FDA Gains $80 Million in Third Pandemic Relief Bill

TOPLINE: FDA would receive another $80 million in no-year money under the third pandemic response legislation. Congress might find it necessary to run a virtual appropriations process. In this week's Analysis and Commentary, there is a continued discussion of Hill Day and a new discussion on why FDA’s mission cannot be ignored while our attention is focused on the pandemic.FDA Gains $80 Million in Third Pandemic Relief Bill. The $2 trillion legislation (Senate passed, pending House action) would provide $80 million in no-year monies (i.e., available until expended)

to prevent, prepare for, and respond to coronavirus, domestically or internationally, including funds for the development of necessary medical countermeasures and vaccines, advanced manufacturing for medical products, the monitoring of medical product supply chains, and related administrative activities.

This is the same language that accompanied $61 million that was provided to FDA under the first pandemic response legislation (described here and here). The use of identical language suggests that FDA and HHS are satisfied that they have the authority to use these monies to fight the pandemic by whatever means are appropriate. While adding $141 million in no-year money to FDA’s budget reflects the cost and urgency of fighting the coronavirus, this week's Analysis and Commentary examines the agency’s other continuing resource needs.Advanced Manufacturing Has Large Role in Pandemic Response Legislation. The language that directed $61 million and now $80 million to FDA makes specific reference to “advanced manufacturing for medical products” as a purpose for which the monies can be spent. The rationale is that such efforts enhance opportunities for medical product manufacturers to re-locate production to the US, resulting in lower costs and shortened supply chains. This concept appears elsewhere as one of the many uses for which monies can be used under the Public Health and Social Services Emergency Fund. Additionally, $10 million is provided for “development and manufacture of new medical countermeasures and biomedical supplies to combat the coronavirus” at the National Institute for Innovation in Manufacturing Biopharmaceuticals, which is a Commerce Department program.Alliance to Meet (Virtually) with FDA Food Safety Leader, Frank Yiannas. On April 1, the Alliance will hold a teleconference meeting with Frank Yiannas, MPH, Deputy Commissioner for Food Policy and Response. The meeting, which runs from 1:00 to 2:00 p.m., will provide the opportunity for him to discuss budgetary and resource needs for FDA's food safety programs. This meeting is open to Alliance members and media. Please e-mail Reed to attend. If you would like to participate, but are not yet an Alliance member, please contact Steven.Congressional Calendar. Congress is almost entirely focused on two challenges: (1) what can they do to slow the pandemic and save the economy, and (2) how can an organization that is premised on the interactions of 535 people (and staff) function in a time when social distancing is mandated and most Members of Congress want to be home and not in DC. Accordingly, the Senate is targeting April 21 as the next day on which Senate business will be conducted, subject to be called back for an emergency. Once the House finishes with the third coronavirus legislation, we expect them to adopt a similar schedule. (Note: We have been told that more than a third of Congress would qualify as high-risk based on age and other factors.)Possible Need for a Virtual Appropriations Process. For several weeks, we have been suggesting that the “must-be-completed” FY 21 appropriations process may need to be recreated in “virtual” form. It is difficult to imagine running hearings, mark-ups, and even having extended floor debate with a 6-foot distance between participants. And that is not to mention that most Members appear to want to be home in their districts rather than in DC. Senate Appropriations Committee Chairman Richard Shelby suggested that further hearings with Administration witnesses might be cancelled or done virtually, but held out hope that face-to-face meetings might be possible before mark-ups begin in May and June (Roll Call story here).