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Letter to Timothy Shea, Administrator of the Drug Enforcement Administration - Clark, Warren, Feinstein, Capito, Stivers Call Out DEA's "Foot-Dragging" on Critical Regulations to Combat the Opioid Crisis

Letter

Date: Oct. 6, 2020
Issues: Drugs

Dear Acting Administrator Shea:
As rates of opioid overdose deaths rise nationwide and the coronavirus disease 2019 (COVID19) continues to have an outsized impact on opioid use disorder (OUD) patients, we write to
again urge the Drug Enforcement Administration (DEA) to finalize "partial fill" regulations.
In 2016, the Comprehensive Addiction Treatment and Recovery Act (CARA) was signed into law
with bipartisan support.
1 Section 702 of the legislation allows patients to take home only a
portion of their opioid prescription and then return to have the remainder filled if their pain
continues, thereby affording both patients and doctors greater control over the amount of opiates
in their possession and in circulation.2 However, the DEA's current definition of "partial fill"
only allows a "partial fill" if the pharmacist does not have enough medication to completely fill a
prescription.3 This outdated definition prevents pharmacists from fulfilling the intent of Section
702.
As you may be aware, we have previously written to your agency to request that it update its
"partial fill" regulations so that Section 702 can be fully implemented.
4 While the Department of
Health and Human Services (HHS) published its final rule on partial fill;
5 DEA has failed to
issue its proposed rule, despite assurances in recent years that "this proposed rule is a top
priority" for the agency.6 DEA's failure to act essentially renders the new HHS rule useless.
The opioid crisis, meanwhile, continues to devastate communities across the country,
exacerbated by the large number of opioids currently in circulation. More than 50,000 Americans
died in 2019 due to an opioid overdose -- with tens of thousands more likely experiencing a nonfatal overdose.
7 More than 10 million people aged 12 and older reported abusing an opioid in the
past year, with over 50 percent of those who abused a prescription pain reliever reporting that
they obtained it from a friend or family member, and just 37 percent as a prescription from their
doctor.8 In 2015, doctors prescribed three times more opioids than they did in 1999, and more
than two thirds of patients prescribed opioids reported having large amounts of unused opioids
after their procedures.
9 Additionally, since the initial outbreak of the COVID-19 pandemic, 40
states have reported increases of opioid overdoses.
10
The ready availability of opioids to millions of Americans and the disruption of life-saving
treatment during the COVID-19 pandemic have compounded this ongoing national crisis.
Defining "partial fill" and fully implementing Section 702 of CARA will reduce the number of
prescription opioids in circulation, a crucial step in addressing the opioid crisis that is devastating
communities across the country. DEA's continuing foot-dragging on this issue puts Americans at
risk.
Given this urgent need and DEA's inaction, we respectfully request that you provide a status
update, including the date by which DEA expects to finalize and make public the partial fill
regulations. We also ask that you provide us a staff-level briefing on this matter no later than
October 20, 2020.
We appreciate your attention to this matter


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