July 12, 2018
Over the last year, 60 Minutes, in partnership with The Washington Post, has presented several misleading, inaccurate accounts of pharmaceutical distributors’ role in the opioid crisis, including the subsequent enforcement of The Ensuring Patient Access and Effective Drug Enforcement Act. To understand the country’s opioid epidemic and the solutions needed to reduce diversion and misuse of prescription opioids, we need to separate fact from fiction.
For decades, prescription opioids were the recommended course of treatment for millions of Americans suffering from pain. As a result, Centers for Disease Control and Prevention (CDC) data show opioid prescribing in the U.S. peaked in 2010, with healthcare providers writing 81 opioid prescriptions for every 100 patients. Leading public health experts point to this trend as one of the leading drivers of the epidemic today.
The shift in clinical practice around the use of opioids started to change in 2016 when leading public health and medical groups, including the CDC, called for a dramatic change in the way opioids are used to help mitigate the prevalence of overprescribing. While there is still more progress that can be made to stem the prevalence of overprescribing, there is far greater awareness around the need for alternative pain treatments and to engage patients around the safe use of these medicines.
Distributors play a vital role in the healthcare supply chain; however, we do not make, market, prescribe, dispense or in any way have control over which prescriptions are written.
A main tool to prevent abuse of prescription drugs is the prescription itself. Following the updated guidelines released by the CDC, there has been a growing awareness among the medical community and providers about the potential for opioid abuse and misuse. As a result, there has been subsequent changes in pain management and the use of narcotic pain pills.
In 2016, Congress unanimously passed The Ensuring Patient Access and Effective Drug Enforcement Act, marking a dramatic change in information sharing and collaboration among distributors, the Drug Enforcement Administration (DEA) and other stakeholders in the supply chain. The law was designed to improve communication and clarity between the DEA and its registrants (licensed providers, manufacturers, distributors, etc.).
One of the persistent inaccuracies across 60 Minutes’ reporting is the claim that PL 114-145 impeded the DEA’s ability to issue immediate suspension orders (ISOs), pointing to a drop-off beginning in 2011. The reality is that President Obama signed the bill in April 2016 — as such, the law could not have impacted enforcement actions in prior years.
60 Minutes’ false narrative has been discredited numerous times, including by the DEA’s own leadership. For example, after a nearly three-hour hearing before the Senate Judiciary Committee in December 2017, the DEA’s acting administrator, Demetra Ashley, testified that ISOs were one of many tools that the agency had at its disposal, and further, that there was no basis to pursue such an action against a distributor subsequent to the law’s passage.
Under the Controlled Substances Act (CSA), the DEA is able to issue an ISO if there is an imminent danger to public health or safety. However, prior to the passage of the EPAEDEA, there was no federal definition of what constituted “imminent danger.” This lack of formal guidance and transparency did little to serve the best interests of patients, particularly those suffering from cancer, recovering from surgery or facing other serious health issues who had already experienced disruptions to their medicines from misdirected enforcement actions.
In the EPAEDEA, Congress established a definition for “imminent danger” for the first time, a definition that was agreed to by the DEA and Department of Justice (DOJ) as part of the legislative negotiations at the time. Yet, 60 Minutes’ narrative falsely asserts that the DEA was deprived of a critical tool when actually the agency was given clear and transparent guidance.
The law’s authors, including Sen. Orrin Hatch (R-Utah), one of the original co-sponsors of the Senate legislation, has repeatedly reaffirmed that the intent of the bill was to reinforce the DEA’s power to intervene in situations where diversion is suspected. Today, the DEA maintains full authority to take action against a registrant as noted above.
One of the agency’s key regulatory responsibilities includes licensing manufacturers, distributors, pharmacists and doctors who handle controlled substances. In addition, the DEA is the only entity that has a view — via its own ARCOS (Automation of Reports and Consolidated Orders System) database — of the entire prescription opioid supply chain, from manufacturing of the medications to patient delivery. Importantly, the DEA sets the annual production quotas for opioids based on “legitimate medical need” and determines the amount of opioids manufactured each year.
60 Minutes’ misleading reporting relies on the testimony from a former DEA official Joseph Rannazzisi who was responsible for the DEA’s diversion control program and now serves as a consultant to plaintiffs’ lawyers suing the industry. He claims the DEA was powerless in addressing the epidemic, yet 60 Minutes never tells their viewers that the agency had broad authority to regulate the supply and demand of opioids in the market. In fact, Rannazzisi’s office approved the yearly increases to prescription opioids. Between 2004 to 2013, the DEA approved increased production of oxycodone by more than 200 percent. It was only when new leadership took over in 2016 did the DEA unilaterally reduce the overall volume of controlled substances by 25 percent, underscoring the power the agency had maintained all along.
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.