Category Archives: Drug Policy

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Oregon Adds Suspicious Order Reporting to Wholesale Distributor Requirements

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 … Continue Reading

DEA Decisions: In the Matter of Wesley Pope, M.D.

An Oklahoma doctor wrote 19 Schedule II controlled substance prescriptions for a patient with low back pain over eight months without thoroughly documenting the patient’s history, confronting the patient over aberrant drug tests, or talking to other doctors who were prescribing the patient controlled substances. The Chief Administrative Law Judge felt the doctor should be … Continue Reading

Surgeon General Seeks Support from Doctors to End Opioid Epidemic

Last week, the U.S. Surgeon General, Dr. Vivek H. Murthy, sent a letter to 2.3 million American health professionals asking them to lead a national movement to “turn the tide” on the nation’s prescription opioid epidemic.  After visiting communities hardest hit by the opioid epidemic, Dr. Murthy’s appeal to clinicians was personal:   “Everywhere I … Continue Reading

DEA Will Not Reschedule Marijuana

  Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research. … Continue Reading

Improving Regulatory Transparency for New Medical Therapies Act Heading to the President as Amended by the Senate

On November 16, 2015, the House of Representatives agreed to the Senate’s amended version of the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639). We previously described how the version of H.R. 639 originally passed by the House gave manufacturers clarity and security on the timing of DEA actions related to the entrance of … Continue Reading

DEA Releases 2015 National Drug Threat Assessment Summary

On November 4, 2015, DEA Acting Administrator Chuck Rosenberg announced the results of the 2015 National Drug Threat Assessment Summary (NDTA). In addition to reporting in-depth findings regarding the availability and use of nine drugs of abuse, the 2015 NDTA focuses on the increasing threat of transnational criminal organizations (“TCOs”), confirming Michelle Leonhart’s testimony before … Continue Reading

Amendment to CSA Closer to Becoming Law

DEA Chronicles welcomes guest blogger Julia Hudson, a Q&B Health Law attorney. On September 30, 2015, the Improving Regulatory Transparency for New Medical Therapies Act moved one step closer to becoming federal law by passing the Senate Health, Education, Labor and Pensions Committee.  The bill, which was introduced on February 2, 2015 and passed in the House on … Continue Reading

GAO Issues Another Report Involving DEA

On July 27, 2015, the Government Accountability Office (GAO) released a report titled, Prescription Drugs: More DEA Information about Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access.  GAO’s report examined, (1) to what extent registrants interact with DEA about their CSA responsibilities, and registrants’ perspectives on those interactions, (2) how state … Continue Reading

DEA to Continue Take Back Programs

On September 23, 2014, DEA announced that its ninth Take Back Day would be the agency’s last.  The announcement was made shortly after DEA published the Final Rule implementing the Secure and Responsible Drug Disposal Act of 2010.  The regulations promulgated by DEA allow “authorized collectors” the opportunity to receive and securely dispose of prescription … Continue Reading

Rising Heroin Use Linked to Rx Opiate Abuse

The Chronicles welcomes guest blogger Jazzmin Lewis, a summer associate in Q&B’s Indianapolis office. Jazzmin is entering her final year at Indiana University-Maurer School of Law. Last week the Center for Disease Control and Prevention (CDC) released its Morbidity and Mortality Weekly Report regarding the recent increase in heroin use in the United States. The report … Continue Reading

DEA Announces Major Enforcement Action

On May 20, 2015, DEA issued a press release regarding a recent major enforcement action in Arkansas, Alabama, Louisiana, and Mississippi. Operation Pilluted targeted alleged pill mills that were engaged in the illegal distribution of oxycodone, hydrocodone and Xanax. The operation resulted in the arrest of 280 individuals, including 22 doctors and pharmacists. Executing 21 search … Continue Reading

Senate Committee Questions DEA on Quota Process

On May 5, 2015, the United States Senate, Caucus on International Narcotics Control held a hearing exploring the findings and recommendations of a Government Accountability Office investigation into the Drug Enforcement Administration’s management of its quota process.  The hearing, called by Senators Grassley and Feinstein, sought to explore the connection between DEA’s quota process and … Continue Reading

Rx Denied: A Prescription for Misery

  WESH TV of Orlando aired a special investigative report on April 2, 2015 detailing the unintended consequence of the crackdown on “pill mills” in Florida.  State of Pain reveals that some patients with severe medical conditions are having difficulty finding pharmacies willing to fill their prescriptions for controlled substances.  The causes for this are many and include pharmacists’ fear … Continue Reading

GAO Report Criticizes DEA Quota Process

On March 4, 2015, the Government Accountability Office (GAO) released a report titled, Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved.  GAO’s report examined, (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA’s administration of the quota … Continue Reading

Second Bill Introduced in the Senate to Amend the Controlled Substances Act

As we previously reported, on February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.  Also on that date, the Senators introduced legislation that would also amend the Controlled Substances Act, as well as the Food, Drug, and Cosmetic Act.  This legislation addresses, among other things, … Continue Reading

Legislation Introduced in Senate Seeking to Amend CSA

On February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.  This is the companion bill to H.R. 471, sponsored by Representatives Marino, Blackburn, Welch, and Chu that was recently approved by the Subcommittee on Health, Energy and Commerce Committee. At a recent Congressional hearing, Linden … Continue Reading

DEA Announces New Ways for the Public to Dispose of Unused Controlled Substances

Beginning next month, consumers will have an easier time getting rid of unused painkillers and other addictive drugs, which DEA hopes will discourage people from flushing the drugs down the toilet, throwing them in the garage, or leaving them, forgotten, in their medicine cabinets.  The new disposal methods include allowing people to drop off unwanted … Continue Reading

Don’t Squeeze the Balloon: An International Perspective on Preventing Prescription Drug Overdoses

Last year the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) published a paper on reducing opioid overdose mortality.  The paper addressed opioid overdoses related to heroin use and concluded that reduction in supply is an effective measure governments can take to reduce heroin overdoses.  The UNODC and WHO … Continue Reading

Defining, but Protecting, DEA’s Suspension Powers: the Impact of HR 4069

The “Ensuring Patient Access and Effective Drug Enforcement Act” introduced by Representatives Blackburn and Marino defines the term “imminent danger.”  The Controlled Substances Act requires DEA to find that a registrant poses an imminent danger to public health or safety before the Agency can issue an immediate suspension order, but the current law does not define … Continue Reading

Congressional Hearing on CSA Amendment

Today at 3 p.m., I will be joining DEA’s Mr. Joseph Rannazzisi, HDMA CEO John Gray and others to testify before the House Energy and Commerce Subcommittee on Health regarding a proposed amendment to the Controlled Substances Act.  H.R. 4069, introduced by Representative Tom Marino of Pennsylvania and Representative Marsha Blackburn of Tennessee, defines two key … Continue Reading

Sometimes Numbers Lie: Decline in Opioid Prescriptions is Hollow

According to the Milwaukee Journal Sentinel, IMS has reported that the number of prescriptions for opioids declined 5% in 2013 compared to 2012.  Although this could signal a positive step in combating opioid abuse, data suggest otherwise.  The decline in the number of prescriptions for opioids signals one thing only — a decline in the number of prescriptions.  … Continue Reading

Hydrocodone Rescheduling: Yesterday’s Solutions for Today’s Problem

FDA recently announced that it was recommending that hydrocodone combination products be moved from Schedule III to Schedule II under the Controlled Substances Act.  The placement of hydrocodone combination products in Schedule II is a great idea — for 2003.  But FDA’s belated action is unlikely to have a significant impact on prescription drug abuse. … Continue Reading

DEA Holds Drug Take-Back Event

On October 26, 2013, DEA will hold its seventh National Prescription Drug Take Back Day at locations throughout the United States.  As we previously discussed, 69% of individuals misusing prescription drugs obtain the drugs from a family member or a friend.  This is a great opportunity to get rid of expired, unused or unwanted prescription drugs … Continue Reading
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