The Executive Order is one in a series of steps that will help address the shortage of prescription drugs and ensure patients have access to the lifesaving medicines they need. The Obama Administration will also send a letter to drug manufacturers reminding them of their legal responsibility to report the discontinuation of certain drugs to the FDA. Staffing resources will be increased for the FDA’s Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers. A report will be released from the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) that assesses the underlying factors that lead to drug shortages, and an FDA report on its role in monitoring, preventing, and responding to these shortages.
The President’s order directs FDA to broaden reporting of potential shortages of certain prescription drugs. Additionally, the Executive Order requires FDA to expand its current efforts to expedite review of new manufacturing sites, drug suppliers, and manufacturing changes to help prevent shortages.
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