Sec. 101. Report to Congress on barriers to domestic manufacturing of medical products

288 words·~1 min read·/bill/117/s/2082/is/section-101

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Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services, the Secretary of the Treasury, the Secretary of Commerce, and the United States Trade Representative (collectively referred to in this section as the Secretaries ) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on barriers to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices that are imported from outside of the United States.

Such report shall— identify factors that limit or otherwise discourage the domestic manufacturing of active pharmaceutical ingredients, drugs, and devices that are currently imported from outside of the United States, including any Federal, State, local, or Tribal laws that hinder domestic manufacturing opportunities; and recommend specific strategies to overcome the challenges identified under paragraph (1), including strategies— to develop effective incentives for domestic manufacturing; and to make changes to laws or regulations that hinder domestic manufacturing opportunities.

In preparing the report under subsection (a), the Secretaries shall consult with— the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Department of Defense, the Department of State, the Department of Veterans Affairs, the Department of Justice, and any other Federal agencies as appropriate; and relevant stakeholders, including drug, device, and active pharmaceutical ingredient manufacturers, and other entities, as appropriate. In this section, the term active pharmaceutical ingredient has the meaning given to such term in section 207.1 of title 21, Code of Federal Regulations (or any successor regulations).

The Secretary shall make the report under subsection

(a)available on the public website of the Department of Health and Human Services.