To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes.
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.
Read twice and referred to the Committee on Finance.
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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