Recently, the ranking members of the Judiciary and Finance Committees, Senators Patrick Leahy and Ron Wyden, respectively, raised concerns about Department of Justice (DOJ) oversight of opioid distributors. In a letter sent to Attorney General Loretta Lynch, the senators raised concerns about the “startling decrease in enforcement activity” reported by the Washington Post.
According to the Senators, “by 2020, public and private spending on substance abuse disorder treatment is expected to reach $42.1 billion, compared to $24.3 billion in 2009. Medicare and Medicaid are expected to account for a third of this spending.” The senators noted that they “appreciate and commend the Justice Department for working together with drug manufacturers, distributors, pharmacies, and others, where feasible, to safeguard the supply chain for prescription opioids.” The senators believe that “rigorous enforcement, timely-brought cases, and meaningful penalties are also essential to ensure every part of the pharmaceutical supply chain adheres to the law.”
The senators requested Attorney General Lynch to explain: the drop in enforcement actions sought against large distributors; the standards that the DEA uses to decide whether to pursue enforcement action; DEA settlements with certain distributors; and whether the Ensuring Patient Access and Effective Drug Enforcement Act affected the diversion control division’s ability to seek enforcement actions against distributors.
The Washington Post Report
According to the Washington Post, the DEA began to relax its enforcement efforts after lobbyists hired by Cardinal Health and CVS raised concerns. The number of civil case filings against distributors, manufacturers and doctors dropped from 131 in 2011 to 40 in 2014, even as the opioid epidemic began to worsen. Leahy and Wyden are asking DOJ to explain its policy change, explain its settlement with Cardinal Health and more.
The Washington Post article also notes that the slowdown started when DEA attorneys started requiring higher standards of proof to move enforcement actions forward. Previously, investigators had to show they had a “preponderance of evidence” to pursue enforcement action. But in 2012, Clifford Lee Reeves II, took over the role of supervising enforcement actions under the initiative and started requiring investigators to demonstrate that they had evidence “beyond a reasonable doubt” to pursue action.
According to Barbara Heath, a retired DEA program manager, “It got to the point where they wanted the same evidence as criminal prosecutions. It was very difficult to prove intent.” Jim Geldhof, a retired DEA supervisor, has similar concerns, saying, “There were a lot of roadblocks all the time. Everything was an issue.”
DEA and DOJ Respond
The Senators requested Attorney General Lynch respond to their questions by November 28, 2016.
According to Acting DEA Administrator Chuck Rosenberg, “The pharmaceutical industry has a vital role on the front lines of preventing drug misuse … across [the United States], as do we, and we plan to work closely with them.”
The DOJ has said that the drop in enforcement action taken under the effort reflected a shift from targeting the “ubiquitous pill mills” towards a “small group” of companies, pharmacists, and providers that continue to violate regulations. Peter Carr, spokesperson for the DOJ, also said that investigators are increasingly using criminal procedures over administrative hearings to force violators to surrender their licenses. He also added, “although these reasons largely account for the decline in administrative case filings, the department remains committed to eliminating the problem of opioid [misuse].”
Rosenberg also reminded everyone that the DEA “combat[s] the opioid crisis in many ways: criminally, civilly, administratively, and through robust demand reduction efforts. We implemented new case intake and training procedures for our administrative cases, increased the number of enforcement teams focused on criminal and civil investigations, restarted a successful drug take back program, and improve outreach to – and education efforts with – our registrant community.