…pending final disposition of forfeiture proceedings would cause substantial hardship to the claimant, such as preventing ongoing business, preventing an individual from working or leaving an individual homeless; (4) the…

…include all relevant information and documentation to support the WAC increase, which may include: all factors that have contributed to the WAC increase; the percentage of the total WAC increase…

…customers in the U.S. typically violates the Federal Food, Drug, and Cosmetic Act and in the case of controlled prescription drugs, the Controlled Substances Act.” The Agreement also states that…

…or overseeing investigations of DEA registrants.  The report also notes that “Division management” reviews cases “being elevated for disciplinary action (civil or criminal)” but does not identify whether, by referring…

…the Purdue case in which four high level individuals also pled guilty, in the present case, no individual pleas were announced in connection with the Abbott resolution, and the publicly…

By Ricardo Carvajal & Wes Siegner – The Department of Health and Human Services Office of Inspector General released two reports (see here and here) critical of dietary supplements in the…

…civil money penalty authority under Jarksey, in a case over the sale of an electronic cigarette without FDA authorization. Given the time that a case under Ohio v. EPA or…

By Kurt R. Karst –       Public shaming has been used as a type of punishment for centuries and has taken on many forms.  In Colonial America, for example, physical forms…

…misconduct gave rise to a civil or criminal resolution” so that both sides can “distinguish[] conduct that is lawful and even beneficial from conduct that is illegal and harmful.” Delery…

…sue on behalf of the federal government. As with nearly all statutes that provide for a civil recovery of damages, the FCA contains a statute of limitations, which requires the…

…CSA that have already taken effect, and does not add additional requirements.” Id. Definition of “Anabolic Steroid” To address exploitation of the earlier narrow statutory definition of “anabolic steroid,” DASCA…

…for general, non-PHN related pain indications, including lower back pain, diabetic neuropathy, and carpal tunnel syndrome.  The company’s global settlement included a civil payment of $171.9 million, a criminal fine…

…the court. That argument is consistently made in civil cases and has been made in some criminal cases. A Supreme Court ruling on February 26, 2014, raises a serious question…

By JP Ellison – On February 24, 2014, the U.S. Department of Justice announced a civil lawsuit and partial settlement arising out of alleged violations of statutes enforced by the Consumer…

…the previously delayed final rule implementing the 340B Drug Discount Program (“Final Rule”). The Final Rule, which was originally published on January 5, 2017, established the methodology for calculating the…