A recent report by the Government Accountability Office (GAO) found deficiencies in the Drug Enforcement Administration’s (DEA) internal controls intended to ensure that individuals who are granted the authority to handle controlled substances are eligible and remain eligible to handle those substances; In conjunction with the issuance of this report, GAO submitted to DEA the names of over 12,000 individuals with this authority who presented issues that may be associated with a higher risk of illicit activities, including a potential higher risk of drug diversion

In a letter to the DEA, Klobuchar and a bipartisan group of senators called on the agency to provide an update on its efforts to monitor the eligibility of individuals authorized to handle potentially dangerous controlled substances

WASHINGTON, DC – Today, U.S. Senator Amy Klobuchar has requested an update on the Drug Enforcement Administration’s (DEA) efforts to monitor controlled substance providers. A recent report by the Government Accountability Office (GAO) found deficiencies in DEA’s internal controls intended to ensure that individuals who are granted the authority to handle controlled substances are eligible and remain eligible to handle those substances. In conjunction with the issuance of this report, GAO submitted to DEA the names of over 12,000 individuals with this authority who presented issues that may be associated with a higher risk of illicit activities, including a potential higher risk of drug diversion. In a letter to the DEA, Klobuchar and a bipartisan group of senators called on the agency to provide an update on its efforts to monitor the eligibility of individuals authorized to handle potentially dangerous controlled substances.

“As you know, our nation is in the midst of an opioid addiction epidemic. According to the U.S. Centers for Disease Control and Prevention (CDC), the number of deaths attributed to prescription opioid pain relievers and heroin has been trending upward over the last several years, reaching over 30,000 deaths in 2014,” the lawmakers wrote. “The direct correlation between the abuse of prescription opioids and heroin is also a growing concern. The CDC reports that ‘among new heroin users, approximately three out of four report abusing prescription opioids prior to using heroin.’ The DEA’s ability to screen and monitor individuals and businesses licensed to manufacture, handle, and distribute controlled substances is critical to address this epidemic by ensuring that ineligible individuals do not have access to these substances.”

In addition to Klobuchar, the letter was also signed by Senators Tom Carper (D-DE), Ron Johnson (R-WI), Charles Grassley (R-IA), Claire McCaskill (D-MO), and Sheldon Whitehouse (D-RI).

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, was signed into law by the President in July. 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 Senator Joe Manchin (D-WV) 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.

The text of the lawmakers’ letter can be found below.

Dear Acting Administrator Rosenberg:

We write today to request an update on the Drug Enforcement Administration’s (DEA) efforts to reduce risks to ensure that only authorized individuals handle controlled substances in accordance with the Controlled Substances Act. In a recent report, the Government Accountability Office (GAO) found deficiencies in DEA’s internal controls intended to ensure that individuals who are granted the authority to handle controlled substances are eligible and remain eligible to handle those substances.[1] In conjunction with the issuance of this report, GAO submitted to DEA the names of over 12,000 individuals with this authority who presented issues that may be associated with a higher risk of illicit activities, including a potential higher risk of drug diversion.

As you know, our nation is in the midst of an opioid addiction epidemic. According to the U.S. Centers for Disease Control and Prevention (CDC), the number of deaths attributed to prescription opioid pain relievers and heroin has been trending upward over the last several years, reaching over 30,000 deaths in 2014.[2]  The direct correlation between the abuse of prescription opioids and heroin is also a growing concern. The CDC reports that “among new heroin users, approximately three out of four report abusing prescription opioids prior to using heroin.”[3] The DEA’s ability to screen and monitor individuals and businesses licensed to manufacture, handle, and distribute controlled substances is critical to address this epidemic by ensuring that ineligible individuals do not have access to these substances. 

The report issued by GAO was the culmination of more than three years of work examining DEA’s controlled substances database and internal controls for registering and monitoring registrants. After reviewing the DEA’s controls for determining registrant eligibility to handle and prescribe controlled substances, GAO found troubling deficiencies including “limitations in DEA’s controls to help ensure that individual registrants are eligible and remain eligible [to handle controlled substances] and do not present issues that may increase the risk of illicit diversion.”[4]  In particular, GAO identified registrants who were potentially ineligible because they were reported as deceased, did not have state level controlled substance authority, have had their medical licenses revoked, or were incarcerated for felony offenses related to controlled substances. 

To better understand DEA’s efforts in this area and its progress in implementing GAO’s recommendations, we ask that you please respond to the following questions by [two weeks from letter issuance date]:

1.   Please provide a status on the review of the 12,000-plus names submitted to DEA for further review. How is DEA screening these individuals to ensure that they are eligible and remain eligible to handle controlled substances?

2.   GAO recommended that DEA develop a legislative proposal requesting authority to require Social Security numbers for all individuals, regardless of whether they hold an individual or business registration.

a.   Does DEA need new legislative authority to require this information from registrants?

b.   DEA stated it is exploring the possibility and practicality of implementing changes to require Social Security numbers for practitioners. What is the status of these initiatives?

3.   In response to a recommendation that DEA develop policies and procedures to validate Social Security numbers and apply those policies and procedures to all new and existing numbers in the controlled substances database, DEA noted that it initiated discussions with SSA to determine the legality and feasibility of using their Electronic Verification System to verify Social Security numbers provided during the registration process.

a.   What is the status of these discussions? What issues outlined as “critical issues” by DEA in its response to GAO have been resolved? Please provide a detailed description of what issues have been addressed and what issues remain to be addressed.

4.   What actions can DEA take to improve communication with states regarding the status of registrants in its database? Has DEA made a determination regarding its legal authority to access state medical boards’ databases?

5.   What other steps could DEA take to verify the continued eligibility of its registrants? What steps can be taken by the States to make medical licensing and disciplinary action more widely available and accessible to DEA?

6.   During the course of this multi-year engagement, GAO experienced repeated delays in accessing information from DEA, and analysts were often required to perform work on-site. At a Senate Judiciary Committee hearing on June 22, 2016, you committed to cooperating fully with independent auditors and providing them with copies of requested documents and data so that they do not have to waste time and taxpayer dollars performing audit work on-site. What other actions will DEA take to ensure that its oversight bodies, including GAO, are granted full access to information?

As you know, ensuring that the individuals granted the authority to access controlled substances are who they claim to be and are following the rules is a responsibility that is critically important, especially considering the nation’s current opioid addiction epidemic. Thank you for your attention to this inquiry.