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Abuse Deterrent Coalition Sends Letter to FDA Commissioner, Scott Gottlieb


Dear Dr. Gottlieb,

The Abuse Deterrent Coalition (ADC) commends the U.S. Food and Drug Administration (FDA) for its focus on the nation’s opioid epidemic by recognizing the promise of abuse-deterrent formulation (ADF) opioids to discourage abuse and incorporating expanding access to these medicines as a component of the federal Opioid Action Plan. The ADC is an organization of ADF technology innovators, patient and public policy advocates and pharmaceutical research groups that support the use of ADF for drugs that have high potential for abuse. We believe ADF opioids play a key role in addressing the opioid epidemic with a focus on prevention by deterring abuse and misuse of opioids.

It has been reported that you will be meeting in September with a group of pharmacy benefit managers (PBMs) and insurance administrators to discuss the opioid epidemic. We urge you to consider using this meeting to encourage PBMs and insurers to ensure that ADF opioids are available to patients with limited, if any, formulary restrictions to allow patients unencumbered access where appropriate. Ensuring access empowers providers to freely prescribe these therapeutically equivalent products with abuse-deterrent properties that are designed to deter tampering or manipulation in prescription drugs.

Unlike existing more easily-abused opioid products, ADFs often are subject to substantial coverage restrictions by PBMs and payers. Such policies have stymied patient access and created barriers to providers trying to prevent opioid abuse. We encourage you to address these formulary barriers to ADF opioids at your upcoming discussion. Such restrictions include prescriber impediments, prior authorization, formulary placement challenges, non-medical switching and “fail first” policies that prevent patients from accessing ADF opioids. These restrictions are counterproductive to addressing opioid abuse prevention.

ADF opioid manufacturers are working to replace non-abuse-deterrent opioids, which comprise 96% of all C-II opioid products sold today. Non-ADF opioids can be quickly and easily tampered with and abused through the intranasal and intravenous routes. The lack of consistent ADF opioid reimbursement may seem “pennywise” to PBMs and insurers, but it is “pound foolish” and comes at a significant public health cost. This Administration should use all options available to address both prevention and treatment to fight the opioid crisis – including the broader deployment of ADF opioids.

The FDA has publicly stated that it looks forward to a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that lack abuse-deterrent properties. In response, ADF opioid innovators have begun developing, licensing and/or marketing medications incorporating novel technologies intended to deter abuse.

ADF technology is a means to help deter tampering and abuse of critical medications, while ensuring those who have a legitimate need for pain relief continue to have access to appropriate therapies. This technology is one innovative tool that respects the doctor-patient relationship for appropriate care while offering the possibility of deterring prescription drug abuse.

We believe it is consistent with the Agency’s Opioid Action Plan and in the best interest of public health to support the use of ADF opioids to balance the legitimate needs of patients in chronic pain while helping to protect families, physicians and communities from the burden of abuse.


The undersigned Abuse Deterrent Coalition Members

Click here for a PDF of the letter 

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