By Anne K. Walsh – With no fanfare, the U.S. Supreme Court on Monday denied a writ of certiorari in a case watched closely by the drug and device industry. As reported earlier, the former CEO of InterMune Inc., Scott Harkonen, had filed a petition asking the …
By John R. Fleder – On August 8, 2013, we reported on a brief filed by the Department of Justice in United States ex rel. Ge v. Takeda Pharmaceutical Company Limited. The case involves the defendants’ alleged failure to timely report to FDA adverse drug events …
The Food and Drug Law Institute (“FDLI”) will hold is annual – and quite popular – Enforcement, Litigation and Compliance Conference from December 10-11, 2013 at The Westin Georgetown in Washington, DC. You can register for the conference here. A copy of the conference agenda …
By Dara Katcher Levy – We recently became aware of a lawsuit filed against FDA in the Eastern District of New York over the importation of bulk drug product. In this suit, which also names an individual FDA Compliance Officer, the importer argues that FDA’s actions …
The American Conference Institute will be holding its inaugural forum oncurrent Good Manufacturing Practices (“cGMPs”) in Washington, D.C. from Thursday, January 23 to Friday, January 24, 2014. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Douglas B. Farquhar …
By Dara Katcher Levy – A new Warning Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) suggests that FDA may want a new fight when it comes to the issue of that pesky First Amendment and the interplay with FDA-regulated products. In a November 8, …
By Jessica A. Ritsick, Jay W. Cormier & John R. Fleder – If you have ever needed to determine whether pulling an FDA-regulated product from retail shelves is a “market withdrawal” or a “recall” you know that the line between these two terms at times is murky …
By John R. Fleder – On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen. The government alleges that the defendants violated the FDC Act by introducing adulterated …
By Kurt R. Karst – It was not a question of whether, but when FDA would issue its first Warning Letter to a facility covered by the Generic Drug User Fee Amendments of 2012 (“GDUFA”) that failed to self-identify its facility and pay applicable user fees. …
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
By Kurt R. Karst – Earlier this year, FDA’s Dallas District Office issued a Warning Letter to Sovereign Pharmaceuticals, LLC (“Sovereign”), a pharmaceutical contract manufacturing facility located in Fort Worth, Texas, containing a rather interesting – and quite perplexing – violation tagged under the heading “Unapproved …
By Anne K. Walsh – Refusing to give up his fight to overturn his felony conviction, the former CEO of InterMune Inc., Dr. Scott Harkonen, recently filed a petition asking the U.S. Supreme Court to review his case. Harkonen asserts that the government violated his …
By John R. Fleder – For many years, FDA has taken the public position that nongovernmental entities cannot enforce the Federal Food, Drug, and Cosmetic Act. That position has not deterred lawsuits against businesses under statutes other than the FDCA, arguing that the defendants’ conduct violated …
By JP Ellison – Last week, John Roth, the Director of FDA’s Office of Criminal Investigations posted on FDA’s blog, FDA Voice. His post concerned a criminal case that had interested us about a Montana resident who had pled guilty and been sentenced on a …
By Kurt R. Karst – In a unanimous decision handed down on July 23rd by a 3-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit in Cook v. FDA (Case No. 12-5176), the Court largely affirmed a March 2012 decision …
