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 …
By Kurt R. Karst – Earlier today, FDA sent a letter to Senator Charles Grassley (R-IA) indicating that the Agency may very well be poised to increase prosecution of company officials. According to the letter, which includes several recommendations based on a committee the Agency formed …
The Washington Legal Foundation has published a Legal Opinion Letter authored by Hyman, Phelps & McNamara, P.C., attorneys Jeffrey N. Wasserstein and Nisha P. Shah. The article, with the catchy title "Court Empowers Qui Tam Defendants To Sue Third Parties For Indemnification," expands on our …
By Peter M. Jaensch & John R. Fleder – The January 21, 2010 Federal Register contains a notice that the United States Sentencing Commission has proposed amendments to the Sentencing Guidelines and their Commentary concerning corporations and other business organizations. In addition, the Commission has raised an issue …
By Peter M. Jaensch – On January 14, 2010, the U.S. Attorney’s Office for the District of Massachusetts issued a statement announcing the charging of Doctor Scott Reuben, a former Chief of Acute Pain at Bay State Hospital in Springfield, Massachusetts, with one count of …
By William T. Koustas & John R. Fleder – A new lawsuit challenges the government’s ability to exclude individuals from participating in federal health care programs after a person has been convicted of a Food, Drug and Cosmetic Act (“FDCA”) misdemeanor. Michael Friedman and Howard R. Udell …
By John R. Fleder – On December 4, 2009, the United States Court of Appeals for the Eleventh Circuit in Atlanta issued a 24-page Opinion in James Hopper v. Solvay Pharmaceuticals, Inc., No. 08-15810. The Court affirmed the District Court’s dismissal of a False Claims Act …
By Ricardo Carvajal – FDA has again posted a warning letter to Procter and Gamble stating that the company’s VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C are unapproved new drugs and are misbranded. The letter states that, when “drug and dietary …
By Jeffrey N. Wasserstein – On October 28, 2009, Michael Loucks, the Acting U.S. Attorney for the District of Massachusetts, announced that his office has recovered over $6.8 billion in healthcare fraud cases over the last 15 years, which is almost 30% of the total healthcare …
By Dara Katcher Levy – On October 21, 2009, First Fishery Development Services filed suit against FDA seeking declaratory judgment and injunctive relief with regard to its product’s placement on Import Alert 99-08 – Detention Without Physical Examination of Processed Foods for Pesticides. According to the …
By JP Ellison – Last year we posed the question “Are the Stars Lining Up for FDA Civil Penalties?” The intervening year has not answered that question, but a recent decision from the Tenth Circuit affirming civil penalties against TMJ Implants, Inc. (“TMJI”) and its founder …
