FDA in 2024: What to Expect in an Election Year – Webinar Recording/Transcript
2024 is an election year, which means that some of the issues that the FDA handles will be on the national debate stage. Additionally, the FDA has a new budget passed by Congress, the FDA Commissioner has identified new priorities, and the agency continues to adapt to a post-COVID environment that involves the increased use of artificial intelligence (AI), innovations in cell and gene therapies, and changes in how medical products are developed and accessed.
To help you prepare, this presentation provides expert insights and an in-depth review of potential FDA policies and programs for 2024, and what they mean for your business.
Prominent FDA-watchers and regulatory experts Wayne Pines, Cathy Burgess, Steve Grossman, Josh Oyster and Lowell Zeta look back at recent developments and what we can expect from the FDA in 2024 considering the regulatory and political environment. They discuss some of the FDA’s 2024 priorities what new programs and policies will be initiated, and how companies need to plan and adjust.
- Understand the priorities, major issues, and challenges for FDA leadership in 2024.
- Learn how the FDA has changed due to Covid-19.
- Understand the role politics will play in FDA policies and decisions in the upcoming presidential election year.
- Consider how the consumer/participant voice will continue to impact FDA product decisions.
- Examine how the FDA will implement the provisions of user fee legislation.
- Assess further vaccine development.
- Analyze the monograph review process and how Rx-to-OTC switches may affect other activities.
- Discuss the Center for Biologics Evaluation and Research (CBER)’s five-year plan and its progress overseeing cell and gene therapies amid an influx of applications.
- Examine the status of AI/digital therapeutics/software regulation in the Center for Devices and Radiological Health (CDRH).
- Assess FDA decision-making around inspections, shortages, imports, supply chain issues, and promotional efforts.
- Examine the status of harmonization efforts with the EU.
Meet Your Presenters
Wayne Pines is a member of APCO Worldwide’s International Advisory Council and president of healthcare at APCO Worldwide. He has served as a trusted advisor to FDA leadership for several decades. Pines served for 10 years in senior positions at the FDA, including as chief media spokesman and associate commissioner for public affairs. He has authored or edited more than a dozen books about the FDA and was a co-founder and long-term president of the Alliance for a Stronger FDA.
Cathy Burgess leads Alston & Bird’s FDA compliance and enforcement team and co-leads the firm’s FDA practice. Burgess advises clients on a range of matters affecting prescription and OTC drugs, biologics, medical devices, foods, and cosmetics. She has extensive experience regarding current good manufacturing practice regulation and supply chain management. Burgess conducts liability risk assessments and works with clients to identify and analyze potential legal risks associated with their products. She advises clients on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls, and responses to Form FDA 483s and warning letters.
Steven Grossman is the president of HPS Group, a policy and regulatory consulting firm. He is also the executive director of the Alliance for a Stronger FDA, a 150-member stakeholder coalition that advocates for increased resources for the FDA. Prior to becoming a consultant and association executive, Grossman was the health staff director of the Senate Labor and Human Resources Committee (now HELP), where he helped negotiate the Orphan Drug Act and the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman). After leaving the Senate, Grossman was a deputy assistant secretary for health at HHS.
Josh Oyster is a partner in Ropes & Gray’s Life Sciences Regulatory and Compliance practice group. He steers clients through a wide range of FDA regulatory issues and is regularly called upon for help with a range of enforcement, regulatory compliance, and transactional matters. Oyster routinely helps companies navigate FDA inspections, warning letters, product recalls, and other compliance and enforcement matters.
Lowell Zeta is a partner in the Life Sciences and Global Regulatory practices at Hogan Lovells US in Washington, DC. Zeta previously served as senior counselor to the FDA commissioner, where he provided leadership on the agency’s cross-cutting and high-priority initiatives promoting innovation and addressing public health issues. He led the FDA's COVID-19 PREPP initiative to help guide the agency's response and strategic planning.
Who Will Benefit
- Biologics companies
- Cell and gene therapy companies and researchers
- Distributors and importers
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Oct. 26, 2023