DEA Criticized in DOJ-OIG Report for Opioid Quota Management and Diversion Control Measures

The Department of Justice’s Office of Inspector General issued a report last week focused on the Drug Enforcement Administration’s oversight and management of the nation’s prescription opioid quota and slow response to indicia of diversion since 2000. While there was a demonstrated rise in opioid-related overdose deaths since 2000, manufacturing quotas for schedule II and III drugs continued to trend upwards, rising more than 400% between 2002 and 2013. That number has since begun to trend down with stricter prescribing habits and lowered quotas. The report also flags an insufficient vetting and registration process for new DEA registrants, low uptake of e-prescribing for controlled substances, slow production of DEA Diversion Control workplans and lack of enforcement given the agency’s ability to issue Immediate Suspension Orders.

The report makes nine total recommendations for the DEA to better track and combat the diversion of prescription opioids and other controlled substances, including:

  1. Development of a national prescription opioid enforcement strategy;
  2. Required criminal background checks for all new DEA registrants;
  3. E-prescribing for all controlled substance prescriptions;
  4. Require that all suspicious orders be directed to DEA headquarters;
  5. Comprehensive processes for adjudication of DEA registrants;
  6. Allow for greater flexibility in registrant investigations;
  7. Renewal of the drug abuse warning network;
  8. Better facilitate state-federal partnerships to promote data sharing, including state-run PDMPs; and
  9. Consider expansion of the Opioid Fraud and Abuse Detection unit to additional U.S. Attorney offices.

Resources

DOJ Office of the Inspector General – Review of the Drug Enforcement Administration’s Regulatory and Enforcement Efforts to Control the Diversion of Opioids, Evaluation and Inspections Division Report 19-05

POLITICO – DEA Let Opioid Production Rise Amid Mounting Overdose Deaths, Report Finds

New York Times – D.E.A. Let Opioid Production Surge As Crisis Grew, Justice Dept. Says

The Washington Post – DEA Allowed Huge Growth In Painkiller Supply As Overdose Deaths Rose, IG Says


J&J Off Track 1 Bellwether Trial with $20M Settlement

On Tuesday evening, pharmaceutical manufacturer Johnson & Johnson announced that it had reached settlement with Summit and Cuyahoga counties in Ohio to remove themselves from the Track 1 bellwether case in the Northern District of Ohio set to begin later this month. The company will make a $10 million payment to both counties for reimbursement of legal and other expenses with an addition $5.4 million allocated for distribution to non-profit entities in each county to advance opioid-relating programs. As part of the settlement, J&J continues to advocate for a broader global resolution to remedy any of the future cases brought as part of the multidistrict litigation.

Simultaneously, amid appeal of the judgment in the Oklahoma opioid litigation, Johnson & Johnson has now argued that Judge Thad Balkman miscalculated the total by more than $106 million. The appeal indicates that there were three extra zeroes added to the line item focused on information disseminated within the state. J&J claims that number should be $107,000 and not the $107 million indicated in the ruling. Looking to reduce the amount owed as part of the judgment, lawyers for the company would like to see the figure align closer to the settlement reached with Purdue Pharma and Teva prior to the trial.

Resources

J&J Newsroom – Johnson & Johnson Reaches Settlement Agreement with Two Ohio Counties Ahead of Upcoming Opioid Trial

Associated Press – Johnson & Johnson Settles with 2 Ohio Counties Over Opioids

Associated Press – Company Claims Oklahoma Judge Miscalculated Opioid Award


FDA and DEA Jointly Issue Warning Letter Against Online Opioid Drug Seller

In the first example of its kind, the Food and Drug Administration and Drug Enforcement Administration announced last week the issuance of a warning letter to four online networks responsible for the operations and hosting of 10 websites found to be illegally advertising opioids online. Products found on these websites were found to be misbranded, mislabeled and otherwise unapproved for use in the United States. Promotion and sale of these products online is a direct violation of both the Federal Food, Drug and Cosmetic Act as well as the Controlled Substances Act.

On the release of the letter, Acting FDA Commissioner Ned Sharpless said, “As the FDA works to forcefully tackle the opioid crisis on all fronts, we cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health.  Today’s effort is also noteworthy because while the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them. This action further strengthens the warning to the operators of these websites. We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online.”

Articles & Resources

FDA Newsroom – FDA and DEA Warn Website Operators Illegally Selling Opioids

Law360 – FDA, DEA Collaborate On Warnings Over Opioid Sales

Bloomberg – Opioid Internet Sales Spur Novel Joint Warning From FDA, DEA


E&C Republicans to Relaunch Patient Brokering Investigation

Following on a comprehensive investigation launched last Congress, House Energy & Commerce Ranking Member Greg Walden (OR) announced last week the launch of a second phase into the Committee’s work around SUD treatment and recovery fraud and patient brokering. Beyond the two hearings held last Congress, minority staff are now issuing a request for information around various components of the epidemic and access to treatment including challenges, barriers to access and ongoing examples of fraud and abuse. A copy of the RFI is attached with responses requested to Committee staff by November 1st.

Related to treatment access for substance use and opioid use disorders, the Journal of the American Medical Association published a research letter last week looking at disparities in access across urban and rural communities. In looking at five states impacted the significantly by the opioid epidemic – Indiana, Ohio, West Virginia, Kentucky and Virginia – researchers found travel times of approximately 38 minutes. Across the nearly 500 counties surveyed, urban mean drive times to an opioid treatment program was approximately 8 minutes compared to upwards of 50 minutes for rural communities.

Articles & Resources

House Energy & Commerce Minority Newsroom – E&C Republicans Launch New Phase in Patient Brokering Investigation
Journal of the American Medical Association – Drive Times to Opioid Treatment Programs in Urban and Rural Counties in 5 US States


What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Articles & Resources

New York Times – Act Outlawing Drug Houses Doesn’t Apply To Injection Sites, Judge Rules

POLITICO – Judge Rules in Favor of Proposed Philadelphia Safe Injection Site

New York Times – A Doctor Who Prescribed 500,000 Doses Of Opioids Is Sent To Prison For 40 Years

Los Angeles Times – MLB, Players’ Union Mull Opioids Testing; Easing Off on Pot

Wall Street Journal – Three Chinese Nationals Charged With Fentanyl Trafficking

Bloomberg – Genetic Tests for Opioid Abuse Patients Seek Clues to Addiction

Kaiser Health News – States Get New Federal Funding To Expand Medicaid Options To Treat Opioid Addiction

Associated Press – Drug Stores Trying to Remove Judge From US Opioid Litigation

CDC Morbidity and Mortality Weekly Report – National Trends in Hepatitis C Infection by Opioid Use Disorder Status Among Pregnant Women at Delivery Hospitalization — United States, 2000–2015

U.S. Attorney for the Eastern District of Virginia – Dentist Sentenced for Running Prescription Opioid Fraud Scheme

U.S. Attorney for the District of Colorado – Denver Doctor Pleads Guilty To Illegally Prescribing Controlled Substances


Members Remain on Two-Week Recess

The House and Senate remain in-district for a brief two-week recess, set to return to Washington next Tuesday, October 15, following the Columbus Day Holiday. At this time, there are no relevant hearings or events related to opioids on the calendar. Should there be any additions to House or Senate schedules or updates with respect to additional events, this information will be made available.


Questions about the above content can be directed to Matthew.Rubin@FaegreBD.com.