Durbin, Senators Request Update On Drug Enforcement Law
Durbin, Brown, Markey Led Letter To HHS, DEA Following Washington Post, "60 Minutes" Opioid Investigation
WASHINGTON—U.S. Senators Dick Durbin (D-IL), Sherrod Brown (D-OH), and Ed Markey (D-MA) led a letter to the U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) requesting information on the impact of the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 highlighted in a recent report from The Washington Post and “60 Minutes.” The letter also calls upon the agencies to submit a long-overdue report to Congress providing both an overview of current steps being taken to tackle this epidemic, as well as recommendations to further prevent opioid over-prescribing and enhance public reporting. The Senators are working with the agencies to ensure they have the tools they need to fight the opioid addiction epidemic.
“As members of Congress from states severely affected by the nation’s addiction epidemic, we are concerned by these recent news reports and the issues they raise, and we write to request that you immediately provide Congress with an update on the law’s impact on the war against addiction,” wrote the Senators in the letter. “It is critical that we have all the information necessary to ensure the federal government is doing everything it can to help support our states and local communities in our collective fight against this epidemic.”
Current law requires the HHS Secretary to submit a report to Congress identifying strategies to prevent diversion and abuse of controlled substances, including providing recommendations for improved education for opioid prescribers and enhanced data transparency and use of prescription drug monitoring programs. This report is more than six months past-due and the Senators want HHS and the DEA to provide the information immediately, so they can determine the best action to take to ensure the DEA has the tools it needs to fight the opioid epidemic.
The letter was also signed by U.S. Senators Patrick J. Leahy (D-VT), Ron Wyden (D-OR), Jack Reed (D-RI), Tom Carper (D-DE), Debbie Stabenow (D-MI), Bob Casey (D-PA), Bernie Sanders (I-VT), Amy Klobuchar (D-MN), Sheldon Whitehouse (D-RI), Jon Tester (D-MT), Tom Udall (D-NM), Jeanne Shaheen (D-NH), Mark Warner (D-VA), Michael Bennet (D-CO), Kirsten Gillibrand (D-NY), Al Franken (D-MN), Joe Manchin (D-WV) Chris A. Coons (D-DE), Richard Blumenthal (D-CT), Brian Schatz (D-HI), Tammy Baldwin (D-WI), Angus King (I-ME), Tim Kaine (D-VA), Elizabeth Warren (D-MA), Heidi Heitkamp (D-ND), Cory Booker (D-NJ), Gary C. Peters (D-MI), Chris Van Hollen (D-MD), Maggie Hassan (D-NH), and Kamala D. Harris (D-CA).
Last week, Durbin joined Senator Claire McCaskill (D-MO) to co-sponsor legislation that would overturn two key provisions of the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 that have made it more difficult for DEA to intervene in situations involving suspicious activity. According to former DEA officials cited in The Washington Post report, the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 changed the evidentiary threshold that the DEA needed to meet to a harder standard when seeking to suspend drug companies’ registration. It also created a mechanism for the pharmaceutical industry and distributors to submit a corrective action plan instead of being subject to a suspension order, if their activities were contributing to the diversion of drugs. The McCaskill bill would preserve a provision in the 2016 law requiring the HHS Secretary to issue the report to Congress described above.
Full text of the letter is available here and below.
Acting Secretary Eric Hargan
United States Department of Health and Human Services
200 Independence Ave, SW
Washington, DC 20201
Acting Administrator Robert Patterson
United States Drug Enforcement Administration
8701 Morrissette Dr.
Springfield, VA 22152
Dear Acting Secretary Hargan and Acting Administrator Patterson:
This weekend’s Washington Post article entitled “The Drug Industry’s Triumph Over the DEA” and CBS’s related 60 Minutes expose on the opioid epidemic have raised significant questions regarding the impact of the Ensuring Patient Access and Effective Drug Enforcement Act (P.L. 114-145), which was signed into law in April of 2016. As members of Congress from states severely affected by the nation’s addiction epidemic, we are concerned by these recent news reports and the issues they raise, and we write to request that you immediately provide Congress with an update on the law’s impact on the war against addiction.
In light of these reports and as Congress evaluates this law taking into account the nation’s addiction epidemic, it is critical that we have all the information necessary to ensure the federal government is doing everything it can to help support our states and local communities in our collective fight against this epidemic. We want to ensure the Drug Enforcement Administration (DEA) and other related agencies have all of the tools necessary to fight this epidemic, which is why we also request that the Department of Health and Human Services (HHS), in coordination with DEA, immediately provide Congress with a status update on the Report to Congress required under Section 3 of the law.
As you are aware, Section 3 of P.L. 114-145 requires the Secretary of HHS, in coordination with the DEA Administrator and in consultation with other relevant executive offices, to submit a report to Congress identifying any residual issues with diversion of controlled substances. The law also requires the Administration’s Report to Congress to include a section detailing “how collaboration between Federal, State, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances,” as well as a section with suggested “steps to improve reporting requirements so that the public and Congress have more information regarding prescription opioids.”
This report was due to Congress on April 16, 2017. As of October 16, 2017 – exactly 6 months past the deadline for this information – no such report has been submitted to the relevant congressional committees. As Congress revisits the Ensuring Patient Access and Effective Drug Enforcement Act and considers whether the DEA has all of the tools it needs to play an effective role in combatting this public health emergency, it is critical that we have the information necessary to evaluate this law.
We urge HHS to act swiftly to provide the relevant committees with an update on the impact of P.L. 114-145 and a report on any challenges in diversion control that may have been exacerbated by the law’s passage by no later than October 30, 2017, as well as a complete Report to Congress as laid out in Section 3 of the law, as soon as possible.
Sincerely,