FDA Proposes Process Modernization to Support New Drug Development

The US Food and Drug Administration has proposed changes to modernize the new drug regulatory program through process changes and organizational restructuring. Overall, the FDA estimates the changes will improve efficiency by at least 20% and better target resources for product reviews.

“These changes are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities,” said Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research in a June 4, 2018 post on FDA Voice, the agency’s blog. “The proposals include regulatory and review process changes as well as organizational restructuring. We also intend to strengthen the support structures, including personnel and Information technology (IT), that underpin the regulatory process.”

Woodcock highlighted the key elements of the proposed plan. It calls for enhancing recruitment on a multidiscipline basis, including using hiring incentives and other provisions from the 21st Century Cures Act.

It also seeks to increase the use of multidisciplinary teams for assessing innovative new drugs. “A central component of our proposed changes involves stronger integration of our talented staff so they can better work together, within and across offices, a concept we refer to as ‘integrated assessment,’” said Woodcock in the blog. “Previously, CDER reviewers would seek consults from specialists in other scientific disciplines (as issues were identified in the course of review). For greater collaboration, a cross-disciplinary team will be assigned to work on a new drug application at the outset,” she said in the blog.

The proposal would also centralize project-management functions within CDER’s Office of New Drug Development. CDER currently has 19 separate review divisions that regulate drugs. “Over time, many divisions have developed procedures specific to their areas of review,” said Woodcock in her review. “We are proposing a single and consistent process: [o]ne organization with one process. Our aim is to enable our scientific and clinical experts to focus on what they know best–science and medicine–and our regulatory experts to manage the many processes we conduct.”

She also said that CDER is seeking to improve knowledge management by enhancing its IT capabilities and access to information. “We want to make it easy for staff to find and use scientific and regulatory data, information and precedents,” she said. “We’re also proposing changes that will increase the number of offices that oversee our review divisions from five to nine, and we’re envisioning 30 review divisions within those offices, up from our current 19. 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.”

She added that CDER 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, and will incorporate “the patient voice in modern patient-focused drug development.”

FDA Commissioner Scott Gottlieb further noted some of the benefits of these proposed changes. “One goal of this modernization of our process, for example, will be the ability to issue much more product-specific guidance documents,” Gottlieb said in a June 4, 2018 statement. “We’ll develop hundreds of new clinical guidance documents and make sure they stay up-to-date to reflect the latest science.”

Gottlieb also said that some of the new organizational structures would also allow the agency’s review staff to have more time for reviewing and providing feedback to sponsors on clinical protocol. “One 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 said in his June 4 statement. “Equally important, there will also be more ability to engage external stakeholders, such as disease specialists, academic researchers, and regulatory partners at other agencies. And with patient-focused drug development becoming a reality, ongoing relationships and interactions with patient groups are becoming an important part of our regulatory practices.”

Gottlieb said that part of these modernization efforts for increased organizational efficiency and possible structural changes “would ultimately flatten the overall matrix of our review process and explained the value in creating new therapeutic-specific divisions. “The goal 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. We believe this will deepen internal collaboration and enhance external scientific exchange.”

He further highlighted the benefit of improving the knowledge-management process. “We also want to make the entire review process and the development of the key review memos better organized, so that our medical staff can document their findings more efficiently and spend more of their time on advancing scientific work in their fields,” said Gottlieb.” According to our own assessment, we believe the new alignment and processes will improve efficiency by 20% at a minimum overall. This is, in part, the result of better workflow and workforce management and greater internal collaboration across the different review functions. The additional efficiency we achieve will be channeled toward the development of more product guidance and thought leadership. We’ll engage the external community more closely in our work, especially patients who inform our patient-focused drug development, with the aim of advancing more modern regulatory principles.”

Source: FDA Voice, FDA

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