By Kurt R. Karst – The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, …
By Kurt R. Karst – FDA’s recent announcement that the Agency seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories (“Ascend”) is the latest, and most clear example yet of FDA taking action pursuant to the Agency’s September 19, 2011 Marketed Unapproved Drugs …
By JP Ellison & Anne K. Walsh – On May 22, 2014, the Justice Department announced that it had made a significant policy change regarding its policy concerning whether to electronically record statements made by individuals. A copy of the relevant DOJ memo is available here. Beginning …
By Riëtte van Laack – The FDC Act, as amended by the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, excludes from the definition of dietary supplement any article that is approved as a new drug and any article “authorized for investigation as a new …
By Kurt R. Karst – Shortly after Massachusetts Governor Deval Patrick issued a press release on March 27, 2014 announcing a Declaration of Emergency and that the Governor had directed the Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, to take several actions …
By Anne K. Walsh – The Supreme Court of Arkansas recently overturned (here and here) a lower court’s $1.2 billion award to the State of Arkansas, and also reversed and remanded the decision granting over $200 million in attorney’s fees and costs to the state. Putting …
By Riëtte van Laack – Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products – Diabetic Pack and Insulin Resistance – as medical foods. In 2005 and 2006, FDA issued two Warning letters to them (here and here), claiming the products …
By Anne K. Walsh – Yes, this post relates to yet another off-label settlement between a pharmaceutical company and the federal government. But some aspects of this recent settlement, coupled with other recent cases, might indicate noteworthy trends in how these cases are being resolved. The …
By Robert A. Dormer – Every breath you takeEvery move you makeEvery bond you breakEvery step you takeI'll be watching you Every single dayEvery word you sayEvery game you playEvery night you stayI'll be watching you Our apologies to Sting and The Police, but we were reminded of the …
By JP Ellison – On February 25th, the Solicitor General’s Office weighed in on whether the Supreme Court should take up a case involving False Claims Act allegations arising out of alleged off-label promotion of a drug. The case is Nathan v. Takeda, and the United States …
By John R. Fleder – In litigation brought by or against FDA, the agency frequently seeks to avoid a “jump-ball” by arguing that FDA’s position is entitled to deference by the court. That argument is consistently made in civil cases and has been made in some …
By Jennifer M. Thomas – The writers of this blog have often noted with dismay Relators’ attempts to enforce the FDCA and FDA regulations through the False Claims Act. Here, and here, for example. Last week, the Fourth Circuit confirmed that this is a losing strategy …
By JP Ellison – In a speech on January 29th at the CBI Pharmaceutical Compliance Congress that DOJ posted on its own website, U.S. Department of Justice Assistant Attorney General Stuart Delery set forth his views of the three ways that the government’s enforcement interests align with …
By John R. Fleder – On October 2, 2013, HP&M posted the following on this blog: On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen. The government alleges …
By Riëtte van Laack – On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s …
