Category Archives: Enforcement Actions

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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

DEA Decisions: Clarifying a Respondent’s Right to the Presentation of Remedial Evidence and Discovery

On February 18, 2015, the DEA issued its final decision and order in the case against prescriber Hatem M. Ataya (“Ataya”). The Administrator ordered Ataya’s registration to be revoked and his pending applications for additional registrations to be denied on the grounds that Ataya has, since the proceedings began, lost the authority to dispense controlled … Continue Reading

DEA Decisions: Community Impact Factor Still Relevant to Pharmacy Registrations

On November 13, 2015, the DEA issued its final decision and order in the case against Perry County Food & Drug (“PCFD”). The Administrator denied PCFD’s pending application to renew its registration based on stipulations by PCFD that its pharmacist-in-charge, who happened to be the son of PCFD’s owner, created and filled fraudulent prescriptions and … Continue Reading

DEA Administrator Overrules ALJ, Revokes Distributor Registration in Sweeping Decision

The Chronicles welcomes guest blogger Katea Ravega, a Q&B Health Law attorney. In a 308-page decision dated September 8, 2015, the new Acting Administrator of the DEA, Chuck Rosenberg, issued an Order revoking the DEA registration of wholesale distributor Masters Pharmaceuticals, Inc. (“Masters”). In doing so, the Administrator rejected the recommendation from DEA’s own Administrative … 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 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

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

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 Decisions: In the Matter of The Medicine Shoppe

In the Matter of the Medicine Shoppe (October 2, 2014) DEA recently revoked the registration of the Medicine Shoppe, a San Antonio, Texas,  pharmacy, based on a finding that the pharmacy violated the Controlled Substances Act in all of the following ways: dispensed controlled substances without a prescription; dispensed controlled substances when the prescription was “signed” … Continue Reading

FedEx Pleads Not Guilty

As expected, FedEx appeared in federal district court and entered a plea of not guilty to the charges brought against the company by the Drug Enforcement Administration (“DEA”) and the United States Attorney’s Office for the Northern District of California.  As we have recently discussed, this is an unprecedented action by the government seeking to … 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

Non-Suspicious is Suspicious: DEA Moved the Goal Post Again!

Just when you thought it was safe to have a robust order monitoring program to detect and report suspicious orders, DEA has moved the goal post.  In previous posts (here and here), we’ve talked about DEA’s “extra-regulatory” guidance on both suspicious orders and “due diligence”.  In late February-early March, the DEA held a hearing in … Continue Reading

DEA Must Obtain a Warrant to Access PDMP Data in Oregon

Federal Court Rules Patients Have Reasonable Expectation to Privacy of Prescription Drug Information A Federal District Court in Oregon has ruled that patients have a Fourth Amendment privacy right in their prescription drug information–even if such information is forwarded to and maintained by a state-run database.  Consequently, government agencies will be required to obtain a … Continue Reading

Upcoming Conference: Controlled Substances Forum

If you’re looking for fast-track training, I am co-chairing a conference that you may be interested in: American Conference Institute’s Legal, Regulatory & Compliance Forum on Controlled Substances.  The conference is in DC on January 16-17 and will provide training in core regulatory concepts dealing with DEA-scheduled pharmaceutical products. Additional details below. To view the agenda … Continue Reading

DEA and Walgreens Settlement

On June 11, 2013, the DEA announced that Walgreens Corporation agreed to pay $80 million in civil penalties, the largest settlement in DEA history.  This settlement resolves both the DEA’s administrative actions against Walgreens and the U.S. Attorney’s Office’s civil penalty investigation.  In addition to the civil penalty, Walgreens agreed to a two year suspension … Continue Reading

Upcoming DEA Conferences

The DEA has announced an upcoming Manufacturer/Importer/Exporter Conference to be held in June 2013 at the National Harbor, Gaylord National Resort & Convention Center. “The purpose of this conference is to provide a forum to present federal laws and regulations that affect the pharmaceutical and chemical manufacturing, importing, and exporting industry and to discuss practices … Continue Reading

Legitimate Pain Clinics?

DEA is okay with some pain management clinics. A DEA official told an industry conference that some pain management clinics are legitimate.  When describing the proliferation of pain management clinics, DEA Associate Deputy Administrator Alan Santos told the audience at HDMA’s Distribution Management Conference and Technology Expo that prior to the rapid growth of pain … Continue Reading

Oral Argument: Walgreen Co. v. DEA

Today the Court of Appeals for the District of Columbia Circuit heard oral arguments in the matter of  Walgreen Co. v. Drug Enforcement Administration, et al., (Docket No. 12-1397).  I will leave the prognosticating to trained professionals; however, it was clear to me that Walgreens was before a sympathetic panel. The three-judge panel asked several … Continue Reading

2012 DEA Enforcement Actions: A Year in Review

While the Drug Enforcement Administration (“DEA”) prosecuted far fewer administrative actions in FY2012 than FY2011, the Agency nonetheless continued to be very active in investigating pharmaceutical diversion cases. The highly publicized and unprecedented actions taken by DEA in FY2012 provide valuable insight to where the DEA may focus its enforcement efforts in 2013. The “DEA Year in Review” is … Continue Reading
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