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

  • On April 19, 2018, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM) proposing various changes to DEA’s process for setting Aggregate Production Quotas (APQ) and Individual Procurement Quotas (IPQ). Here are some of the more significant “changes” proposed in the NPRM: Aggregate Production Quotas DEA must consider the diversion of a particular class of drugs when setting APQ; DEA must also consider information from HHS, FDA, CDC, CMA, and state information when setting APQ; DEA must consider diversion as one... More
  • As the national discussion on opioid abuse continues, state governments are looking to their tax laws as a way of “addressing” the issue. The Kentucky House recently approved a 25 cent per pill tax for every dose sent into the state. The measure now moves to the Kentucky Senate. The state expects to raise $70 million a year from the tax. Kentucky does not, however, intend to use the funds for opioid addiction treatment, but plans to use the tax... More
  • The DEA issued a short press release yesterday that, at first glance, appeared to deliver on something that wholesale drug distributors have been seeking for years—access to ARCOS data so that wholesalers can see the total number of controlled substances a customer is ordering.* Despite the sensational headline, the new DEA tool is underwhelming and misses the mark because it will only tell a wholesaler how many other wholesalers a prospective customer has purchased a controlled substance from in the... More
  •           I am pleased to be part of the roundtable panel, “Update on State and Federal Enforcement Initiatives,” at the American Conference Institute’s Summit on Controlled Substances, being held January 29-31 at the Washington Plaza Hotel in Washington, D.C. Conference faculty will discuss current challenges, benchmark strategies, and how to prepare for the future of this critical and fast-paced industry. Hear from: Current and former DEA attorneys Current and former FDA attorneys State and U.S. attorneys In-House Counsel Top law firm counsel Topics include: Reassessing Your Responsibilities in Light of... More
  • 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