May 31, 2022
U.S. Food and Drug Administration
Attn: Dockets Management Staff
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket No: FDA–2022–N–0165, “Providing Mail-Back Envelopes and Education on Safe
Disposal With Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a
Public Docket; Request for Comments”
To Whom it May Concern:

On behalf of the American Association of Oral and Maxillofacial Surgeons (AAOMS), theprofessional association that represents more than 9,000 oral and maxillofacial surgeons(OMSs) in the United States, I would like to thank you and your colleagues at the U.S. Foodand Drug Administration (FDA) for your ongoing efforts to reduce opioid abuse in theUnited States. AAOMS appreciates the opportunity to comment in support of your proposed
modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) torequire that mail-back envelopes be dispensed and education on safe disposal be provided
with opioid analgesics dispensed in an outpatient setting.

Oral and maxillofacial surgery is the surgical specialty of dentistry. As such, management ofour patients’ pain following invasive procedures is an important aspect of providing thebest quality patient care. As lawful prescribers, we know, when used appropriately,prescription opiates enable individuals with pain to lead productive lives and recover more
comfortably from surgical procedures; however, dentists, including OMSs, have a
responsibility to ensure we do not exacerbate a growing public health risk while ensuring
our patients receive the relief they need following complex dental procedures.
AAOMS and its members are very aware of the risks associated with exposure to opioids.
AAOMS is constantly addressing the opioid epidemic with education of our membership,
which has resulted in a significant reduction in OMS opioid prescribing patterns
throughout the country. Because many of our patients are undergoing their first surgery
and first experience with post operative pain, OMSs are committed to using the mosteffective means of managing pain with the least amount of harm.

Proper disposal of opioids to avoid the risk of diversion and potential abuse by nonpatientsis also very important to OMSs. AAOMS encourages its members to promote the U.S. Drug
Enforcement Administration’s (DEA) National Prescription Drug Take Back Days to theirpatients and created a Safe Use and Disposal of Prescription Medication handout for OMSs
to provide to patients regarding options for safe at-home disposal.

Mail-back programs are an additional tool to keep unused opioids out of the hands of those
who may misuse them. As the FDA points out in the proposal, mail-back envelopes are freeand particularly useful for homebound or rural patients who are unable to travel to apharmacy or other designated drop off site to return their medication. Mail-back programs
also may alleviate concerns by some patients that throwing medications in the garbage will
have a negative impact on the environment. AAOMS agrees with the FDA’s approach torequire opioid manufacturers to provide the postage-paid envelopes and develop
educational literature for patients so as minimize the logistical burden and financial
expense associated with this requirement on outpatient pharmacies and other dispensing
entities.

AAOMS’s primary concern with a mail-back program is the possibility of tampering anddiversion. Specifically, that individuals, including mail carriers, could identify the contents
and intercept the package for personal use or sale instead of safely returning them to thedesignated location for final disposal. The FDA proposal, however, indicates that mail-backprograms have existed for many years and that envelopes offered through the OA REMS
program would comply with long-standing U.S. Postal Service and DEA regulations toensure the drugs are safely and securely transported to a DEA-registered facility. As such,AAOMS believes the benefits of a mail-back program outweigh the low-risk potential fordiversion.
Thank you for the opportunity to comment on this important issue. AAOMS is pleased tooffer its support of the agency’s proposal to amend the OA REMS program to require mailback envelopes and education be offered to patients upon dispensing in the outpatientsetting. Please contact Jeanne Tuerk, AAOMS Director of Government Affairs, at 800-8226637, ext. 4321, or jtuerk@aaoms.org with questions or if we can be of further assistance.
Sincerely,J. David Johnson Jr., DDSAAOMS President