By Wes Siegner – We recently reported that on September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs …
By John R. Fleder – It is no secret that the government has devoted considerable resources in recent years seeking to combat what it has contended is wide-spread illegal off-label marketing and promotion of devices and drugs. Many people believe that the government has created this …
By William T. Koustas – We have previously reported (here and here) continuing legal saga of the former Purdue Frederick Co. (“Purdue”) executives who are seeking to reverse a Department of Health and Human Services (“HHS”) decision to exclude their participation in federal healthcare programs. In …
By Kurt R. Karst – On September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”) (FDA Docket No. 2003D-0478), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved …
By Wes Siegner, John R. Fleder & Ricardo Carvajal – In U.S. v. Scenic View Dairy, LLC, et. al., the government prevailed on summary judgment in an injunction action against dairy farms alleged to market cows bearing unlawful drug residues. Although nominally a veterinary drug case, …
By Carmelina G. Allis – If you thought you’ve had enough trying to figure out whether FDA regulates your mobile app, watch out for the FTC. The FTC has brought its first case targeting health claims related to mobile medical apps. The mobile apps, sold in Apple’s …
By William T. Koustas & John R. Fleder – Google, Inc. (“Google”) and the Department of Justice (“DOJ”) (acting in concert with FDA’s Office of Criminal Investigations) have settled the government’s criminal investigation into Google’s AdWords program, which displayed advertisements on websites for online Canadian pharmacies. …
By Kurt R. Karst – The court battle over the “new drug” status of Cody Laboratories, Inc.’s and Lannett Co., Inc.’s (collectively “Cody/Lannett’s”) Morphine Sulfate Oral Solution 20mg/mL drug product has taken a new turn. FDA’s Motion to Dismiss the case on mootness grounds has been …
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C.’s Douglas B. Farquhar discusses the recent and highly publicized directed verdict for Lauren Stevens, the former in-house lawyer at GlaxoSmithKline, who was on trial for charges that she, basically, lied to the …
By Kurt R. Karst – On July 19th, President Obama announced his intent to nominate Maureen K. Ohlhausen as a Commissioner of the Federal Trade Commission (“FTC”). Ms. Ohlhausen is currently a partner at Wilkinson Barker Knauer LLP, where she specializes in privacy, data protection, and …
By Peter M. Jaensch – On June 29th, 2011, the Washington Legal Foundation (“WLF”) filed an amicus curiae brief in Friedman v. Sebelius, currently pending in the U.S. Court of Appeals for the D.C. Circuit. WLF argues that excluding executives convicted of misdemeanor offenses under the …
By Riëtte van Laack – Recent FDA enforcement actions suggest that FDA will diligently pursue companies that have received Warning Letters for certain violations – and that have allegedly failed to clean up their act. U.S. Marshals recently seized product from UAS Laboratories (“UAS”), a probiotics dietary …
By Peter M. Jaensch – In what a federal grand jury charges was a several-months-long effort in 2010 to maintain their job security, a clinical trial investigator and clinical trial coordinator in Kansas allegedly falsified clinical drug trial study data in submissions to the Food and …
By Robert A. Dormer – In an August 2009 speech to the Food and Drug Law Institute, FDA Commissioner Margaret A. Hamburg, M.D., emphasized the importance of enforcement (see our previous post here). Among other actions announced by Dr. Hamburg was a warning letter “close-out” process. …
By John R. Fleder – In a stunning ruling on May 10, 2011, United States District Court Judge Roger W. Titus ruled from the bench in Greenbelt, Maryland, granting a Motion for a Judgment of Acquittal filed by the defendant, Lauren Stevens. Ms. Stevens was formerly …
