Expressing the sense that the process behind Operation Warp Speed should be integrated within operations at the Food and Drug Administration.

Bill: 117-hres-876
Sponsor: full_name: Rep. Burgess, Michael C. [R-TX-26]
Introduced: 2022-01-19
Policy area: Health
Latest action: action_date: 2022-01-20
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2022-01-19
action_desc: Introduced in House
text: <p>This resolution states that the Food and Drug Administration (FDA) should, to the extent scientifically and legally possible, integrate the process behind Operation Warp Speed into FDA operations. (Operation Warp Speed was a partnership between the Department of Health and Human Services and the Department of Defense to coordinate federal efforts to accelerate the development of COVID-19 medical countermeasures, including vaccines.)</p> <p>The resolution also states that the FDA should issue guidance identifying ways to accelerate drug and biological product development through clinical trials and the approval and licensure processes.</p>

tv_txt: IV 117th CONGRESS 2d Session H. RES. 876 IN THE HOUSE OF REPRESENTATIVES January 19, 2022 Mr. Burgess submitted the following resolution; which was referred to the Committee on Energy and Commerce RESOLUTION Expressing the sense that the process behind Operation Warp Speed should be integrated within operations at the Food and Drug Administration.

That it is the sense of Congress that the Commissioner of Food and Drugs should— (1) to the extent scientifically and legally possible, integrate the process behind Operation Warp Speed into operations at the Food and Drug Administration; (2) issue guidance identifying ways that drug and biological product innovation and development can be accelerated through clinical trials and the approval and licensure processes; (3) for purposes of accelerating the approval of new drugs and biological products, cross-reference applicable safety and scientific data from approved drugs and licensed biological products; and (4) collect interim data that would allow for parallel assessments of the safety and effectiveness of multiple drugs and biological products and the parallel approval or licensure of multiple drugs and biological products, including through the conduct of concurrent clinical trials.