Agriculture/FDA Appropriations: Unclear Picture of September Action
This week’s Analysis and Commentary explores Commissioner Califf’s comment on how addressing product shortages is an unexpectedly large and persistent part of his responsibilities.
If you missed our excellent webinar with Laurie Lenkel, FDA’s Chief Ombudsman, a summary is here and the transcript is here. Her office facilitates the resolution of disputes between the agency and stakeholders (industry and non-industry). Every regulatory professional and FDA-regulated entity should be aware of what they offer.
Agriculture/FDA Appropriations: Unclear Picture of September Action. The Senate returns on September 5 and the House on September 12. There is talk of the Senate taking up its committee-passed Ag/FDA spending bill during the second week of September. It is not clear if the bill will be considered as a stand-alone or as part of a minibus bill.
The House had planned to consider its committee-passed Ag/FDA bill just before the House recessed for August. The situation there is more opaque because of unresolved divisions in the Republican caucus as to whether deeper cuts should be advanced.
Both the House and Senate are expected to consider a Continuing Resolution that will be needed when the new fiscal year starts on October 1. Despite the risk of a shutdown and the preference of the Senate for a “clean” Continuing Resolution, the path in the House is not clear. That also reflects unresolved divisions in the Republican caucus about whether to tie the CR to budget cuts.
FDA Updates FAQ and Issues Guidance on Advancing Real World Evidence. The FDA has updated the information it provides on its Advancing Real-World Evidence Program. The agency also released guidance this week on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” (‘RAPS’ summary on the new guidance is here.
Apart from those actions, Commissioner Califf discussed real-world evidence in his remarks at the Alliance webinar on August 22 (here, discussion on page 11 and 12). He noted that there have been “over 200 cases where real-world evidence of one kind or another has informed regulatory decisions.” While the field is evolving, he stressed FDA’s commitment to “letting people know what they need to do if they plan to use real-world evidence [and] have reliable information.” He added that FDA will be communicating “now and then in guidance and research papers.”
The Alliance Welcomed FDA Chief Ombudsman Ms. Laurie Lenkel on Wednesday. The FDA Office of the Ombudsman is the agency's focal point for dispute resolution of complaints and disagreements between companies or individuals and FDA offices. They serve as consultants, and mediators, and oversee formal dispute-resolution mechanisms. Their goal is to assure fair and even-handed application of FDA policy and procedures
See Ms. Lenkel’s webinar transcript here and the summary here. You can also find all the transcripts & summaries of our past Alliance webinars on our website here.
Upcoming Webinar with Digital Health Center of Excellence, Acting Assistant Director of Digital Health Policy MiRa Jacobs, PhD. September 19 from 11 to noon. Please register here!
Artificial intelligence and machine learning (AI/ML) are profoundly impacting health care, food safety, and medical product development and manufacturing. More is coming. FDA’s Digital Health Center of Excellence is at the center of conversations to ensure innovations in this space to assist FDA and benefit the American public.
We have asked Dr. Jacobs to discuss the integration of AI/ML into FDA’s regulatory framework and also the challenge of recruitment and staff training in this area.
Did You Know: Alliance Has Posted Transcripts of Our Webinars with Senior FDA Leaders. In the last 18 months, the Alliance has sponsored 27 webinars with senior FDA leaders, including the Commissioner, the Principal Deputy Commissioner, all five Center Directors, and many others. Transcripts can be found on our website at: https://www.strengthenfda.org/events.
Notably, transcripts are available for our August 2023 speakers—FDA Chief Scientist Dr. Namandjé Bumpus (here); FDA Commissioner Dr. Rob Califf (here); and FDA Chief Ombudsman Laurie Lenkel (here).
Our transcript archive provides a great opportunity to learn more about FDA’s priorities and programs.