This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand for certain critical essential medicines that may result in a shortage.
Currently, drug manufacturers are required to notify the FDA in the event of a discontinuation or interruption in the supply of prescription drugs that are life-supporting, life-sustaining, or used for a debilitating disease or condition, including those used in medical emergencies, surgeries, or public health emergencies.
The bill requires drug manufacturers to also notify the FDA if there is an increased demand for such drugs that lasts for at least six weeks and that may result in a shortage. Manufacturers must initially notify the FDA of the increased demand within 48 hours after this six-week period and must submit an additional notice within 30 days of the initial notification. The notice must include the reasons for the increased demand, the expected duration, and any other information the FDA requires. The bill's requirements apply to both prescription and nonprescription drugs.
