Senators urge DEA to lower pill quotas

WASHINGTON, D.C. – U.S. Senator Joe Manchin (D-WV) joined a group of senators recently in sending a letter to the Drug Enforcement Agency (DEA), urging the agency to better prevent painkillers from flooding the market by setting lower opioid production quotas for 2018. Last year, the DEA heeded the senators’ call to address America’s opioid epidemic by reducing nearly all opioid quotas by 25 percent or more. Manchin's office noted in a new release that this was the first reduction of its kind in over 0 years, but DEA-approved opioid production volumes remain troublingly high—including 55 percent higher oxycodone levels in 2017 than in 2007.

 The Senators wrote in part: “As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation. However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.” 

 The senators also pressed the agency to improve transparency in its quota-setting process by providing an explanation of how it reaches a determination and publishing quotas granted to individual manufacturers of schedule II opioids.

 In addition to Senator Manchin, Senators Dick Durbin (D-IL), Edward J. Markey (D-MA), Sherrod Brown (D-OH), Amy Klobuchar (D-MN), Angus King (I-ME), Dianne Feinstein (D-CA), Claire McCaskill (D-MO), Patrick Leahy (D-VT), Tammy Baldwin (D-WI), Jeanne Shaheen (D-NH), Kirsten Gillibrand (D-NY), Catherine Cortez Masto (D-NV), Maggie Hassan (D-NH), Richard Blumenthal (D-CT), and Al Franken (D-MN) signed today's letter. 

 Between 1993 and 2015, the DEA allowed production of oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold. As a result, the number of opioid pain relievers dispensed in the United States has skyrocketed over the last two decades - from 76 million prescriptions in 1991 to more than 245 million prescriptions in 2014. The increase in opioid-related overdose deaths has mirrored the dramatic rise in opioid prescribing, with more than 33,000 deaths in 2015.

 Read the full letter below

Dear Acting Administrator Rosenberg:

 As our nation continues to confront the worsening prescription opioid and heroin epidemic, we write to urge the Drug Enforcement Administration (DEA) to build upon last year’s progress in reducing aggregate production quotas for schedule II opioids and further lower those levels for 2018. 

 In order to effectively combat this raging crisis, stakeholders—especially our federal oversight agencies—must use every tool available to prevent the flood of addictive narcotic painkillers onto the market that can result in misuse, abuse, and diversion.  We have shared our deep concern that, for the past two decades, DEA has approved significant increases in the aggregate volume of opioids allowed to be produced for sale in the United States.  Between 1993 and 2015, DEA allowed aggregate production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.

 As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation.  We were pleased that DEA followed our calls to lower nearly all opioid production quotas by 25 percent or more, including reducing the quota for hydrocodone by 34 percent.  However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic. 

 We have, and will continue to, engage with the U.S. Food and Drug Administration (FDA) on ensuring they are providing your agency with the appropriate information—which takes into account the downstream public health impact of the volume of opioids authorized to come to market—to help inform DEA’s quota-setting process.  In addition, as we have stated to you in the past, we believe that DEA should use existing authorities under the Controlled Substances Act to consider the recent Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain and proactively adjust opioid production quotas, given this “change in the currently accepted medical use” of opioids.

Finally, as DEA issues its draft order for the 2018 production quotas, we urge the agency to foster enhanced transparency and accountability by taking the following actions:

·  Provide an analysis of the approved 2016 opioid production quotas relative to the amount that was ultimately used;

· Provide an explanation for the draft 2018 order of the considerations DEA took into account in establishing the opioid production quotas; and if there is a proposed increase to any opioid production quota, provide a justification of why the public health benefits of increasing the quotas outweigh the consequences of having an increased volume of such substance available for sale and potential diversion in the United States; and

·  Make public the approved individual production quota for each manufacturer of schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, and fentanyl.

We appreciate DEA’s commitment to tackling the opioid epidemic through changes to aggregate production quotas.  By continuing to use its quota-setting authority in a proactive and robust way to combat the opioid crisis, while preserving access for legitimate medical use, DEA has the opportunity to make a real and immediate difference that will benefit American communities and save lives.