Larry P. Cote

DEA Chronicles Blog Feed

http://deachronicles.quarles.com/

DEA Chronicles is our blog dedicated to helping you comply with DEA requirements for controlled substance distribution and prescription dispensing -- and all that comes along with it. The blog is led by Quarles & Brady’s premier DEA Compliance and Litigation Practice Group leader, Larry Cote, a former senior-level DEA attorney, one of the only practicing attorneys with substantial DEA compliance experience to leave DEA’s Office of Chief Counsel in nearly 20 years.

Recent Blog Posts

  • While a great deal of attention is given to DEA Chief Administrative Law Judge Mulrooney’s (“CALJ Mulrooney’s”) opinion regarding the impact of the Ensuring Patient Access and Effective Drug Enforcement Act on DEA enforcement efforts, very little attention has been afforded a shocking and unprecedented attack by a sitting DEA Administrative Law Judge on DEA’s formal administrative hearing process found within the same article. Hidden in plain sight at the end of CALJ Mulrooney’s and Ms. Katherine Legel’s soon-to-be-published law review... More
  • In a recently issued Request for Proposal (RFP) for Information Technology (IT) and other services in support of the Diversion Control Division, DEA indicated that it will be creating a new section in the Code of Federal Regulations. 21 C.F.R. 1301.78, will contain the suspicious order reporting requirement that is currently found in 21 C.F.R. 1301.74(b). DEA intends to define the term “suspicious order” with a list of specific factors to consider when scrutinizing an order. DEA is expected to... More
  • On December 12, 2017, the Senate Judiciary Committee held an oversight hearing to discuss the Ensuring Patient Access and Effective Drug Enforcement Act (the “Act”). The Act has been the subject of recent sensationalized news reports which included interviews with a purported DEA whistleblower and other former DEA employees. In their opening remarks Sens. Grassley and Feinstein  directly contradicted the narrative of the former DEA employees who are critical of the Act and further questioned the lack of complete reporting of... More
  • I am excited to announce that I will be serving as the co-chair of the American Conference Institute’s Summit on Controlled Substances – Regulation, Litigation, and Enforcement.  This is a one-of-a-kind event, bringing together subject matter experts from the pharmaceutical industry and government.  The Summit will address the most pressing topics in controlled substance regulation, litigation and enforcement, including Suspicious Order Monitoring; Abuse-deterrent opioid products; State Prescription Drug Monitoring Programs; State and Federal Enforcement actions against the supply chain; and Policies and Politics of Controlled Substances. Pre... More
  • Dear President Trump, For several years the prescription drug epidemic has ravaged communities across the United States. During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry. Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis. There have been many solutions put forth in the past several months. These solutions, while well-intended, failed to address the root causes of the epidemic – overprescribing... More
  • Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the segment sought to educate viewers on the causes of prescription drug abuse and the alleged slowdown in enforcement efforts by the government, it is of... More
  • The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month.  The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia. In addition to the information generally provided to regulators, the form requires the wholesaler to disclose the reason it classified the... More
  • Federal and state policy makers struggle to come up with solutions to the ongoing opioid crisis. As with many areas of public policy, political leaders are turning to the tax laws as a possible way to curtail opioid abuse. In the past two years, there have been many proposals to impose special or excise taxes on the sale of opioids. To date none have passed. But we believe that without the implementation of other policies to address the issue, a... More
  • On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances. Here are a few takeaways from the Court’s decision: The facts here... More
  • Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017. The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for failing to report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA). The new regulation states: A wholesale distributor must notify the Board in writing of suspicious... More