Tag Archives: Controlled Substances Act

DEA Proposes Changes to Quota Regulations

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 … Continue Reading

DEA Gives Wholesalers Access to Some ARCOS Data, but Not Quantities Purchased

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 … Continue Reading

Are DEA Administrative Hearings Fundamentally Unfair to Registrants?

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 … Continue Reading

Bipartisan Agreement that News Reports Regarding the Ensuring Patient Access and Effective Drug Enforcement Act are Light on Facts

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.… Continue Reading

An “Open Letter” to President Trump Regarding the Prescription Drug Abuse Epidemic

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 … Continue Reading

The Other Side of the Story: DEA Enforcement in the Opioid Crisis

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 … Continue Reading

DEA Reverses Decision to Change Registration Policy

We recently reported that the Drug Enforcement Administration (DEA) was changing its longstanding policy of allowing for a grace period for registrants who file an untimely application for renewal. This notice was posted on the homepage of DEA’s Office of Diversion Control’s website. A Revised Announcement Regarding Renewal Applications is now posted on DEA’s website indicating … Continue Reading

The Continued Evolution of DEA’s Due Diligence Requirements

On May 11, 2016, the Drug Enforcement Administration filed its brief in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (Docket No: 15-1335), in the United States Court of Appeals for the District of Columbia. The vast majority of the Government’s brief addresses whether “substantial evidence” (the applicable standard of review) supports Acting Administrator Rosenberg’s decision … 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

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
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