Floor Action on House Ag/FDA Appropriations Bill May Be Next Week
This week’s Analysis and Commentary explores how “FDA Brings Good Things to Life.”
Floor Action on House Ag/FDA Appropriations Bill May Be Next Week. H.R. 4368, the FY 2024 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill was approved by the House Appropriations Committee on June 14. The House may consider the bill on the floor during the week of July 24. Otherwise, the bill would need to be held at the clerk’s desk until after the House’s August recess.
There are continuing discussions within House Republican leadership as to what additional restraints on overall spending will be included in FY 24 appropriations bills. Most likely, the Ag/FDA and Veterans Administration/Military Construction bill will reflect those discussions and include amendments that impose funding reductions.
Possible Floor Amendments Accumulate at the House Rules Committee. So far, the House Rules Committee has received 150 proposed amendments to the Ag/FDA funding bill. The number may continue to climb until the House Rules Committee closes off the process.
Among the amendments to date, there are 24 that would impact the FDA. However, none would directly address FDA funding levels. Specifically, six amendments relate to issues and policies in drugs, one to devices, three to food, four to tobacco, five to gender transformation issues, and five to miscellaneous items.
The Rules Committee will decide which amendments will be considered during floor deliberations on H.R. 4368. The Senate has not yet scheduled floor action for its version of the bill. See a list of FDA proposed amendments here.
Rapid Growth in Applications Incorporating AI/ML; FDA Seeks Public Input; Alliance Webinar Planned. Over the last few years, FDA has seen a substantial increase in the submission of drug and biologic applications that incorporate artificial intelligence (AI) and machine learning (ML) technologies.
In 2022, the agency received 170 submissions containing AI/ML elements. By comparison, in 2018, the agency received three such submissions, which had grown to 123 in 2021. Of the 2021 total, twenty-seven percent were in the oncology space, followed by 15% in psychiatry and 12% in gastroenterology (more details here).
Reflecting this trend and its importance, FDA is focused on how AI and ML could streamline drug development and manufacturing. The agency’s March 2023 discussion paper on AI and drug manufacturing is here. The agency’s May 2023 discussion paper on AI and product development of drugs and biologics is here.
Considering the importance of AI/ML to all parts of FDA, the Alliance is planning a webinar on the topic this Fall. The program will cover both integration of AI/ML into FDA’s regulatory framework and also the challenge of recruitment and staff training in this area.
Upcoming Webinar: FDA Chief Scientist Dr. Namandjé Bumpus. August 2nd from 11am-12pm. Please register here!
The Office of the Chief Scientist (OCS) is a hub for scientific programs that support the Centers and the overall FDA mission, including regulatory science, NCTR, technology transfer, and FDA's Medical Countermeasures Initiative (MCMi). The Office of Cosmetics and Colors will be moved into OCS in the near future.
Upcoming Webinar: FDA Commissioner Dr. Robert Califf. August 16 from 1 to 2 p.m. Please register here!
The Commissioner’s February 2023 webinar with the Alliance (here) was one of our most informative, providing an opportunity for multiple topics and multiple stakeholder interests to be discussed. Dr. Califf has agreed to do another fireside chat with us in August. If you are interested in FDA priorities, this is a must-see event.
Upcoming Webinar: FDA Chief Ombudsman Ms. Laurie Lenkel. August 30 from 2 to 3 p.m. Please register here!
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.
Did You Know? The Alliance for a Stronger FDA was founded in 2007, with the merger of two similar organizations that had been formed about a year before. Our efforts have contributed to the growth of FDA’s Budget Authority (BA) (taxpayer) funding from $1.6 billion to $3.5 billion.
In addition to our advocacy on behalf of FDA’s resource needs, we educate policymakers, media, and stakeholders about FDA’s expanding mission and growing responsibilities. One example is our webinar series with FDA senior leadership. Our programs in August will bring our year-to-date total to 15 webinars.