This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand, export restriction, or other circumstance that may result in a shortage of certain critical drugs.
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, export restriction, or other circumstance that may result in a meaningful shortfall or delay in meeting the demand for such drugs. Manufacturers must notify the FDA as soon as possible but no later than 10 days after the onset of the relevant circumstance. 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.
Drug manufacturers must also report twice a year (rather than annually) information on the quantities of drugs produced; manufacturers must also provide the names of the suppliers of corresponding active ingredients.
