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.”

Earlier this year, Ultragenyx reached agreement with the Agency that CSF HS can be used as a surrogate endpoint for accelerated approval based on the body of data presented by the company, along with a consortium of academics and other industry sponsors at a workshop hosted by the Reagan-Udall Foundation for the FDA in February 2024.

Drs. Robert Califf and Marta Sokolowska underscore the distinctive advantages primary care providers can bring to positively impacting the lives of people with opioid use disorder, referencing the Foundation’s virtual public meeting exploring “Considerations for Buprenorphine Initiation and Maintenance Care.”

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In the fall of 2022, the Reagan-Udall Foundation—an independent organization established by Congress to advance the mission of the FDA—evaluated the CTP and identified several key areas for improvement. Released in December 2022, the report outlined 15 things the CTP must improve to effectively implement the regulatory goal of the organization’s mission: the protection of public health.

Jax’s Citizen Petition represents a perfect opportunity for the FDA’s Human Foods Program under Deputy Commissioner Jones to lead by example and break away from the Reagan-Udall Foundation’s finding that the FDA’s “culture creates an environment where decision-making is unacceptably slow” and from an external perspective appears “sluggish and non-responsive to public health concerns.”

Through this collaboration, the Public Engagement Staff and the Foundation are working together on FDA Patient Listening Sessions to enhance FDA’s clinical and regulatory understanding of diseases and conditions and provide a common understanding of the most urgent needs of patients, caregivers and advocates.