HOME Act

Summary

Help Onshore Manufacturing Efficiencies for Drugs and Devices Act or the HOME Act This bill contains provisions related to critical drugs and medical devices. The bill establishes within the Department of Health and Human Services (HHS) the Center for Domestic Advanced Manufacturing of Critical Drugs and Devices. The center shall establish and implement a program to provide grants and forgivable loans to support investment in advanced manufacturing for the domestic production of critical drugs, medical devices, and active pharmaceutical ingredients. Furthermore, a supplemental application for a critical drug approved by the Food and Drug Administration (FDA) may receive expedited review if, among other requirements, the applicant plans to produce the drug domestically after the approval of the supplemental application. (A supplemental application generally involves a change, such as a manufacturing change, to an existing application for FDA approval.) The bill also authorizes HHS and the Department of Defense to enter into multiyear high-volume contracts to purchase critical drugs and medical devices.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 20 May 2020

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 20 May 2020

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• Introduced in Senate

  summary · EN · 20 May 2020

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