Durbin. Kennedy, Feinstein, Grassley Introduce Opioid Quota Reform Bill To Strengthen DEA's Ability To Prevent Opioid Diversion And Abuse

Bipartisan legislation would improve transparency and provide more tools to enhance DEA’s existing opioid quota-setting authority

WASHINGTON – In the midst of a prescription opioid, heroin, and fentanyl crisis that is devastating communities of all sizes in every state, U.S. Senators Dick Durbin (D-IL), John Kennedy (R-LA), Dianne Feinstein (D-CA), and Chuck Grassley (R-IA), all members of the Senate Judiciary Committee, today introduced the Opioid Quota Reform Act of 2018.  This narrow, bipartisan legislation will enhance the Drug Enforcement Administration’s (DEA) existing opioid quota-setting authority by improving transparency and enabling DEA to adjust quotas to prevent opioid diversion and abuse.

DEA is responsible for establishing annual quotas determining the exact amount of each opioid drug that is permitted to be produced in the U.S. each year.  DEA approved significant increases in aggregate opioid production quotas between 1993 and 2015, including a 39-fold increase for oxycodone and a 12-fold increase for hydrocodone.  Such increases occurred largely because current law directs DEA to only consider certain factors when setting quotas—like past sales and estimated demand—but not other factors such as the impact of such opioid production on diversion, abuse rates, or overdose deaths.  As a result, 14 billion opioid doses are put on the market each year—far more than necessary under current medical guidelines and enough for every adult American to have a one month’s prescription of addictive painkillers. 

Recognizing this problem, Attorney General Jeff Sessions has asked DEA to evaluate whether changes are needed to its production quota process to address the disproportionate volume of opioid prescriptions issued each year in the United States.  

“Every day, more than 100 Americans die from an opioid overdose.  While we know that there are legitimate uses for opioid painkillers, we also know that these dangerous pills are being over-produced, over-prescribed, and over-dispensed,” said Durbin.  “DEA plays an important gatekeeper role over the volume of opioids that can be produced each year.  And while DEA has taken recent steps to lower opioid quotas, their ability to do so is limited.  Opioid quota reform is needed so DEA can take important factors like diversion and abuse into account when setting quotas, rather than chasing the downstream consequences of this crisis.  And this bipartisan legislation will allow DEA to do just that.  But our work is not done.  These quotas should continue to come down, doctors must be more judicious in their prescribing, drug companies must stop misleading the public about their products, and we simply must do more to help those who are currently addicted get treatment.”

“Drug overdose deaths have nearly tripled since 1999, and the opioid epidemic costs Louisiana alone about $296 million annually.  This is unacceptable,” said Kennedy.   “If even one of these prescription opioid related overdoses can be prevented by our bill, we are one step closer towards winning the war on drugs.”

“We have a responsibility to better address the opioid epidemic, which took the lives of more than 42,000 Americans in 2016, by stopping addiction before it starts,” said Feinstein.  “I believe this bill strikes the right balance in maintaining access to medications for legitimate medical use and reducing the supply of opioids available to be diverted and abused. I am confident that this bill can help reduce the astonishing number of drug overdose deaths in our country, and am pleased to be a cosponsor.” 

“The opioid crisis will only be beat back if we use every tool possible to fight against it. This legislation is one of those tools,” Grassley said.  “Improving transparency in setting opioid quotas is critical to curbing opioid abuse while ensuring those who need opioids to treat illnesses and manage pain will still have lawful access to their medicine.  As Chairman of Judiciary Committee and the Narcotics Control Caucus, I care deeply about finding a solution to the opioid epidemic, and this legislation is a step in the right direction.”

In 2016—after years of dramatic increases to the volume of opioids allowed to come to the market—DEA heeded calls led by Senator Durbin to address America’s opioid epidemic by reducing nearly all opioid quotas by 25 percent or more.  This was the first reduction of its kind in over twenty years.  And in November 2017, DEA again reduced production quotas for nearly all Schedule II prescription opioids by 20 percent for 2018.  This meant that three powerful, addictive painkillers would see a significant reduction from what was allowed on the market just two years prior: for example, a 31 percent cut to oxycodone over two years; a 43 percent cut to hydrocodone over two years; and a 42 percent cut to fentanyl over two years.  But more work must be done to rein in this epidemic, and DEA needs more statutory tools to effectively do its job.   

The bipartisan Durbin-Kennedy Opioid Quota Reform Act of 2018 would:

  • Direct DEA to consider the additional factors of opioid diversion, abuse, overdose deaths, and public health impacts when establishing annual opioid production quotas, in addition to the existing statutory considerations such as prior-year sales and research needs; 
  • Require DEA, if it approves any annual increase in opioid quotas, to explain publicly why the public health benefits of the increase outweigh the potential harmful consequences;
  • Reveal trends in manufacturer-level quota increases by having DEA report anonymized data to Congress on the number of manufacturers that DEA authorizes to produce opioids each year and how many of those manufacturers’ quotas have increased from the previous year;
  • Enable DEA to issue more granular quota levels by removing a current provision that blocks DEA from considering variations in dosage forms when setting quotas; and 
  • Require DEA to identify strategies to better incorporate data collection and changes in accepted medical practice (such as updated CDC Opioid Prescriber Guidelines) in its quota-setting process. 

The Opioid Quota Reform Act of 2018 is supported by the National Association of City and County Health Officials, National Association of Counties, Trust for America’s Health, Safe States Alliance, and National Safety Council.