WASHINGTON, D.C. – U.S. Sens. John Kennedy (R-La.), Dick Durbin (D-Ill.), Dianne Feinstein (D-Calif.) and Chuck Grassley (R-Iowa), all members of the Senate Judiciary Committee, today introduced the Opioid Quota Reform Act of 2018. This bipartisan legislation will enhance the Drug Enforcement Administration’s (DEA) existing opioid quota-setting authority by improving transparency and enabling the DEA to adjust quotas to prevent opioid diversion and abuse.
The 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. The 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 the 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, more than 14 billion opioid pills 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 the 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.
“Drug overdose deaths have nearly tripled since 1999, and the opioid epidemic costs Louisiana alone about $296 million annually. Addiction is ripping apart families in every town across Louisiana. It’s impacting people in every income bracket and stealing lives,” said Sen. Kennedy. “We have to strike a balance between providing painkillers to people who need them while ensuring that doctors and patients understand how dangerously addictive these drugs are. All it takes is a simple fall from a ladder to create a lifelong battle with painkiller addiction. This is an epidemic that requires a battle plan if it’s going to be defeated.”
“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 Sen. Durbin. “The DEA plays an important gatekeeper role over the volume of opioids that can be produced each year. And while the DEA has taken recent steps to lower opioid quotas, their ability to do so is limited. Opioid quota reform is needed so the 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 the 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.”
“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 Sen. 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,” Sen. 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 — the DEA heeded calls to address America’s opioid epidemic by reducing nearly all opioid quotas by 25% or more. This was the first reduction of its kind in over 20 years. And in November 2017, the DEA again reduced production quotas for nearly all Schedule II prescription opioids by 20% 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, the reduction resulted in a 31% cut to oxycodone over two years; a 43% cut to hydrocodone over two years; and a 42% cut to fentanyl over two years. But more work must be done to rein in this epidemic, and the DEA needs more statutory tools to effectively do its job.
The bipartisan Durbin-Kennedy Opioid Quota Reform Act of 2018 would:
- Direct the 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 the 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 the DEA report anonymized data to Congress on the number of manufacturers that the DEA authorizes to produce opioids each year and how many of those manufacturers’ quotas have increased from the previous year;
- Enable the DEA to issue more granular quota levels by removing a current provision that blocks the DEA from considering variations in dosage forms when setting quotas; and
- Require the 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.