FDA Policy/General

Reconciliation Bill Gives FDA $500 Million for Covid Activities

A provision in a budget reconciliation bill moving its way through the U.S. House of Representatives would provide FDA with a $500 million boost for Covid-19 activities. On 2/11, the House Energy and Commerce Committee considered portions of the bill, which will next be consolidated with reconciliation bills from eight other House authorizing committees and sent to the House Budget Committee, according to the Alliance for a Stronger FDA.. That Committee will meet next week to combine the committee bills into a single reconciliation package. It will then be reviewed by the House Rules Committee before going to the floor. The House plans to bring the package to the floor during the week of 2/22, the Alliance says.

The FDA-related Section 3004 stipulates that the $500 million would be used for:

the evaluation of the continued performance, safety, and effectiveness, including with respect to emerging Covid–19 variants, of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of Covid–19;
facilitation of advanced continuous manufacturing activities related to production of vaccines and related materials;
facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to Covid–19;
review of devices authorized for use for the treatment, prevention, or diagnosis of Covid–19; and
oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of Covid–19 by the Food and Drug Administration.

The Alliance says it supports these additional funds, stressing the importance of FDA’s role in combating the pandemic and the need for funds to cover Covid-19 activities. It adds that, apart from the pandemic, FDA’s mission and responsibilities have grown considerably in the last year and additional base funding will be needed in fiscal year 2022, adding that the Biden Administration will not submit its budget request until after reconciliation is completed (mid-March).

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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