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 …
By Jeffrey N. Wasserstein – As aficionados of all things social media (see our prior postings here, here, here, and here) (other than kitten videos, enough with those already!) we couldn’t help but notice a recent Untitled Letter to Warner Chilcott, LLC, relating to a YouTube video. A …
By John R. Fleder – In 2004, the Federal Trade Commission (“FTC”) brought a civil action against the marketers of products sold as “Coral Calcium Daily” and “Supreme Greens with MSM.” The FTC challenged a number of claims, including that the products allegedly made express or …
By Kurt R. Karst – FDA’s recent move to remove from the market hundreds of unapproved cough, cold, and allergy drug products has spawned two new lawsuits that might very well be one of the last hurrahs for court challenges to FDA Drug Efficacy Study Implementation-related …
By Peter M. Jaensch - In the latest installment in the criminal prosecution of Lauren Stevens, an attorney formerly employed by GlaxoSmithKline ("GSK"), the U.S. Department of Justice announced on April 14, 2011, that a grand jury in the U.S. District Court for the District of …
By Dara Katcher Levy – FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) has announced that it will be holding a series of Enforcement Webinars that will provide an opportunity for attendees to ask DDMAC questions about the Warning and Untitled Letters it issues each …
By Roger C. Thies – On March 30, 2011, FDA publicly announced that it would not take enforcement action under certain conditions against pharmacies that compound hydroxyprogesterone caproate for injection for the reduction of the risk of certain preterm births in women who have had at …
By Roger C. Thies – FDA announced on March 30, 2011 that it “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or …
