Each year, the Drug Enforcement Administration (DEA) is responsible for setting annual quotas for manufacturers’ production of schedule I and II controlled substances, including opioids; Between 1993 and 2015, the DEA allowed aggregate production quotas for drugs such as oxycodone and hydrocodone to increase dramatically
In a letter to the DEA, Klobuchar joined with other senators to call on the agency to keep addictive painkillers from flooding the U.S. market by setting lower quotas in the coming years
WASHINGTON, DC – U.S. Senator Amy Klobuchar has urged the Drug Enforcement Administration (DEA) to set stricter limits on opioid pills. Each year, the DEA is responsible for setting annual quotas for manufacturers’ production of schedule I and II controlled substances, including opioids. Between 1993 and 2015, the DEA allowed aggregate production quotas for drugs such as oxycodone and hydrocodone to increase dramatically. In a letter to the DEA, Klobuchar joined with other senators to call on the agency to keep addictive painkillers from flooding the U.S. market by setting lower quotas in the coming years.
“We urge the DEA to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic,” the lawmakers wrote. “Fourteen billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills. Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA.”
Klobuchar has long led local and national efforts to curb drug abuse and help people overcome addiction. The Comprehensive Addiction and Recovery Act (CARA), which Klobuchar introduced with a bipartisan group of senators, passed the Senate last week and now heads to the President’s desk to be signed into law. The legislation would encourage states and local communities to pursue a full array of proven strategies in the fight against addiction. To build on the monumental first step of CARA, she also introduced the Prescription Drug Monitoring Act, which would require the use of prescription drug monitoring programs (PDMP) in all states that receive certain federal funding to combat opioid abuse and also requires states to make their PDMP data available to other states. In May, Klobuchar and Manchin introduced the Budgeting for Opioid Addiction Treatment Act (LifeBOAT), which would establish a permanent funding stream to provide and expand access to substance abuse treatment. In September 2014, the Drug Enforcement Administration (DEA) implemented Klobuchar’s bipartisan Secure and Responsible Drug Disposal Act. Under the legislation, consumers are provided with more safe and responsible ways to dispose of unused prescription medications and controlled substances. As Hennepin County Attorney, drug cases accounted for one-third of her office’s total caseload.
In addition to Klobuchar, the letter was also signed by Senators Dick Durbin (D-IL), Sherrod Brown (D-OH), Edward Markey (D-MA), Angus King (I-ME), and Joe Manchin (D-WV). The full text of the letter is below:
Dear Acting Administrator Rosenberg:
Our nation is in the midst of a prescription opioid and heroin crisis that is destroying the lives of our friends, our neighbors, and our family members. In 2014, 28,647 people nationwide died from an opioid overdose. As you stated in announcing the 2016 National Heroin Threat Assessment Summary, “We tend to overuse words such as ‘unprecedented’ and ‘horrific,’ but the death and destruction connected to heroin and opioids is indeed unprecedented and horrific.” We agree and believe efforts to halt this widespread epidemic will not be successful unless we use every tool at our disposal. We urge the Drug Enforcement Administration (DEA) to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic.
We have appreciated hearing about DEA’s efforts to combat the ongoing opioid crisis, including DEA’s “360 Strategy.” While this strategy lists demand reduction as a core focus, it appears primarily focused on the downstream dynamics of the problem, such as targeting the violent cartels and drug trafficking gangs responsible for perpetuating the opioid epidemic. These efforts, much like DEA take-back days, are critically important and should be commended. However, they do not go far enough. We believe DEA can and should be doing more.
Each year, DEA is responsible for setting annual quotas for manufacturers’ production of schedule I and II controlled substances, including opioids. In effect, DEA serves as a gatekeeper for how many opioids are allowed to be legally sold every year in the United States. Yet, 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. According to IMS Health, 14 billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills. Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA.
The Controlled Substances Act provides DEA with a number of authorities, which, if utilized fully, could help appropriately reduce the number of opioids available nationwide. First, when DEA, in a given year, approves a higher opioid quota than is ultimately used, DEA can and should lower the ensuing year’s quota accordingly if there is no other compelling need for the higher quota. Second, DEA has the authority to approve mid-year quota adjustments and thus could take a more judicious approach for initial opioid quota setting and allow for mid-year adjustments, if needed. Finally, when setting quotas, DEA’s authority states that “the Administrator shall consider changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it.” We believe the recent Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain constitutes a “change in the currently accepted medical use” of opioids and should be taken into consideration when setting future years’ opioid quotas.
The 2016 CDC Guidelines recommend dramatic changes in how opioids are prescribed for chronic care patients. For instance, the medical experts at the CDC recommend that patients receive immediate-release opioids instead of extended-release or long-lasting opioids; that patients receive the lowest effective dosage of opioids possible; and that patients receive opioids for the shortest possible effective duration. Taken together, these CDC recommendations clearly demonstrate that fewer opioids will be medically necessary in the coming years.
These new guidelines – coupled with recent opioid drug manufacturer settlements acknowledging both the addiction risks of these products and the insufficient research body about the effectiveness of opioids when used long term – provide grounds within the scope of DEA’s existing authority to take proactive steps to lower quotas.
In addition to the steps outlined above, we also strongly urge DEA to do the following:
- Remove, for schedule II opioids, the 25 percent across-the-board aggregate production quota increase that was implemented in 2013;
- Take into consideration the impact of the opioid manufacturing quotas on the downstream public health burden of opioid misuse and diversion;
- Make public the approved individual manufacturing quota for each manufacturer of schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, and fentanyl;
- In years during which the approved opioid manufacturing quotas increase, provide public justification to explain why the public health benefits of increasing the quotas outweigh the consequences of having an increased volume of such substances available for sale and potential diversion in the United States; and
- Identify formal strategies to improve data collection from approved drug collection receptacles, mail-back programs, and take-back events on the volume and class of controlled substances that are collected and develop a plan to use this information to inform the quota-setting process in subsequent years.
Thank you for your commitment to finding a solution to the prescription opioid and heroin crisis. We look forward to working with you to address this epidemic and request that you outline any authorities DEA needs, but does not currently have, to address the quota-setting concerns and proposed changes outlined above. We appreciate your consideration and look forward to your response.