By Jeffrey K. Shapiro – FDA has just issued a draft guidance document titled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements” (Docket No. FDA-2013-D-0114) intended to clarify how to distinguish product “corrections” from product “enhancements.” Although the draft guidance would be applicable …
An article published by Law360 and co-authored by H. Keeto Sabharwal and Dennies Varughese of Sterne Kessler Goldstein & Fox PLLC, and Kurt R. Karst of Hyman Phelps & McNamara PC, examines whether, and to what extent, a successful Inter Partes Review (“IPR”) challenge by a …
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 Larry K. Houck – The Government Accountability Office (“GAO”) has issued a report assessing the approaches states have taken to restrict the sales of pseudoephedrine (“PSE”), an ingredient commonly found in over-the-counter cold and allergy medications and a primary ingredient in clandestinely manufactured methamphetamine. U.S. …
By Jennifer D. Newberger – FDA issued a proposed rule to amend its regulations on acceptance of data from medical device clinical studies. The primary proposed changes include: Requiring that clinical studies conducted outside the United States to support any submission to FDA, including a 510(k) or …
By Ricardo Carvajal & JP Ellison – The U.S. Department of Justice ("DOJ") announced the indictment of former officials of the Peanut Corporation of America ("PCA") for their alleged role in the distribution of peanut products that were implicated in a 2008-2009 national outbreak of …
By Kurt R. Karst – In a widely anticipated move, Momenta Pharmaceuticals, Inc. and Sandoz Inc. have petitioned the U.S. Supreme Court to review the August 3, 2012 judgment of the U.S. Court of Appeals for the Federal Circuit, in which a divided (2-1) Federal …
In a new Contemporary Legal Note published by the Washington Legal Foundation (“WLF”), titled “Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations,” Hyman, Phelps & McNamara P.C. Director Douglas B. Farquhar explores issues surrounding privileged material and so-called “taint teams” when government investigators …
By Jennifer D. Newberger – The Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to require certain medical device submissions to include, “if readily available – (A) a description of any pediatric subpopulations that suffer …
By Carmelina G. Allis – As reported in FTC Watch Issue No. 823 (Feb. 13, 2013), the Federal Trade Commission has plans to increase enforcement actions against mobile apps – including mobile medical apps. During a Consumer Protection Conference sponsored by the American Bar Association earlier …
By Kurt R. Karst – A recent report from the National Institutes of Health (“NIH”) Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research leaves unanswered questions about the future utility of FDA’s so-called “Animal Efficacy Rule” for NIH-funded research intended …
By Riëtte van Laack – On February 13, the Center for Science in the Public Interest (“CSPI”) together with a coalition of 10 public health departments, 20 national health organizations, and 41 health and nutrition experts, submitted a 55-page petition to FDA requesting that FDA review …
By Alexander J. Varond – In response to FDA’s increasing reliance on Risk Evaluation and Mitigation Strategies (“REMS”) for the management of risks presented by certain drugs, the US Department of Health and Human Service’s Office of Inspector General (“OIG”) conducted an investigation into FDA’s …
By Jeffrey K. Shapiro – We are seeing the first fruits of a new device reclassification procedure added last summer to the Federal Food, Drug, and Cosmetic Act (“FDCA”). The new procedure modifies Section 513(e) of the FDCA to make it easier for FDA to reclassify …
By Jessica A. Ritsick – This week, the Institute of Medicine (“IOM”) released its report, commissioned by the FDA, “Countering the Problem of Falsified and Substandard Drugs.” The objective was to gain an understanding of the “global public health implications of falsified, substandard, and counterfeit …
