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.

Bill: 117-hr-6710
Sponsor: full_name: Rep. Herrell, Yvette [R-NM-2]
Introduced: 2022-02-11
Policy area: Health
Subjects: Congressional oversight

Drug safety, medical device, and laboratory regulation

Emergency medical services and trauma care

Infectious and parasitic diseases

Manufacturing

Trade restrictions
Latest action: action_date: 2022-02-14
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2022-02-11
action_desc: Introduced in House
text: <p>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.</p> <p>The report must recommend strategies to overcome such barriers. The FDA may, to the extent appropriate, implement the strategies.</p>

tv_txt: I 117th CONGRESS 2d Session H. R. 6710 IN THE HOUSE OF REPRESENTATIVES February 11, 2022 Ms. Herrell (for herself, Mr. Banks , Mr. McKinley , Mr. Hern , Mrs. Miller of Illinois , Mr. Higgins of Louisiana , Mrs. Miller-Meeks , Mr. Austin Scott of Georgia , Mr. Donalds , Mr. Cawthorn , Mr. Norman , Mr. LaTurner , Mr. Keller , Mr. Hudson , Mrs. Cammack , and Mr. Gohmert ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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.

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 ).