On Monday, Japanese drug maker Eisai Inc. filed a lawsuit against the DEA in the District of Columbia Court of Appeals. Their complaint? Eisai created a drug, called Fycompa, that the FDA approved last October to treat epileptic seizures. Due to FDA’s scheduling recommendation and the drug’s effect on the central nervous system, the DEA
DEA Decisions: In the Matter of Tyson D. Quy
Editor’s note: This post is the first in our new “DEA Decisions” series where we will provide summaries of Final Orders issued by the DEA on administrative matters litigated before the agency. We hope they are helpful to you — let us know! In the Matter of Tyson D. Quy, M.D., 78 Fed.
A Pharmacist’s Obligation: Corresponding Responsibility and Red Flags of Diversion
Corresponding responsibility is perhaps one of the most commonly misunderstood and/or (unfortunately) unknown concepts found in DEA’s regulations. And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility. I have had countless conversations with practicing pharmacists who are either unfamiliar with the concept of a “corresponding responsibility” or don’t understand how to apply it in their daily practice. The DEA’s regulations (21 C.F.R. § 1306.04) addressing corresponding responsibility state A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
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
Obtaining DEA Quota to Manufacture Controlled Substances
DEA Quota Season is Upon Us This is the first of several discussions we will have regarding the DEA quota process and the adverse impact DEA’s handling of the quota process can have on the availability of controlled substances for the legitimate medical needs of the United States. Some context and background is required to
DEA’s Uneasy Relationship with Oxycodone
DEA’s position on oxycodone is clear — more or less. In DEA’s letter to FDA supporting a petition to restrict the approved labeled use of oxycodone to “severe pain,” DEA said that “abuse of prescription opioids have increased markedly over the past decade.” In the letter DEA also expressed support for the legitimate and beneficial
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
Significant Shift in Drug Diversion
Go West, young man!
The Wall Street Journal published a very interesting article on the shift in drug diversion trends within the United States. DEA has very publicly focused its enforcement efforts on South Florida pill mills as well as other problematic locations in the Eastern United States. According to information obtained by the Wall