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 Delia A. Stubbs & Alan M. Kirschenbaum – Yesterday, in a letter to Representative Jim McDermott, Secretary of Health and Human Services (“HHS”) Kathleen Sebelius stated that qualified health plans (“QHPs”) and other programs related to health insurance exchanges under Title I of the …
By Kurt R. Karst – The forces backing implementation of an FDA policy under which biosimilar biological products, licensed under Section 351(k) of the Public Health Service Act (“PHS Act”) as added by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and their …
By Kurt R. Karst – The Generic Pharmaceutical Association (“GPhA”) held its annual Fall Technical Conference this week. There were lots of interesting topics on the conference agenda, such as complex drugs, ANDA filing and refuse-to-receive issues (see the recent FDA guidance here), adverse event …
By Ricardo Carvajal – We previously reported on a case – Wilson v. Frito-Lay North America, Inc. – in which a federal district court held that statements on a food company’s website do not constitute labeling even though the labels of some products include a reference …
By Delia A. Stubbs – The amount of government activity on issues involving controlled substances last week makes the furlough seem like a figment of our imagination. Following issuance of a press release on hydrocodone rescheduling and a court ruling on DEA’s delay on the scheduling …
By Kurt R. Karst – In a decision handed down on September 30, 2013 (but not unsealed until last Friday), the U.S. District Court for the District of Columbia rebuffed a challenge by Cumberland Pharmaceuticals Inc. (“Cumberland”) to FDA’s approval of a generic version of Cumberland’s acetaminophen …
By Delia A. Stubbs – Earlier this week, the U.S. Court of Appeals for the D.C. Circuit denied Eisai, Inc.’s (“Eisai’s”) petition to order DEA – in essence – to get moving on the scheduling of its drug, FYCOMPA (perampanel), which FDA approved in October 2012 …
By Delia A. Stubbs – While typically not made public, today, FDA issued a statement that it intends to forward a recommendation to DEA by December to move hydrocodone combination products from their current placement in Schedule III to Schedule II. That change would mean, among …
The Grocery Manufacturers Association ("GMA") is presenting a webinar on GRAS self-determinations for food ingredients next Tuesday, October 29 from 1:30 to 3:00 p.m. EST. The webinar is intended to help food businesses understand applicable requirements and avoid missteps in ingredient safety assessments, and will …
By David B. Clissold – The United States Government Accountability Office (“GAO”) recently released a report examining FDA’s Center for Tobacco Products (“CTP”) entitled, “New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process” (“GAO Report”). The report focused on CTP’s review of …
By Ricardo Carvajal – This past Monday, the European Food Law Association held its third conference on developments in food law in the EU and US. The conference was devoted entirely to the subject of food recalls and related public alerts, and the significant impact that …
By Riëtte van Laack – Jensen Farms, (the Jensens), the growers facing criminal charges related to the deadly 2011 listeria outbreak linked to their cantaloupes, are suing Primus Group, Inc. d/b/a/ Primus Labs (Primus) alleging that the food safety consultants who audited the Jensens’ facilities shortly …
By Kurt R. Karst – Now that the shutdown of the U.S. Federal Government is over and FDA’s Dockets Management Branch is open again, the backlog of docket submissions is rolling in on regulations.gov, including Citizen Petiton responses issued during the shutdown. One petition response …
By Kurt R. Karst – FDA’s recent response to two Citizen Petitions (Docket Nos. FDA-2013-P-0995 and FDA-2011-P-0869) helped to shed some additional light on an issue that continues to vex companies considering submitting a 505(b)(2) NDA to FDA for a new drug: When do I …
