This bill requires the Food and Drug Administration (FDA) to report to Congress on barriers to the domestic manufacturing of imported active pharmaceutical ingredients, finished drug products, and devices that are critical to public health.
The report must recommend strategies to overcome such barriers. The FDA may, to the extent appropriate, implement the strategies.
To direct the Secretary of Health and Human Services, acting through 
 the Commissioner of Food and Drugs, to submit to Congress a report on 
      barriers, including regulatory inefficiencies, to domestic 
   manufacturing of active pharmaceutical ingredients, finished drug 
             products, and devices, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. REPORT AND RECOMMENDATION ON BARRIERS TO DOMESTIC 
              MANUFACTURING OF MEDICAL PRODUCTS.

    (a) Report to Congress.--Not later than 180 days after the date of 
the enactment of this Act, the Secretary of Health and Human Services 
(in this section referred to as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall submit to Congress a report on 
barriers, including regulatory inefficiencies, to domestic 
manufacturing of active pharmaceutical ingredients, finished drug 
products, and devices that are--
            (1) imported from outside of the United States; and
            (2) critical to the public health during a public health 
        emergency declared by the Secretary under section 319 of the 
        Public Health Service Act (42 U.S.C. 247d).
    (b) Content.--Such report shall--
            (1) identify factors that limit the manufacturing of active 
        pharmaceutical ingredients, finished drug products, and devices 
        described in subsection (a); and
            (2) recommend specific strategies to overcome the 
        challenges identified under paragraph (1).
    (c) Implementation.--The Secretary may, to the extent appropriate, 
implement the strategies recommended under subsection (b)(2).
    (d) Definition.--In this section, the term ``active pharmaceutical 
ingredient'' has the meaning given to such term in section 744A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41).
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To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to submit to Congress a report on barriers, including regulatory inefficiencies, to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices, and for other purposes.
To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to submit to Congress a report on barriers, including regulatory inefficiencies, to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices, and for other purposes.
Official Titles - House of Representatives
Official Title as Introduced
To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to submit to Congress a report on barriers, including regulatory inefficiencies, to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices, and for other purposes.
Rep. Herrell, Yvette