Subsequently, the Reagan-Udall Foundation was contracted by the FDA to conduct a series of three invitation-only industry stakeholder meetings focused on FSMA 204 implementation challenges. IFPA attended all of these.

“This is like the weight-loss clinic,” Jenni Wai, Ohio’s chief pharmacist, said of ketamine providers at a June workshop held by the Reagan-Udall Foundation, a congressionally created nonprofit that advises the FDA. “This is like the med spas and the Botox that is popping up everywhere.”

“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.

FDA draft guidance posted in June 2023 provides a potential framework on how to overcome expectancy bias and the nocebo effect by employing an active placebo which could be a substance that also has mind-altering effects but no expected therapeutic benefit. This was reiterated during a virtual public meeting, “Advancing Psychedelic Clinical Study Design,” organized by the Reagan-Udall Foundation for the FDA in the winter of 2024.

In April, FDA resumed the posting of regulatory science policy memos, with a subsequent release in May. The release of these latest memos reflects the CTP’s ongoing commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation.

In January 2023, the FDA announced it would develop a reorganization proposal to create a unified Human Foods Program and restructure its field operations (Office of Regulatory Affairs) after carefully reviewing the findings and recommendations of an outside evaluation by the Reagan-Udall Foundation.

Jones spent 30 years working at the U.S. Environmental Protection Agency, primarily as a pesticide regulator, and served on the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which submitted a report on the operational evaluation of the FDA’s Human Foods Program to the agency in December 2022 — experiences that have prepared him for the new FDA role.