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
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
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
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
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
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
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
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
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
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