Earlier this week we gave a “Coming Soon” announcement about a forthcoming posting of an FDA-related crossword puzzle written by Jeffrey N. Gibbs and Etan J. Yeshua as part of a celebration of Hyman, Phelps & McNamara, P.C.’s 34th anniversary earlier this month. Well, it’s here …
By Anne K. Walsh – The Supreme Court of Arkansas recently overturned (here and here) a lower court’s $1.2 billion award to the State of Arkansas, and also reversed and remanded the decision granting over $200 million in attorney’s fees and costs to the state. Putting …
By Kurt R. Karst – Earlier this week, Senator Richard Blumenthal (D-CT) and Representatives Joaquin Castro Joaquin Castro (D-TX) and Randy Forbes (R-VA) introduced the “Independent Innovator and Repurposing Act” in their respective houses of Congress (S. 2150; H.R. 4287). Styled as a bill “[t]o advance …
By Ricardo Carvajal – FDA announced that it has implemented a new electronic reporting tool for livestock animal food problems, which the agency refers to as the Livestock Food Reporting Portal. Essentially, the portal expands the categories of reports that can be submitted through the Safety …
By Kurt R. Karst – In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively “Perrigo”) (represented by Hyman, Phelps & McNamara, P.C.) allege that FDA has shirked a duty under the …
(In our best Don LaFontaine voice) IN A WORLD where food and drug attorneys and regulatory professionals are all work and no play, there’s something coming to relieve the monotony and to spice up your work life. That’s right, after a very, very long hiatus, our “Lighter Side …
By Kurt R. Karst – Since we started this blogging gig seven years ago (March 6th was our anniversary) we’ve strived to cover topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested …
The Food and Drug Law Institute (“FDLI”) recently announced that President and Chief Executive Officer Susan C. Winckler will step down from that position effective May 23, 2014. Ms Winckler, a pharmacist and attorney, was named to the position in November 2009. She previously served …
By Allyson B. Mullen – On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”). FDA, Guidance for Industry and FDA Staff, Administrative Procedures for CLIA Categorization (March 2014). The 2014 Guidance replaces the final …
By Kurt R. Karst – It was just a little more than three months ago that we blogged on the topic of “premature notice” in the context of a Complaint filed by Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) against Par Pharmaceutical, Inc. (“Par”) concerning Par’s notice of …
By John A. Gilbert – The 57th session of the Commission on Narcotic Drugs (“CND”) recently convened in Vienna, Austria. A prominent issue on the first day of the general session included concern over the increased use of cannabis, especially for recreational purposes. The International Narcotics …
By Riëtte van Laack – On March 13, 2014, U.S. Senator Jack Reed (D-RI) and U.S. Representative Ed Whitfield (R-KY) introduced the “Sunscreen Innovation Act” (S. 2141 and H.R. 4250, respectively). The proposed legislation would amend the FDC Act to include a process for the review …
By Wes Siegner – Does meeting the FTC legal standard for claim substantiation protect claims from action by the National Advertising Division (“NAD”)? If you think the answer should be “yes,” read on. FTC consent decrees often leave open the possibility that unsubstantiated claims may be resumed …
By Dara Katcher Levy – We have long been waiting for a company to sue FDA for failing to issue an export certificate. Unfortunately, we may need to wait a bit longer for a case that will resolve the standards for when FDA must issue an …
By Riëtte van Laack – Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products – Diabetic Pack and Insulin Resistance – as medical foods. In 2005 and 2006, FDA issued two Warning letters to them (here and here), claiming the products …
