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Important Context About the Ensuring Patient Access and Effective Drug Enforcement Act

September 12, 2019

The fundamental premise of recent media coverage — that the passage of the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (EPAEDEA) weakened the Drug Enforcement Administration’s (DEA) enforcement authority during the opioid crisis — is factually incorrect.

Prior to the EPAEDEA, communication between the Drug Enforcement Administration (DEA) and its registrants was extremely limited.

Distributors continuously sought to communicate and coordinate with DEA to better understand our reporting responsibilities under the Controlled Substances Act (CSA), but prior to 2016, these efforts were not reciprocated.

  • The Healthcare Distribution Alliance asked the DEA in 2010, 2011 and 2013 to clarify the companies’ roles and responsibilities, but it received no response. Joe Rannazzisi, the head of DEA's Office of Diversion Control from 2005–2015 affirmed the agency’s lack of guidance about suspicious orders: “It’s DEA’s policy that they do not advise when to ship or when to file a suspicious orders. That’s a business decision that, under the regulations, is maintained by the distributor.”

The Government Accountability Office (GAO) recognized that a lack of communication from DEA to distributors was hampering efforts to effectively combat prescription drug diversion.

  • In its July 2015 report, GAO stated, “The lack of awareness among registrants of DEA resources and conferences suggests that DEA may not have an adequate means of communicating with its registrant populations,” and it concluded, “Without more registrant awareness of DEA resources and adequate guidance and communication from DEA, registrants may not fully understand or meet their CSA roles and responsibilities.”
  • Yet the GAO reported, “Despite the lack of awareness we found that existed among registrants, DEA officials have indicated that they do not believe they need to take any additional steps to improve communication or raise registrants’ awareness of the agency’s conferences and resources.”

The DEA itself acknowledged past shortcomings in effectively communicating with registrants.

  • As then Acting Administrator Chuck Rosenberg told a Senate panel in June 2016, “In many ways, I think we’re broken… we've been slow. I think we've been opaque. I think we haven't responded to them.”

EPAEDEA was a common sense effort to improve coordination between the DEA and its registrants, including distributors.

The legislation simply clarified the definition of “imminent danger” required to issue an immediate suspension order (ISO) where none had previously existed — a definition agreed to by the DEA and Department of Justice (DOJ) before enactment of the law.

  • Under the CSA, the DEA is able to issue an ISO if there is an imminent danger to public health or safety. However, there was no federal definition of what constitutes an “imminent danger.” As a result, the DEA had unfettered ability to immediately suspend a registrant’s ability to handle prescription drugs.

  • Sen. Orrin Hatch, one of the original co-sponsors of the Senate legislation, reaffirmed the intent of the bill was to reinforce the DEA’s power to intervene in situations where diversion is suspected: “It is the intent of the authors that this language authorize the [attorney general] to issue an immediate suspension order in cases where evidence of diversion points to a substantial likelihood of abuse, provided the other conditions for issuing such an order are met.”
The law was crafted, debated and passed with the full involvement of all stakeholders, including the DEA and DOJ.

  • This legislation was passed on a bipartisan basis with open committee hearings and full transparency.

  • Congress would not have unanimously supported the law without the agreement of the DEA and DOJ. At a December 2017 Judiciary Committee hearing, the Acting Assisting Administrator of DEA’s Office of Diversion Control, Demetra Ashley, confirmed that both the DOJ and DEA approved of the final version of the legislation.
Senior DEA officials have repeatedly said that the legislation has not hurt the agency’s ability to bring enforcement actions against distributors if needed. The DEA remains fully empowered to take quick action against a DEA registrant.

Senior officials from the DEA’s Office of Diversion Control have publicly stated that the law has not diminished DEA’s enforcement efforts.

  • Robert Patterson, Acting Administrator, said during a press conference in October 2017: “I don’t think this notion that we slowed down [following the passing of the law] is an accurate one — we’ve used different tools. […] We did not stop doing what we’re supposed to do at DEA.”
  • Neil Doherty, Deputy Assistant Administrator, made the following statement at an Energy and Commerce hearing in October 2017: “The law changed the way that we looked at ISOs. It did not stop DEA from doing its job in the diversion space.” He went on to confirm in an exchange with Representative Welch that the decrease in ISOs occurred before the passage of the law.
  • Ashley stated that there had been no factual basis to pursue an ISO against a distributor subsequent to the law. Ashley’s exchange with Sen. Ted Cruz at the Judiciary Committee hearing is available here.

As the primary regulator of controlled substances, DEA has the responsibility and capability to take action against diversion, yet the agency’s actions often ran counter to those goals.

  • Registrants: The DEA has primary regulatory authority when it comes to licensing the entities who are prescribing, distributing and dispensing controlled substances, including when to suspend or revoke a license. The DEA regularly increased the number of registrants who were prescribing and dispensing controlled substances on a yearly basis.

  • Annual Production Quotas: The DEA sets the annual production quotas for opioids based on “legitimate medical need” and determines the amount of opioids that can be manufactured each year. From 2004 to 2013, the DEA increased production of controlled substances, effectively adding to the supply of opioids on the market. For example, the DEA approved increased production of oxycodone during this time by 39-fold.
  • ARCOS: Pharmaceutical distributors are required to report sales of Schedule II and III opioid-based medications to the DEA’s Automation of Reports and Consolidated Orders System (ARCOS). 
    • ARCOS data was available to be analyzed and could have been used by DEA to proactively identify pharmacies and providers that the regulators believed had suspicious ordering patterns and thus required investigation. 
    • However, a recent report on the agency’s actions in West Virginia at the height of the opioid crisis found that the DEA “did not proactively use ARCOS data to investigate diversion trends.” Further, the report found that distributors were reporting suspicious orders “to local DEA offices that held varying regulatory interpretations, resulting in inconsistent handing of the reports” by DEA.

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The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and 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 nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.


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