FDA’s Drug Shortage Staff (DSS) resides in the Center for Drug Evaluation & Research (CDER). It consists of a dedicated staff of 11 scientific and regulatory experts who are responsible for the coordination of all activities related to the prevention and mitigation of drug shortages. As the number of reports of drug shortages has increased, this staff has grown from 3 professionals to 11 in the past few years.
The DSS coordinates with a host of other experts in CDER, which is estimated to utilize a total of about 25 full time employees, currently. Among other activities, the experienced and capable staff conduct medical necessity assessments, consider appropriate action on inspection reports and assess proposals of firms as they attempt to avoid supply disruption or increase production. They reside in many Offices across CDER, including the Office of Compliance, Office of Generic Drugs, Office of Pharmaceutical Sciences and the Office of New Drugs.
We expect that reports of potential and actual drug shortages will continue to increase in the next months to years, requiring that FDA allocate more resources to mitigate drug shortages in a timely manner to protect public health. In doing so we will continue to focus on assuring a multifaceted approach, including close collaboration of all stakeholders within and outside of the Agency, including industry, regulators, payers, Congress, and others.
