Senators express concerns that DEA, in coordination with DOJ, scaled back enforcement against violators allowing more legal controlled substances to enter illicit drug market as opioid epidemic exploded

Washington (October 28, 2016) – Senator Edward J. Markey (D-Mass.) and Richard J. Durbin (D-Ill.) were joined by a group of Senators today in sending a letter to the Department of Justice (DOJ) and Drug Enforcement Administration (DEA) querying both agencies about enforcement efforts against wholesale opioid distributors that are violating DEA rules intended to prevent legal controlled substances from entering the illicit market. A recent story in the Washington Post (“The DEA slowed enforcement while the opioid epidemic grew out of control”, October 22, 2016) revealed that, over the last several years, as opioid overdose deaths began to dramatically rise, the DEA was hampered in its enforcement efforts. Several roadblocks, including requiring DEA to use a higher standard of proof before enforcement cases could proceed, and other efforts by the industry to circumvent the agency, led to a drop in civil case filings against distributors, manufacturers, pharmacies, and doctors, from 131 in fiscal year 2011 to just 40 in fiscal year 2014. However, in 2014 alone, U.S. retail pharmacies dispensed 245 million opioid painkiller prescriptions and there were 28,647 opioid overdose deaths.
 
Other Senators signing the letter include Joe Manchin (D-W.V.), Amy Klobuchar (D-Minn.), Tammy Baldwin (D-Wisc.), Bernie Sanders (I-Vt.) and Richard Blumenthal (D-Conn.)
 
“While much of the national attention has focused rightly on opioid painkiller manufacturers like Purdue Pharma, wholesale distributors also play a significant role in the crisis when they place prescription drugs in the hands of corrupt drugstores, pill mills, and crooked physicians,” write the Senators in the letter to U.S. Attorney General Loretta Lynch and DEA Acting Administrator Chuck Rosenberg. “DEA’s Diversion Control Division is charged with disrupting and preventing this flow of pharmaceuticals for illicit purposes while maintaining an adequate supply for legitimate needs.”
 
A copy of the letter to DEA and the Justice Department can be found HERE.
 
In the letter, the Senators ask questions that include:

• Did civil case filings against distributors, manufacturers, pharmacies, and doctors fall between fiscal years 2011 and 2014 and what caused this drop in filings?

• Was DEA policy changed so that DEA lawyers were required to satisfy a higher “beyond a reasonable doubt” standard, as opposed to a “preponderance of the evidence” standard, before civil cases could proceed?

• What is the status of current enforcement actions against distributors?

• What steps are you taking to ensure that DOJ and DEA can proactively and promptly take action against distributors that are violating anti-diversion rules?

• What are the requirements on pharmaceutical manufacturers and distributors for monitoring internal reports, trends, and outliers within its supply chain and reporting this information to the DEA?  

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