117 HR 7121 IH: Protecting our Pharmaceutical Supply Chain from China Act of 2022 U.S. House of Representatives 2022-03-17 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 CONGRESS2d Session H. R. 7121 IN THE HOUSE OF REPRESENTATIVES March 17, 2022 Mr. Gallagher (for himself, Ms. Stefanik, Ms. Cheney, Mr. Budd, Mr. Van Drew, Mrs. Hartzler, and Mr. Posey) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Veterans' Affairs, and Armed Services, 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 the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in the People’s Republic of China, and for other purposes.

1.

Short title

This Act may be cited as the Protecting our Pharmaceutical Supply Chain from China Act of 2022.

2.

Country of origin of drugs

(a)

In general

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following:

524B.

Registry of drugs produced outside the United States

(a)

In general

The Secretary shall compile and maintain a list of all drugs approved under subsection (c) or (j) of section 505 of this Act or licensed under subsection (a) or (k) of section 351 of the Public Health Service Act, and any active ingredients in such drugs, that— (1)are manufactured outside of the United States; and (2)are determined by the Secretary to be critical to the health and safety of consumers in the United States. (b)

Additional list

In conjunction with the list described in subsection (a), the Secretary shall compile and maintain a list of drugs included on such list that are exclusively produced in, or use active or inactive ingredients produced in, the People’s Republic of China. (c)

Requirement

The list described in subsection (a) shall, with respect to each drug included on the list, provide information about the supply chain of the drug, including each step in the supply chain that occurs prior to importation of the drug into the United States.

. (b)

Federal health program purchase of drugs

(1)

In general

Notwithstanding any other provision of law, the Department of Health and Human Services, the Department of Veterans Affairs, the Department of Defense, and any other Federal health care program (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(b))), with respect to the purchase of a drug by such agency or program, the following shall apply: (A)Beginning on January 1, 2023, such agency or program may purchase only drugs for which 60 percent or more of the active pharmaceutical ingredients are manufactured in countries described in paragraph (2). (B)Beginning on January 1, 2024, such agency or program may purchase only drugs for which 100 percent of the active pharmaceutical ingredients are manufactured in countries described in paragraph (2). (2)

Countries described

The countries described in this paragraph are countries— (A)other than the People’s Republic of China; and (B)that meet the health and safety standards of the Food and Drug Administration. (3)

Waivers

The Secretary of Health and Human Services may issue waivers of the requirements under paragraph (1) for any agency or program that is unable to meet such requirements and demonstrates a need for the waiver. No waiver may be issued under this paragraph for drugs that are purchased on or after January 1, 2026. (c)

Labeling requirement

Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following: (gg)If it is a drug and its labeling does not specify the country of origin of each active ingredient contained in the drug..

3.

Temporary 100 percent expensing for pharmaceutical and medical device manufacturing property

(a)

In general

For purposes of section 168(k) of the Internal Revenue Code of 1986, in the case of any qualified pharmaceutical and medical device manufacturing property which is placed in service after December 31, 2019, and before January 1, 2027— (1)such property shall be treated as qualified property (within the meaning of such section), (2)the applicable percentage otherwise determined under section 168(k)(6) of such Code with respect to such property shall be 100 percent, and (3)paragraph (8) of such section shall not apply. (b)

Qualified pharmaceutical and medical device manufacturing property

For purposes of this section, the term qualified pharmaceutical and medical device manufacturing property means any tangible property placed in service in the United States as part of the construction or expansion of property for the manufacture of drugs (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g))) or medical devices (as defined in section 201(h) of such Act (21 U.S.C. 321(h))).