By Kurt R. Karst – The recent controversy over the approval of generic versions of Sanofi-Aventis U.S. LLC’s (“Sanofi’s”) colon cancer drug ELOXATIN (oxaliplatin) is one for the books and will most certainly go down in Hatch-Waxman lore. The story begins in 2007 with patent infringement …
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at two upcoming conferences on various Hatch-Waxman issues. The first conference is the American Conference Institute’s (“ACI’s”) popular Maximizing Pharmaceutical Patent Life Cycles (10th Anniversary Edition), and is scheduled for October 6-10, 2009 at …
As directed by the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”), FDA has created its new Center for Tobacco Products (“CTP”). CTP will be led by Dr. Lawrence Deyton of the George Washington University School of Medicine and Health Sciences. FDA’s press release …
By Susan J. Matthees– The United States District Court for New Jersey recently denied a motion by the Federal Trade Commission (“FTC”) to hold Lane Labs-USA, Inc. (“Lane Labs”), Andrew Lane, and William Lane in contempt for allegedly violating a consent decree. Lane Labs entered into …
By Kurt R. Karst & Frank J. Sasinowski – A Senate floor amendment to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (H.R. 2997) would establish within FDA two new review groups to recommend solutions for the prevention, diagnosis, …
By JP Ellison – With the seemingly endless flow of news reports announcing yet another unsealed False Claims Act (“FCA”) case, and the regular announcement of FCA settlements for what would have only a few years ago been unheard of amounts, it is easy to …
By Susan J. Matthees – FDA has published a new draft guidance titled Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration. Last month we reported that the Alcohol and Tobacco Tax and Trade Bureau ("TTB") issued a …
By Ricardo Carvajal – Last year, a New Jersey district court held in favor of federal preemption of a state law consumer fraud claim against the manufacturer of a beverage that contains high fructose corn syrup (HFCS) and is labeled as “all natural” (see Holk …
By Ricardo Carvajal & JP Ellison – It’s been a busy month at the Alliance for Natural Health. In addition to suing FDA over its handling of health claims, the Alliance (in conjunction with other plaintiffs) has sued FDA to invalidate certain provisions of the …
By Michelle L. Butler – Today, August 14, 2009, is the anniversary of the passage of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), which means that a number of new requirements will go into effect. It also means that the Consumer Product Safety …
By Susan J. Matthees – The Federal Trade Commission (“FTC”) recently announced that an Administration Law Judge (“ALJ”) upheld FTC’s charges against a company, Daniel Chapter One, and its officer, James Feijo, for making claims that its shark cartilage and herbal supplements prevent, treat, and …
By Ricardo Carvajal – In conjunction with other plaintiffs, the Alliance for Natural Health has filed suit in the D.C. district court challenging FDA’s denial of plaintiffs’ petition for the use of four qualified health claims for selenium and certain forms of cancer, and FDA’s …
By Kurt R. Karst – On August 12th, FDA announced the publication of final regulations concerning “Expanded Access to Investigational Drugs for Treatment Use” and “Charging for Investigational Drugs Under an Investigational New Drug Application.” Both rules will be officially published in the August 13th …
By Carmelina G. Allis – The FDA has issued a Federal Register notice announcing a program that establishes a timeframe for the submission and agency review of responses to Form FDA-483s before the agency’s issuance of Warning Letters. This announcement is in line with our …
By Kurt R. Karst – Earlier this week, Astellas Pharma US, Inc. (“Astellas”) filed a Complaint and an accompanying Memorandum of Points and Authorities in the U.S. District Court for the District of Columbia requesting declaratory and injunctive relief in connection with FDA’s response to a citizen …
