By Kurt R. Karst – The dispute between Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) and FDA over marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products did not end with the July 26, 2010 decision from the U.S. District Court for the District …
By William T. Koustas – Franck’s Lab, Inc. (“Defendant”), an Ocala, Florida veterinary compounding pharmacy, resumed compounding after a federal judge in the United States District Court for the Middle District of Florida denied the Government’s (“Plaintiff”) request for a preliminary injunction on August 19, 2010 that …
By Oisin A. Mulvihill* & Peter M. Jaensch – A recent string of high-profile pharmaceutical and medical device product recalls appears to be reigniting FDA’s interest in pressing misdemeanor charges against corporate executives under the Responsible Corporate Officer Doctrine, or Park Doctrine. Lewis Grossman, professor …
In the July/August 2010 edition of FDLI Update, HP&M attorneys John R. Fleder and Cassandra A. Soltis authored an article, titled “Advertising and Promotion: FDA Is Not the Only Cop on the Beat.” The article focuses on the various non-FDA groups that police alleged false …
By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) held a press conference in Chicago to announce a lawsuit against several companies, including Central Coast Nutraceuticals, iLife, Simply Naturals, Fit for Life, and Health and Beauty, for their marketing of acai berry weight-loss …
By Kurt R. Karst – The 60 Plus Association, a senior advocacy group and alternative to AARP, has joined the debate over marketed unapproved drugs, asking FDA to step-up enforcement action and starting its “Keep Seniors Safe” initiative, which “advocates the removal of unapproved …
By William T. Koustas – We have previously written that Regenerative Sciences (“Regenerative”), a Colorado-based stem cell company, filed a complaint in the U.S. District Court for the District of Columbia against FDA in order to enjoin it from regulating Regenerative’s use of cultured stem …
By Dara Katcher Levy - In what we believe is DDMAC’s first foray into tackling one of the “gray-areas” created by social media, on July 29, DDMAC issued an Untitled Letter to Novartis Pharmaceuticals for Rx drug content “grabbed” by a Facebook Share widget. For those that …
In the May/June 2010 edition of FDLI Update, HP&M Director John R. Fleder published his latest article on enforcement matters. This article is entitled “Whistleblowers: Treat Them With Kid Gloves.” The article addresses various issues that companies face when they are confronted with employees who …
By Peter M. Jaensch – On July 14, 2010, the Federal Trade Commission (“FTC”) announced an agreement with Nestle HealthCare Nutrition, Inc. (“Nestle”) to settle an FTC investigation with regard to alleged false and misleading health claims. The FTC's Complaint arose from claims made by …
By John R. Fleder – It is hardly a secret that FDA’s favorite regulated industry is certainly not the businesses that compound pharmaceutical products. For years FDA has struggled to establish an enforcement mechanism that passes muster with Congress and the courts. Two compounding pharmacies have …
By Kurt R. Karst – In recent weeks, two advocacy groups have sent letters to FDA requesting that the Agency enhance and accelerate its enforcement activities with respect to marketed unapproved drugs. FDA began its current Unapproved Drugs Initiative in June 2006 when the …
The March/April 2010 issue of FDLI Update contains an article by Hyman, Phelps & McNamara, P.C.’s Peter M. Jaensch and John R. Fleder that addresses the increasing number of cases brought under the federal Lanham Act law where plaintiffs have arguably sought to privately enforce the …
By Kurt R. Karst & Dara Katcher Levy – Last week, FDA issued Warning Letters (here and here) to Glenmark Generics (“Glenmark”) and Konec Inc. (“Konec”) for marketed unapproved and misbranded 0.3 mg, 0.4 mg, and 0.6 mg nitroglycerin sublingual tablets. According to the letters, …
By John R. Fleder – We earlier reported that the United States Sentencing Commission issued an interesting Federal Register notice on January 21, 2010. We reported that the Commission has proposed to amend the Sentencing Guidelines to require companies to make restitution to identifiable victims, and …
