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…

By Ricardo Carvajal – The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services released a report that finds fault with FDA’s inspection activities for food…

It has become almost commonplace to see a weekly announcement of a False Claims Act settlement by a major pharmaceutical or medical device manufacturer. Perhaps that is why last month’s…

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

…H.R. 5982, 114th Cong. (2016), which would amend the Congressional Review Act to allow Congress, by joint resolution, to reject a group of regulations submitted by federal agencies for congressional…

…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…

…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…

…chemical synthesis processes including in the natural product syntheses of N-deoxymilitarinone A and torrubiellone B, potential pharmaceutical development, resin/materials development, and agricultural chemicals. One commenter, without providing details, asserted that…

…chemicals that can be used for illicit production of methamphetamine) to submit to the Attorney General an additional self-certification prior to selling at retail any SLCP.  This “enhanced” certification requires…

…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 ANDA was submitted.’  MMA §  1112(a)(2)(B).  That is the case notwithstanding that the stipulation was filed pursuant to Federal Rule of Civil Procedure 41(a) to secure a dismissal. ….

…2011, the synthetic cannabinoids known as JWH-018, JWH-073, JWH-200, CP-47,497 and cannabicyclohexanol are subject to the Schedule I regulatory controls and administrative, civil and criminal sanctions imposed by the CSA…

…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…