PREPARE ACT of 2024 Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines Act of 2024
If enacted, the PREPARE Act would significantly affect the production and distribution of essential generic medicines in the U.S. The bill mandates the creation of a reserve that ensures minimum quantities of APIs are stored domestically, with goals set for increasing these reserves over a span of ten years. This legislation is particularly relevant in light of recent challenges related to drug supply chain disruptions, notably during the COVID-19 pandemic. By bolstering domestic manufacturing and storage capabilities, the bill seeks to mitigate risks associated with shortages and enhance public health preparedness.
House Bill 7709, known as the 'Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines Act of 2024' (PREPARE Act), aims to establish a strategic reserve of active pharmaceutical ingredients (APIs) crucial for the manufacturing of essential generic medicines. The act intends to maintain a stable domestic supply of these critical materials, reducing dependency on foreign sources and preparing the nation for public health emergencies. Key provisions include identifying essential medicines, establishing storage requirements, and ensuring that the Secretary of Health and Human Services develops a comprehensive plan within 90 days of enactment.
There are concerns regarding the balance between ensuring a robust supply of essential medicines and the potential impact on pharmaceutical market competition. Critics may argue that government intervention in the pharmaceutical supply chain could stifle innovation and disrupt market dynamics. Additionally, the requirement for domestic procurement and the establishment of contracts with U.S. manufacturers may raise questions about feasibility and potential costs involved, especially in relation to existing global supply chains and economic agreements.