AAO Delegation Meets with FDA and Members of Congress to Advocate for Patient Health and Safety

The AAO recently had a highly productive two days advocating in Washington, D.C. on issues surrounding mail-order orthodontic treatment models. On July 9 AAO President Dr. John Callahan, fellow AAO trustees Dr. Michael Durbin and Dr. Ken Webb, AAO Vice President of Advocacy Nathan Mick, Alex Campau from Cozen O’Connor Public Strategies, and AAO CEO Trey Lawrence met with key leaders at the US Food & Drug Administration (FDA) with oversight on prescription medical devices, including clear aligners. 

The AAO delegation also included virtual participation from Drs. Dale Anne Featheringham, Cosmo Haralambidis, Jashleen Bedi and Mackenzie Butcher. AAO members shared clinical stories about risks and harms related to direct-to-consumer (DTC) clear aligners with the FDA team, which included dentists. The AAO/FDA discussion went well past the hour allotted for the meeting and the information was received positively by the FDA.

The FDA manages the Manufacturer and User Facility Device Experience (MAUDE) database which is “a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years.”

The AAO Advocacy team and Cozen O’Connor Public Strategies will be analyzing hundreds to thousands of complaints in the FDA’s MAUDE database about DTC aligners and providing a summary of relevant information to the FDA team. If the problem indicated by that analysis is deemed serious enough, the FDA will consider issuing a public warning to patients about treatment with a DTC company without receiving an in-person examination and radiographs first.

The FDA recommends that orthodontists who see a patient after direct-to-consumer treatment report any adverse events experienced by the patient in the MAUDE database. The MAUDE database can be accessed at the following link and AAO members are encouraged to submit clinical details about adverse DTC events and those reports will help the FDA evaluate how best to educate the public about mail-order treatment model risks and harms:
Manufacturer and User Facility Device Experience (MAUDE) Database (fda.gov).

If you have retreated a DTC patient, please take the time now to submit at least one DTC report to the FDA.As always,grassroots engagement by AAO members is extremely effective and helps positively move the needle on the AAO’s evidence-based policy priorities.

On July 10, Mr. Lawrence, Mr. Mick, Ms. Campau and Meagan Foster, also of Cozen O’Connor Public Strategies met directly with eight members of Congress and their staff, including members who signed the December 2022 letter to the Government Accountability Office (GAO) requesting the study of FDA and FTC oversight of DTC devices.

These meetings provided timely opportunities to relay what the delegation learned from the FDA the day before and consider next steps at the Congressional level for patient protections.

Addressing patient health and safety concerns relating to mail-order orthodontic treatment models is a top priority for AAO and consistently remains high on the list of ranked issues through the annual AAO public policy survey. The AAO is making advances at the federal level, and also in states through landmark patient health and safety legislation being passed in Nevada and Florida (and teledentistry legislation currently pending approval by Illinois Governor J.B. Pritzker).

Contributing to the AAO Political Action Committee (AAOPAC) helps fuel our advocacy success in Washington, D.C. and in states throughout the country. 2024 marks the 30^th anniversary of AAOPAC. To learn more and make your special 30^th anniversary gift now, please visit AAOPAC.org.

* View more photos from the delegation’s Washington, D.C. advocacy effort.