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 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 – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
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 Kurt R. Karst – On Tuesday, February 26th, Representatives Henry Waxman (D-CA) and Louise Slaughter (D-NY) announced the introduction of H.R. 820, the Delivering Antimicrobial Transparency in Animals Act of 2013 (“DATA Act”). Introduction of the DATA Act comes just as the U.S. Senate …
By Riëtte van Laack – Earlier this month, FDA announced the publication of a draft level 1 Compliance Policy Guide (“CPG”) titled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” The CPG in clear …
By Ricardo Carvajal & Diane B. McColl – Back in April, FDA’s Center for Veterinary Medicine ("CVM") notified industry of its decision to extend the agency’s Memorandum of Understanding ("MOU") with the Association of American Feed Control Officials ("AAFCO") for one year (the MOU was scheduled to …
By Kurt R. Karst – The decades-long saga over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals is likely to continue for some time given an August 8, 2012 decision from the U.S. District Court for the Southern …
By Riëtte van Laack – The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare and publish annual summaries of antimicrobial animal drugs sold or distributed for use in food-producing animals. The data are derived from information submitted by sponsors of antimicrobial new …
By Kurt R. Karst – Magistrate Judge Theodore H. Katz of the U.S. District Court for the Southern District of New York has dealt FDA another loss in litigation over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals. In …
By Karla L. Palmer – Franck’s Lab Inc., a pharmacy that compounds veterinary drugs and whose bulk animal drug compounding activities were vindicated by a Florida federal district court last year, recently filed its Brief for the Appellees in the matter of United States v. Franck’s …
By Kurt R. Karst – In a decision that if left intact could have far-reaching implications for FDA, the U.S. District Court for the Southern District of New York recently granted a Motion for Summary Judgment filed by the National Resources Defense Council (“NRDC”) and three other …
By Riëtte van Laack – The Animal Medicinal Drug Use Clarification Act of 1994 (“AMDUCA”) amended the FDC Act § 512(a) allowing veterinarians to prescribe extralabel use of certain approved animal and human drugs for animals. (Extralabel use includes use in species not listed in the …
In a new Legal Backgrounder published by the Washington Legal Foundation, Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer and Jeffrey N. Gibbs write that a recent Florida federal district court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have …
By Riëtte van Laack – Representative Louise Slaughter (D-NY) recently sent a 4-page letter to FDA expressing her discontent with the Agency’s action (or lack thereof) related to antibiotic use in animal agriculture. Specifically, Rep. Slaughter criticizes: 1. FDA’s delay in finalizing the industry guidance #209, titled the …
