Dear Reader:
The US Food and Drug Administration (FDA) will be holding a public meeting this upcoming Wednesday, July 23rd at the FDA’s Maryland Campus on its long overdue proposal to remove unapproved ingestible fluoride prescription drugs from the market by October. The agency admits that the drugs have never received FDA approval and their safety and efficacy have never been verified. Please read our comprehensive bulletin for details.
The meeting is being hosted by the Reagan-Udall Foundation for the FDA and is schedule to start at 9:30 AM (Eastern) and end at 4 PM. Anyone can register for free to watch a livestream of the event using the following link: https://reaganudall.org/news-and-events/events/use-orally-ingestible-unapproved-prescription-drug-products-fluoride
The public can also attend the meeting in-person. The venue address is:
10903 New Hampshire Ave.
Building 31 – Great Room
Silver Spring, MD 20993.
We’ve been told that a portion of the meeting will include statements from a panel of subject matter experts, followed by timed statements from members of the public, both citizens and professionals. The topics to be discussed will include:
-Clinical Use and Prescribing Considerations for Pediatric Tooth Decay Prevention
-Safety Concerns
-Appropriateness of Pediatric Use Considering Additional Sources of Exposure
-Impact of Removal of Orally Ingestible Unapproved Prescription Drug Products
-Potential Alternatives
Here is the official federal registry notice with background information on the FDA’s proposal and all of the meeting details: click here
We’ve asked the meeting administrators if they plan to release a recording of the event to the public, and we were told that a recording would be posted online before the end of the month. We’ll share the link to the a recording in a bulletin and on social media when it’s made available