Importantly, on October 1, 2024, the FDA implemented a long-planned reorganization of the Human Foods Program and the FDA field operations in response to the Reagan-Udall Foundation Evaluation published in 2022.

Members of the consortium have had an ongoing dialogue with the hub, Critical Path Institute, the Reagan-Udall Foundation, and AMP ALS since mid-2024.

In anticipation of the 2025 Strategic Agenda, the Reagan-Udall Foundation and the FDA co-hosted a stakeholder meeting where the FDA received input on what the Hub should prioritize. Dr. Flores represented BIO in the October 2024 meeting.

On the FDA’s behalf, the Reagan-Udall Foundation has held roundtables with industry members to share insights, identify and prioritize key issues, and explore implementation strategies.

The FDA noted that a Reagan-Udall Foundation public meeting in the spring of 2023 — with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) — and a December 2023 meeting with FDA, SAMHSA, and the National Institute on Drug Abuse helped shed more light on the ongoing barriers to the use of higher dosages. The FDA labeling was determined to be one of the biggest impediments.

Additionally, the Reagan-Udall Foundation held a series of roundtables with industry members to share insights from those involved in implementation, identify and prioritize key issues, and explore implementation strategies.

Her sentiments echo concerns raised by the Rudd Center for Food Policy & Health at a public meeting hosted by The Reagan-Udall Foundation for FDA in November 2023.

“Our team has had over 185 meetings across industry sectors and answered over 400 questions through our technical assistance network. We also worked with the Reagan-Udall Foundation to meet with industry through a series of roundtables and the public meeting they hosted a couple of weeks ago, for which the comment period recently closed, allowed us to directly hear from the industry about their compliance efforts, the obstacles they encounter, and the potential solutions they propose,” she adds.

We also received similar feedback through several meetings in which FDA participated, including a two-day public meeting with the Reagan-Udall Foundation for the FDA in May 2023 and two listening sessions led by the Substance Abuse and Mental Health Services Administration (SAMHSA) in November and December 2023.

In May 2023, the Reagan-Udall Foundation hosted a 2-day public meeting with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA), entitled “Considerations for Buprenorphine Initiation and Maintenance Care.”