“The Supreme Court’s decision elevates the importance of the Reagan-Udall Foundation’s findings after being convened at the request of the FDA commissioner, which specifically and clearly criticized the FDA’s Center for Tobacco Products for failing to inform companies what must be provided under the regulation to demonstrate APPH [appropriate for the protection of the public health] and, as importantly, for failing to inform the public on how FDA is applying this standard.”

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The meeting, which will be facilitated by the Reagan-Udall Foundation, will provide those in the rare disease community the opportunity to provide input on the priorities of the hub. The FDA plans for the hub to work across rare diseases but especially focus on products intended for smaller populations or for less-understood diseases.

On Monday, the FDA announced that it will hold a public meeting on October 16, 2024, titled, “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub.”

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According to findings by the Reagan Udall Foundation, that is exactly what is happening as stakeholders navigating the process “expressed concerns about a lack of clarity, transparency, and communication” regarding the CTP’s priorities and decision-making processes.