review office, FDA Commissioner Dr. Scott Gottlieb stated that “one principal aim of these proposed changes is to elevate the role of our scientists and medical officers to take on even more thought leadership in their fields. We want to give our 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.” With modernization of the process, FDA will have the ability to issue more product-specific guidance documents which includes hundreds of new clinical guidance documents.
One of the operational goals is to make the entire review process and the development of the key review memos better organized, so that the reviewers can document their findings more efficiently. FDA believes the new alignment and processes will improve efficiency by 20 percent. Those of us who must dig through the review summaries daily can only appreciate streamlined review memos.
In line with FDA’s recent initiatives, Dr. Woodcock plans to engage the external community more closely in their work, especially patients, with the aim of advancing more modern regulatory principles. In May 2017, FDA published the outcome (here) of a current-state analysis of its patient engagement activities, which revealed that taking steps like clarifying responsibilities and fostering systems and tools that promote transparency, accessibility, and collaboration within the Agency and with the public would help strengthen patient engagement efforts. This resulted in a proposed future state for FDA patient engagement activities with the objectives of developing a nuanced understanding of the patient perspective of disease and support patients and their advocates in understanding regulatory processes and in navigating FDA.
Although Dr. Woodcock does not get into the specific details of how CDER plans to integrate her proposals with FDA’s other objectives announced earlier, we welcome the initiative and look forward to more clarity on some of these ambitious goals as FDA is pushing and going beyond the borders.
