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 …
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Animal Drugs and Feeds
- Generic BAYTRIL Approval Suspended; Bayer Alleges ANADA Approval Violates GADPTRA and APAApril 15th, 2013
- Waxman, Slaughter Introduce Bill to Ramp Up Reporting on Antimicrobial Drug Use in Animals as Senate Considers Animal Drug User Fee AgreementsFebruary 27th, 2013
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 …
- FDA Issues Draft Compliance Guide on Pet Food Intended to Diagnose, Cure, Mitigate, Treat or Prevent Disease, Including ObesitySeptember 21st, 2012
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 …
- The Clock Ticks Away on AAFCO’s Ingredient Definition ProcessAugust 22nd, 2012
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 …
- In Litigation Over Animal Feed Antibiotic Withdrawals, District Court Says FDA Needs to Move ForwardAugust 22nd, 2012
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 …
- FDA Requests Comments on Changes for Reporting Requirements of Antibiotic Use in Food Producing AnimalsAugust 2nd, 2012
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 …
- FDA Takes Another Hit in Court in Animal Feed Antibiotics Litigation; Court Says Agency’s Petition Denials Are Arbitrary and CapriciousJune 6th, 2012
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 …
- Franck’s Lab Takes FDA to Task in the 11th Circuit; Picks Off Each of the Government’s ArgumentsApril 12th, 2012
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 …
- Nonprofit Groups Prevail in Lawsuit Against FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal FeedMarch 27th, 2012
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 …
- FDA Publishes Order Prohibiting the Extralabel Use of Antimicrobial Cephalosporins in Food-producing Major SpeciesJanuary 11th, 2012
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 …
- Franck’s Lab Ruling Casts Doubt on FDA’s Use of Guidance Documents, Say HP&M AttorneysDecember 22nd, 2011
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 …
- Representative Slaughter Criticizes FDA’s Inaction Concerning the Use of Antibiotics in Animal AgricultureDecember 4th, 2011
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 …
- Federal District Court in Florida Delivers a Decisive Blow to FDA’s Authority to Regulate Pharmaceutical Compounding from Bulk SubstancesSeptember 18th, 2011
By Karla L. Palmer & Jeffrey N. Gibbs – Marking a significant victory for the pharmaceutical compounding industry, a Florida federal district court ruled that FDA did not have authority to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food …
- In a Rare Move, District Court Extends 30-Month Stay on FDA ANADA ApprovalJune 20th, 2011
By Kurt R. Karst – Although many have tried (see, e.g., here), in our experience, few have succeeded in convincing a court to decide to grant a motion to extend a 30-month stay on FDA’s approval of a generic drug application. (The most recent case we …
- Nonprofit Groups Sue FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal Feed, Seek Approval Withdrawals and Citizen Petition ResponseMay 26th, 2011
By Kurt R. Karst – A group of nonprofit organizations has filed a Complaint seeking to compel FDA, by a court-ordered deadline, to withdraw approval for subtherapeutic uses of penicillin and tetracyclines in animal feed and to issue a final response to two Citizen Petitions submitted …