Food, Drugs and Devices Tab Monthly Update
November 2013
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Topic of the Month: The FDA announced two actions to enhance the agency’s efforts to reduce the number of drug shortages in the United States: (1) a strategic plan initially required under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012; and (2) a proposed rule requiring that all manufacturers of prescriptions deemed medically important by the FDA to notify the agency of any disruption in the supply chain. According to the FDA, the actions address the potential significant public health threats caused by drug shortages. These actions follow President Obama’s Executive Order 13588 in 2011 intent on reducing drug shortages. Since the Executive Order was issued, the FDA noted that there had been a six-fold increase in the number of notifications. The FDA also reported that new drug shortages were halved in 2012 compared to 2011, from 251 shortages to 117.
I. Food Developments
FDA request to delay issuance of proposed food safety regulations refused
The FDA is required submit a notice of proposed rulemaking (NPRM) regarding intentional adulteration rules by the court-ordered November 30, 2013 deadline. Although the FDA requested a stay pending the appeal of the court’s order, there was no reason to grant it, because the court determined that submitting the NPRM was unlikely to cause irreparable harm to the FDA. Center for Food Safety v Hamburg, ¶39,462
II. Drugs and Biologics Developments
Perampanel proposed as Schedule III controlled substance
The Drug Enforcement Administration (DEA) is proposing to place the substance perampanel [2-(2-oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate], including its salts, isomers, and salts of isomers, into Schedule III of the Controlled Substances Act (CSA). f finalized, this Proposed rule would impose regulatory controls and administrative, civil, and criminal sanctions of Schedule III controlled substances on individuals who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, and possess) or even propose to handle perampanel. This Proposed rule is based on a recommendation from the Assistant Secretary for HHS and on an evaluation of all other relevant data by the DEA. Comments on the proposal should be submitted no later than November 21, 2013. DEA Proposal, ¶46,211
FDA proposes changes for annual report on data collected from sponsors of antimicrobial new animal drugs
The FDA has issued a proposed rule regarding the content and format of data tables for its annual summary report of sales and distribution data collected from sponsors of antimicrobial new animal drugs, in accordance with the new animal drug records and reporting provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). Comments on the proposed rule are due November 23, 2013. FDA Proposal, ¶46,210
Failure to warn claims preempted by federal law
Pro se products liability claims brought against a generic drug manufacturer based on a failure-to-warn theory were preempted by federal law. Because the generic drug manufacturer was required to use the same FDA approved labeling as the brand manufacturer, and could not legally change the labeling even to add additional warnings, the state law claims alleging that the labeling was inadequate would conflict with FDA regulations and were therefore preempted. Ko v Mutual Pharmaceutical Company, Inc., ¶39,461
III. Medical Devices Developments
Users of Mirena intrauterine device given chance to amend deficient complaint
Three patients alleging health consequences as a result of their use of the Mirena® intrauterine device (IUD) were permitted to amend their complaint, which contained factual and legal deficiencies Bayer Healthcare Pharmaceuticals, Inc. (Bayer) filed a motion to dismiss arguing that the patients failed to allege how they were harmed and facts to support their specific causes of action. The court reserved the motion because it granted the patients 20 days to amend their complaint. Vanden Bosch v Bayer Healthcare Pharmaceuticals, Inc., ¶15,716
Anthony H. Nguyen, J.D.
Food, Drugs & Devices
Wolters Kluwer Law & Business
2700 Lake Cook Road
Riverwoods, Illinois 60015
Phone: 847.267.2476
FAX: 847.267.2514