Larry P. Cote

Firm/Organization: Cote Law PLLC

Latest Articles

Problems Identified, Solutions Proposed: the OIG Review of DEA

By Larry P. Cote & Russell Day on October 4, 2019

Is “Suspicious Order” about to be defined? The recently-released DOJ OIG Review of the Drug Enforcement Administration’s Regulatory and Enforcement Efforts to Control the Diversion of Opioids has met with extensive media coverage focused on the sexier aspects of the story. What did DEA do or not do to stem the opioids crisis? What internal battles may have led DEA to drop the ball in some aspects of the response? These are important…

DEA Chronicles

FDA Approves New Packaging for “Poor Man’s Methadone”

By Larry P. Cote & Russell Day on September 22, 2019

While acknowledging the safety of the approved daily doses of OTC loperamide for adults (8mg per day) and prescription loperamide (16mg per day), the FDA recently approved new package-size and package-type limits for the brand-name OTC tablet and capsule forms of the drug. Here are the products affected by the FDA’s notice: Imodium A-D Imodium Multi-Symptom Relief Be Health Loperamide HCl Capsules Loperamide has been referred to as the “poor man’s methadone,” due to…

DEA Chronicles

DEA Proposes Decreasing Opioid Quotas for 2020

By Larry P. Cote & Russell Day on September 11, 2019

Quota Reductions DEA is out with its proposed 2020 aggregate production quotas for Schedule I and II controlled substances, and they have been reduced dramatically from 2019’s numbers. From the press release: DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in…

DEA Chronicles

DEA Decisions: Registrations Not Automatically Revoked by Medicare/Medicaid Exclusions

By Larry P. Cote & Russell Day on September 6, 2019

Jeffrey Stein, M.D.; Decision and Order Uttam Dhillon, DEA Acting Administrator, issued a final order today in the case of the revocation of a New York doctor’s DEA registration. But its implications go well beyond this doctor’s circumstances. The Facts Here are the basics. Dr. Jeffrey Stein was convicted of tax-related crimes in the Southern District of New York in 2015. Specifically, Dr. Stein had provided false receipts and other fabricated documents to his accountant…

DEA Chronicles

DEA and the Surgeon General Issue Statements Regarding Marijuana

By Larry P. Cote on September 2, 2019

Last week was an active week when it comes to marijuana policy. The Drug Enforcement Administration (DEA) announced that it will begin considering (and approving?) applications to allow for the manufacture (growing) of marijuana for research purposes. Shortly thereafter, United States Surgeon General, Vice Admiral Jerome M. Adams (Dr. Adams), issued an advisory regarding the significant adverse effects of marijuana use by adolescents and by women during pregnancy. Both developments could foreshadow the long road…

DEA Chronicles

Be Part of the Solution to the Opioid Crisis – Make the Pledge!

By Larry P. Cote on August 27, 2019

Just as there are several factors that contributed to the opioid epidemic, there are a myriad of solutions that, in tandem, will make a difference in the lives of those impacted by opioid abuse and may prevent others from misusing and abusing these drugs. Roger Krone and his team at Leidos are executing a program that should be emulated by companies across the United States. After receiving an email from an employee whose son recently lost …

DEA Chronicles

FDA Issues Another Warning Letter Involving CBD Products

By Larry P. Cote on July 24, 2019

On July 23, 2019, the Food and Drug Administration (FDA) announced the issuance of a Warning Letter to the manufacturer of certain products containing cannabidiol (CBD). Specifically, the FDA provided a laundry list of examples where Curaleaf, Inc. (Curaleaf) made unsubstantiated claims on its website and on social media “that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.” The FDA considers Curaleaf’s actions as the…

DEA Chronicles

Does the New Rule on Interlocutory Appeals Undermine the Independence of DEA’s ALJs?

By Larry P. Cote on April 29, 2019

As I have previously written, there is a long list of regulatory changes coming from DEA in the next few years. Rather than publish one or more of the long overdue regulations listed on DEA’s Regulatory Agenda, on April 30, 2019, the agency will publish a Final Rule creating a “discretionary review” process allowing the Administrator to review an Administrative Law Judge’s (“ALJ’s”) denial of a request for an interlocutory appeal. Note that this…

DEA Chronicles

Key Takeaways from the Rochester Drug Co-Op Deferred Prosecution Agreement

By Larry P. Cote on April 24, 2019

As you undoubtedly should know by now, on April 22, 2019, the United States Attorney for the Southern District of New York entered into a Deferred Prosecution Agreement (the “Agreement”) with the Rochester Drug Co-operative, Inc. (“RDC”). Specifically, the government announced that “RDC agreed to accept responsibility for its conduct by making admissions and stipulating to the accuracy of an extensive Statement of Facts, pay a $20 million penalty, reform and enhance its Controlled…

DEA Chronicles

Breaking News: DEA Provides Additional Access to ARCOS Data

By Larry P. Cote on February 26, 2019

As required by the “SUPPORT for Patients and Communities Act” (Public Law 115-217), DEA just announced that it has implemented a new tool to provide drug manufacturers and distributors with access to anonymized ARCOS information. This an enhancement to DEA’s existing tool that previously provided very limited ARCOS information. The new functionality in the tool “will allow DEA-registered manufacturers and distributors to view and download the number of distributors and the amount (anonymized data in…

Larry P. Cote

Problems Identified, Solutions Proposed: the OIG Review of DEA

FDA Approves New Packaging for “Poor Man’s Methadone”

DEA Proposes Decreasing Opioid Quotas for 2020

DEA Decisions: Registrations Not Automatically Revoked by Medicare/Medicaid Exclusions

DEA and the Surgeon General Issue Statements Regarding Marijuana

Be Part of the Solution to the Opioid Crisis – Make the Pledge!

FDA Issues Another Warning Letter Involving CBD Products

Does the New Rule on Interlocutory Appeals Undermine the Independence of DEA’s ALJs?

Key Takeaways from the Rochester Drug Co-Op Deferred Prosecution Agreement

Breaking News: DEA Provides Additional Access to ARCOS Data

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