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Jill Wechsler is Pharm Exec's Washington Corespondent
Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.
In a recent staff memo, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), outlined several key initiatives and goals for the coming months, many affecting multiple CDER offices and addressing key challenges for the agency. At the top of the list is the need to track adverse events more effectively, especially those that did not appear during product development, as may be the case with new therapies that are tested and approved under accelerated programs. Postmarket assessment is important for identifying drug safety issues, such as the presence of genotoxic impurities, or nitrosamines, that have been identified in several types of drugs. Advances in tracking drug safety issues can help address continued drug shortages that too often limit patient access to medications and arise from manufacturing and supply failures involving multiple stakeholders.
CDER also will continue to address the opioid crisis through multiple strategies. These include decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder and expanding access to naloxone; fostering the development of novel pain treatment therapies; improving enforcement of diverted opioids and illegal drugs; and accessing the benefit/risk framework that evaluates not only the outcomes of opioids when used a prescribed, but also the public health effects of inappropriate use of these drugs.
A more internal goal is to fully implement CDER’s more streamlined, interdisciplinary new drug review process. This goal will further establish a more integrated review of new drug applications (NDAs) and biologics license applications (BLAs), as well as modernize approaches for managing investigational new drug (IND) applications and post-market drug safety. Despite some minor delays in standing up revised Offices of Nonprescription Drugs and of Specialty Medicine, Woodcock expects to have in place shortly a new organizational structure for CDER’s Office of New Drugs, along with changes in the Office of Translational Sciences, the Office of Surveillance and Epidemiology, and the Office of Pharmaceutical Quality.
More specific initiatives on the list involve finalizing a new regulatory approach to non-prescription sunscreen use and to further engage drug compounders to protect the public from contaminated products. A new Compounding Quality Center of Excellence aims to enhance collaboration among and provide educational programs for outsourcing facilities to improve the overall quality of compounded medicines.
Looking to the future, CDER officials will begin the next round of user fee negotiations to set the stage for reauthorization of CDER’s three user fee programs in 2022. These involve drugs, generic drugs and biosimilars, and are critical to CDER being able to “fulfill our mission of protecting the public health and accelerating innovation in industry,” Woodcock stated. In conclusion, she noted the importance of working to further improve internal processes for CDER’s governance structure, information technology, and hiring-a process that involves a more streamlined interview and selection process.