By Karla L. Palmer & Jeffrey N. Gibbs – On April 10, 2013, the Department of Health and Human Services’ Office of Inspector General (“OIG”) released a Memorandum Report titled, “High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them.” The OIG Report provides …
As it does every spring, the Federal Trade Commission (“FTC”) has released its annual report. The new report, which covers 2012, makes clear that the FTC remains as focused as ever on health-related advertising – especially where advertising allegedly promotes products for weight loss or …
By Kurt R. Karst – “GADPTRA” – Now there’s an acronym you don’t see very often on this blog. It stands for the Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman …
By Karla L. Palmer & Jeffrey N. Gibbs – On Thursday, April 11, 2013, FDA published a statement titled, “2013 FDA Pharmacy Inspection Assignment,” addressing the unprecedented recent nationwide wave of aseptic pharmacy inspections. The Agency states that it had taken critical look at its …
By Kurt R. Karst – Earlier this week, the Obama Administration released the President’s Budget for Fiscal Year 2014. At first blush, FDA appears to have fared rather well, with an additional $821,453,000 in total funding. Most of the increase, however, is due to new …
By Riëtte van Laack – On March 28, U.S. District Court Judge Richard Seeborg of the Northern District of California entered summary judgment for the defendants in a 2010 class-action lawsuit which had alleged that defendants misrepresented AriZona Iced Tea beverages containing “man-made” citric acid and …
By Kurt R. Karst – As food and drug attorneys, we rely on a certain level of FDA transparency to understand why FDA did what it did in a particular case, and to discern what that means for future Agency action (or inaction) in another …
By Ricardo Carvajal – Section 204 of the Food Safety Modernization Act ("FSMA") directed FDA to establish pilot projects “to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats …
By Etan J. Yeshua & Kurt R. Karst – Last Friday, a federal district court judge, in a 59-page decision, ordered FDA to make the emergency contraceptive PLAN B (levonorgestrel) available Over-the-Counter (“OTC”) and without age restrictions. In doing so, Judge Edward R. Korman of …
By Riëtte van Laack – Under the Organic Food Production Act (“OFPA”), the National Organic Program (“NOP”) of the USDA is authorized to establish the National List of Allowed and Prohibited Substances (“National List”). This National List contains each synthetic substance that is permitted and each …
By Delia A. Stubbs – As previously reported, Congress recently introduced the Stop Oxy Abuse Act that would restrict the labeled indications for use of any controlled release drug containing Oxycodone-Hydrochloride (HCl) to “severe-only” versus current labeling of “moderate-to-severe” pain. The legislation is similar to a recent …
By Kurt R. Karst – A recent Complaint filed in the U.S. District Court for the Southern District of Florida by Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (collectively, “Accord Healthcare”) against Acorda Therapeutics Inc. (“Acorda”) and H.D. Smith Wholesale Drug Co. (“H.D. Smith”) is the …
By Ricardo Carvajal – When FDA published its proposed rule on preventive controls as authorized by FSMA, we noted that FDA requested comment on a number of important issues that were not addressed in the text of the regulation itself, namely product testing, environmental monitoring, and …
