Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions; Public Meeting; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions.'' The purpose of the meeting is to give stakeholders, including health care providers, patients, manufacturers, wholesalers, pharmacists, pharmacy benefit managers, veterinarians, public and private insurers, academic researchers, and the public, the opportunity to provide input on the underlying systemic causes of drug shortages, and make recommendations for actions to prevent or mitigate drug shortages. Members of Congress have asked the Agency to examine the root causes and drivers of these shortages, and to recommend measures that will provide more enduring solutions. To this end, the Commissioner has convened an inter-Agency task force of senior Federal officials of FDA, the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs, and the Department of Defense. After receiving input from stakeholders, the task force intends to provide a report to Congress regarding the root causes of drug shortages. The report will also include recommendations regarding new authorities FDA or other Federal agencies could use to help provide enduring solutions to shortages.