What Does a “Modernized” FDA Mean for Drug Industry?
​​​[Posted on: Thursday, June 7, 2018]

FDA leadership believes it can do better at reviewing new drugs by reorganizing its review divisions’ personnel and moving to centralized project management. This week FDA announced details about the planned modernization of the Office of New Drugs (OND) at the Center for Drugs (CDER). Four of the six steps proposed to modernize are incremental changes to what FDA has been already doing for a few years. These include hiring more reviewers, creating multi-disciplinary teams for review of applications, surveillance for safety issues of approved drugs, and including patient opinion in regulatory decisions. A major new proposal is to centralize project management activities across the entire OND. There are 19 Divisions or departments within OND that review products intended for different diseases. Currently each Division has project managers who coordinate tasks within the respective Division. Over time, the Divisions have developed procedures specific to their areas of review and logistical preferences. Hence the industry sees variability in processes across different Divisions. For example, one Division may ask for information quite different from another Division for similar activities, say granting a request for meeting. Under the new proposal, project management will be taken out of the Divisions to create a centralized project management department that would oversee applications being reviewed by all Divisions within the OND leading to harmonization of project management practices for all applications. This should free up the resources at the Divisions, so they can focus on the reviews rather than on administrative processes. The second major proposal is to expand the current 19 Divisions to 30 Divisions to increase specialization within a given Division. FDA also plans to organize its knowledge base collected over the years for the numerous products it reviews to assure consistent regulatory decision-making based on “scientific and regulatory data, information and precedents”. There are a few things to be noted for these modernization efforts. First, these are internal process changes and not policy changes so the effects obvious to outside may be minimal at best or none. FDA already is 100% on time per the PDUFA timelines so an improvement would be doing better than the PDUFA timelines. It could mean that FDA could handle more expedited approvals. Second, these changes are only proposed for CDER, not for CBER or CDRH, meaning that processes for biologics and medical devices are not affected. Even within CDER, these efforts focused on new drugs and not generic drugs. Third, the implementation should be rapid. Although no defined timelines for implementation have been announced, since most of these are incremental changes to existing trends at the Agency, it should not take much for OND to implement these changes. FDA believes that these changes would have several long-term benefits in terms of the improvement of the review process and interaction of its reviewers with the industry and public.