117 HR 3683 IH: Securing America’s Pharmaceutical Supply Chain Act U.S. House of Representatives 2021-06-01 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 117th CONGRESS1st Session H. R. 3683 IN THE HOUSE OF REPRESENTATIVES June 1, 2021 Mr. Stauber (for himself and Mr. Garamendi) introduced the following bill; which was referred to the Committee on Oversight and Reform, 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 A BILL To require executive agencies to purchase pharmaceuticals from the United States, and for other purposes.

1.

Short title

This Act may be cited as the Securing America’s Pharmaceutical Supply Chain Act.

2.

Requirement to purchase pharmaceuticals from the United States

(a)

In general

Except as provided in subsection (b), the head of an executive agency may only purchase a covered drug if the drug is over 50-percent sourced, manufactured, and assembled in the United States. (b)

Exception

The head of an executive agency may waive the requirement of subsection (a)— (1)if the covered drug is not available in sufficient quantity or quality as over 50-percent sourced, manufactured, and assembled in the United States; or (2)during an emergency period (as defined in section 1135(g)(1)(A) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(A))). (c)

Modifications to trade agreements

(1)

In general

Not later than 30 days after the date of the enactment of this Act, the United States Trade Representative shall modify United States product coverage under all free trade agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of essential medicines and medical countermeasures. (2)

Modification of waivers

Subsequent to the modifications made under paragraph (1), the United States Trade Representative shall make any necessary corresponding modifications of existing waivers under section 301 of the Trade Agreements Act of 1979 (19 U.S.C. 2511). (3)

Notification to the President

Subsequent to the modifications made under paragraphs (1) or (2), the United States Trade Representative shall notify the Director of the Office of Management and Budget. (d)

Definitions

In this section: (1)

Covered drug

The term covered drug means a drug (including the active pharmaceutical ingredients thereof) marketed in the United States pursuant to an approval or licensure under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262). (2)

Executive agency

The term executive agency has the meaning given that term in section 133 of title 41, United States Code. (3)

United States

The term United States means each of the several States, the District of Columbia, and each territory or possession of the United States. (e)

Severability clause

If any provision of this Act (or the application of that provision to particular persons or circumstances) is held invalid, the remainder of this Act (or the application of that provision to other persons or circumstances) shall not be affected. (f)

Effective date

The provisions of this section shall apply beginning on the date that is one year after the last day of the emergency period (as defined in paragraph (1)(B) of section 1135(g) of the Social Security Act (42 U.S.C. 1320b–5(g)).