House and Senate Calendar Updates; Understaffed FDA Offices; Inspections Updates
Top-Line:
Commissioner Califf to Address Alliance: July 12 from 1:30 to 2:30 P.M. Register here
House and Senate Calendars for July and September
Passage of User Fee Legislation Needed by August 1 If Possible
A New Take on Understaffed FDA Offices
As Normal Inspections Resume, Hybrid Model to Remain
Want to Know More About FDA? Alliance’s New Website Delivers www.strengthenfda.org
This week’s Analysis and Commentary looks at questions Commissioner Califf might answer during the July 12 webinar and describes feedback we received during Senate meetings in late July.
Commissioner Califf to Address Alliance for a Stronger FDA: July 12 from 1:30 to 2:30. Dr. Califf will address FDA’s mission and resource needs as part of a fireside chat with the Alliance. The event will be Tuesday, July 12 from 1:30 to 2:30 p.m. ET and will be open to Alliance members and media. Register here.
The Alliance welcomes guests at our events. If you are not an Alliance member and would like to attend, please contact Alliance Executive Director, Steven Grossman.
House and Senate Calendars for July and September. Congress returns next week and faces more work than its schedule will likely accommodate. The House has 23 legislative session days scheduled before the end of the fiscal year (September 30, 2022). The Senate has 38 legislative days over the same period, but a significantly larger set of activities.
Our understanding is that House leadership still plans to schedule and pass all appropriations bills during July. Based on past experience, there are likely to be 3 to 5 minibus bills that among them cover all twelve spending bills. In the Senate, Appropriations Chair Leahy has said he plans to set subcommittee allocations this month so that the Senate Appropriations Committee can move forward with markups.
Passage of User Fee Legislation Is Needed by August 1 If Possible. In response to a media inquiry, Alliance Executive Director Steven Grossman stated: “While the drug and medical device user fee programs expire on September 30, 2022, it is important that the legislation pass and reach the President sooner. Specifically, on August 1--sixty days before the laws expire--lay-off notices would need to be sent to thousands of FDA employees whose work is supported by the expiring user fee programs. All of this is bad for morale, recruitment, and retention at a time when FDA’s responsibilities keep growing.”
“We know that leadership of both House E&C and Senate HELP have been taking the August 1 deadline seriously. So, it is troubling to hear rumors that the final legislation will not be ready before September. We hope that negotiations can accelerate, and the August deadline met.”
A New Take on Understaffed FDA Offices. The Committee Report accompanying the House Ag/FDA FY23 appropriations bill is more than twenty pages long. Every paragraph is important to some stakeholder, as well as Congress. However, our focus immediately turned to the first item in the report:
This bill was developed during the infant formula shortage in the spring of 2022. That crisis revealed the FDA had only nine people in the office that regulates infant formula. This raises a concern about how many other key offices at the agency are also severely understaffed. The Committee will be in dialogue with the agency throughout the year about critical staffing needs.
The Alliance often talks about the number and breadth of FDA’s responsibilities. Given our view, we find it credible that there are many smaller FDA offices—with critical responsibilities--that are understaffed. A dialogue between FDA leadership and Congressional appropriators on this topic is a welcome development.
As Normal Inspections Resume, Hybrid Model to Remain. As reported by Regulatory Focus (here), FDA is resuming normal inspection operations. At the late June DIA meeting, agency representatives said the FDA plans to continue the use of a hybrid inspection “combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed.”
Want to Know More About FDA? Alliance’s New Website Delivers www.strengthenfda.org. On the site you can find transcripts and/or summaries of all 17 webinars that the Alliance has held since April 2021. The webinars are hour-long programs with senior FDA leadership. Whatever part of FDA you are interested in, it has been covered by one of our speakers. Go to the Alliance’s Events page here.
Happening soon and then coming to the site:
a July 12 webinar from 1:30 to 2:30 with FDA Commissioner Califf (described above, Register here) and
an August 4 webinar from 3 to 4 with Deputy Commissioner Woodcock on data, technology, and enterprise modernization (Register here).
We expect to have additional webinars scheduled soon.