FDA At-Home Opioid Disposal Consultation Needed Say Lawmakers

A letter has been drafted by lawmakers and directed to the U.S. Food and Drug Administration (FDA) emphasizing the importance of liaising with Tribal Nations while finalizing their new policy concerning the at-home disposal of prescription opioids.

Previously in April, the FDA, in collaboration with the United States Postal Service (USPS), rolled out a policy. This mandates opioid manufacturers supplying to pharmacies to enclose prepaid envelopes, allowing patients to mail back any unused prescription pills. This strategy is aimed at minimizing nonmedical consumption of opioids and is a reaction to the persistent opioid crisis.

Statistics from the Centers for Disease Control and Prevention (CDC) indicate a sobering rise in opioid-related deaths, with 103,000 Americans succumbing to such incidents in 2022. The increase since 2000 stands at over 200%, as per the CDC.

The opioid crisis has cast a dark shadow over all demographic groups in America. However, Black, Indigenous, and People of Color (BIPOC) have borne the brunt of it, with Indigenous communities being exceptionally impacted. CDC data from 2020 reveals that Native Americans witnessed a 39% surge in opioid-related deaths from the previous year. This was the second-largest spike, with African Americans leading. Furthermore, in 2020, Purdue Pharma, a notable producer of opioids including OxyContin, admitted its criminal actions which fueled the opioid crisis, claiming the lives of countless Americans and pushing numerous others into opioid dependence.

The correspondence, penned by Senators Martin Heinrich (D-N.M.), Jon Tester (D-Mont.), and Patty Murray (D-Wash.), highlights that the proposed regulations should facilitate at-home disposal solutions for rural communities and Tribal areas, particularly those without consistent USPS accessibility. As the policy stands now, Tribal residents on reservations are left with scant means to securely rid their households of opioids.

Other signatories of the letter to FDA Commissioner Robert Califf include U.S. Senators Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio), Catherine Cortez Masto (D-Nev.), Ron Wyden (D-Ore.), John Hickenlooper (D-Colo.), Tammy Baldwin (D-Wis.), and Ben Ray Luján (D-N.M.).

Read the full text of the letter below.

Dear Commissioner Califf:

We write to express the importance of strong disposal policies for prescription opioids. The Food and Drug Administration (FDA) has an opportunity to send a clear message that it is prioritizing public safety and taking meaningful steps to reduce opioid use disorder by removing excess opioids and other drugs from circulation. As our nation continues to grapple with the opioid epidemic, we must take steps to address the effects on rural and Tribal communities in ways that are responsive to their needs. We appreciate the Administration’s efforts to combat this public health emergency and strongly believe that this can best be addressed through meaningful Tribal consultation. We respectfully request that FDA fully incorporates feedback from Tribal consultations and those representing smaller towns and rural areas as it finalizes the at-home drug deactivation option for Americans.

As you are aware, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (PL 115-271) gave the FDA authority to implement risk mitigation measures to prevent diversion and addiction, including permitting co-dispensing of at-home drug deactivation and disposal products directly to patients who are prescribed drugs like opioids. We are aware that in April, the FDA issued a policy that would require opioids to be co-dispensed with a prepaid mail-back envelope to return unused pills. While we recognize that this policy supports opioid disposal for some, it is critical that this be paired with an at-home disposal option, which is supported by the latest evidence-based research for drug deactivation, is more cost-effective, and presents significantly fewer risks.

For our constituents, particularly the thousands who live in rural and Tribal communities, the ability to safely deactivate and dispose of drugs at home would be a strong tool in the fight against addiction. Our constituents in rural areas do not always have regular mail access, and any policy that focuses solely on mail-only disposal creates an undue burden for those individuals to safely remove opioids from their homes.

Even more alarming is the impact this could have on Tribal communities. Access to mail through the USPS among Tribal communities is extremely limited; whether they are located on Tribal land, or otherwise, it is almost non-existent in some areas. In some parts of the Navajo Nation, packages must be mailed to businesses or relatives who oftentimes live in towns many miles away. For many on the Navajo Nation, they must access their regular mail at P.O. boxes, which are sometimes located in other states, depending on where they reside. This experience is not unique to the Southwest, as Tribal communities throughout the United States struggle to have reliable access to the mail. Rural Tribal communities in northwestern states such as Montana and Washington often lack home mail service. Non-traditional and informal mailing addresses, along with the scarcity of post offices, P.O. boxes, and drop-off mailboxes, result in limited access to regular mail.

A comprehensive disposal policy that includes an at-home disposal method also better accounts for the increased risk for the USPS of handling additional opioids. This policy could make post offices, P.O. Boxes, and drop-off mailboxes a higher risk for theft and damage and also would increase the number of opioids going through the mail system. It puts the safety of mail carriers at risk and does not expand USPS programs to provide additional safety measures, such as providing Narcan in every USPS facility. We are concerned that USPS employees were not adequately consulted about the potential risks this policy presents, should this policy be fully implemented.

While we appreciate the effort that the FDA has put into addressing the ongoing opioid crisis, it is clear that any comprehensive approach to opioid disposal must include at-home disposal alongside a mail-back policy in order to adequately improve American’s ability to safely dispose of opioids. We request that the FDA initiate meaningful Tribal consultation and discussions with impacted communities – particularly those without reliable access to USPS, and fully include the feedback from those Tribal consultations and discussions with smaller towns and rural areas prior to finalizing this policy. We also request that you include feedback from the USPS employees and other relevant stakeholders about the increased risks to their employees.