Drug Shortage Prevention Act of 2023
12/6/2023, 8:15 AMSummary of Bill HR 3008
The Drug Shortage Prevention Act of 2023, also known as Bill 118 hr 3008, is a piece of legislation introduced in the US Congress aimed at addressing the issue of drug shortages in the country. The bill seeks to prevent drug shortages by requiring drug manufacturers to notify the Food and Drug Administration (FDA) of any potential shortages of critical drugs.Under the provisions of the bill, drug manufacturers would be required to provide the FDA with advance notice of any circumstances that could lead to a shortage of a critical drug. This would allow the FDA to take proactive measures to prevent or mitigate drug shortages, such as working with manufacturers to increase production or identifying alternative sources of the drug.
The bill also includes provisions to improve transparency around drug shortages, requiring the FDA to maintain a public database of drug shortages and provide regular updates on the status of shortages to healthcare providers and the public. Additionally, the bill includes measures to incentivize drug manufacturers to maintain an adequate supply of critical drugs, such as providing tax incentives for companies that invest in increasing production capacity. Overall, the Drug Shortage Prevention Act of 2023 aims to address the issue of drug shortages in the US by improving communication between drug manufacturers and the FDA, increasing transparency around drug shortages, and incentivizing companies to maintain an adequate supply of critical drugs.
Congressional Summary of HR 3008
Drug Shortage Prevention Act of 2023
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.
