# The MADE in America Act: Bringing Drug Manufacturing Back Home

This bill aims to tackle a serious problem: America relies too heavily on other countries to make medicines and medical supplies. The MADE in America Act creates a plan to encourage pharmaceutical companies to manufacture drugs, their key ingredients, and medical devices here in the United States instead of importing them from abroad. The bill recognizes that when we depend on foreign manufacturers, we become vulnerable to shortages—something that became painfully obvious during the COVID-19 pandemic when personal protective equipment and other medical supplies ran short.

The bill takes a two-pronged approach. First, it requires government agencies to study what's actually stopping companies from making medicines in America. Within six months, the Secretaries of Health and Human Services, Treasury, Commerce, and the U.S. Trade Representative must report back to Congress identifying the barriers—whether they're federal regulations, state laws, or economic factors—that make it cheaper or easier to manufacture drugs overseas. They'll also recommend specific solutions, like new incentives or regulatory changes that could make domestic manufacturing more attractive. Second, the bill creates tax credits for companies that manufacture pharmaceuticals and medical devices in economically distressed areas of the United States, essentially offering financial rewards for bringing production jobs home.

The bill also improves transparency and coordination within the FDA. It requires the agency to better communicate internally about drug shortages and to publish annual reports showing how long it takes to inspect drug facilities and approve manufacturing changes. This helps companies understand the timeline for getting their products approved and helps identify bottlenecks in the system. Additionally, the bill establishes a program to support advanced manufacturing technologies—newer, more efficient ways of making drugs that could help prevent shortages and speed up production. For everyday Americans, this means potentially more reliable access to affordable medicines and less dependence on foreign supply chains for critical medications.

MADE in America Act

Carter, Earl L. "Buddy"

Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act This bill establishes a tax credit for taxpayers engaged in medical production activities in certain areas and contains other provisions related to pharmaceuticals. An eligible taxpayer may claim a tax credit equal to 25% of qualified expenditures related to the production of pharmaceuticals, medical devices, or other related items in a designated qualified opportunity zone with a poverty rate higher than 30%. The bill provides for increases to this tax credit in certain situations, such as if a substantial portion of the employees reside in areas with certain poverty levels. In addition, the Food and Drug Administration (FDA) must continue programs to facilitate the development and review of new drug or biological products that are manufactured using certain advanced manufacturing technologies. The bill imposes various requirements on these programs, including deadlines for evaluating such a technology. Furthermore, the Department of Health and Human Services must ensure timely and effective internal coordination and alignment between FDA field investigators and the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program regarding reports and feedback related to facility inspections.