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November 6, 2012 News for the food and drug law community   Drugs & Biologics  Novartis' kidney tumor treatment Votubia gains EU OK The European Commission approved Novartis' Votubia, or everolimus, to treat noncancerous kidney tumors in patients with tuberous sclerosis complex. Reuters (11/5) GSK's anthrax drug raxibacumab wins support of FDA panel An FDA advisory panel recommended the approval of GlaxoSmithKline's monoclonal antibody raxibacumab as a therapy for inhalation anthrax. The FDA is expected to decide on the drug's approval by Dec. 15. MedPage Today (free registration) (11/2), RTT News (11/2) Hamburg to testify in House hearing on meningitis outbreak FDA Commissioner Dr. Margaret Hamburg is set to testify before the House Energy & Commerce Committee on the fungal meningitis outbreak tied to tainted injectable steroids produced at the New England Compounding Center. The FDA will be questioned on its oversight of the pharmacy. NECC co-founder Barry Cadden and Massachusetts Board of Registration in Pharmacy director James Coffey could testify. The Hill/Healthwatch blog (11/5), The Washington Times/The Associated Press (11/5) Bleeding risk no greater with dabigatran than warfarin, FDA says The use of dabigatran as a treatment to prevent strokes is not associated with greater risks of bleeding than warfarin, according to the FDA's MedWatch adverse event reporting system. However, some critics in the medical community say dabigatran's risks may be exacerbated by the lack of an approved antidote to its anticoagulant effects. Medscape (free registration) (11/2), The New York Times (tiered subscription model) (11/2) Election results will likely affect FDA drug approval The FDA will be affected, in one way or another, by the results of the upcoming election. The FDA would largely continue with its current path if President Barack Obama gets re-elected, according to this blog post. On the other hand, the agency is likely to have a commissioner who is willing to move away from a focus on safety and take steps to speed approvals, notwithstanding budget cuts, if Republican challenger Mitt Romney wins, the blog post said. Pharmalot.com/Pharma Blog (11/5)     Global Focus  Indian officials warn against increasing sale of substandard drugs The sale of substandard drugs is increasing, India's drugs control department warns. "By conducting regular raids on the premises of medical stores and wholesale distributors, we have prevented huge quantity of substandard drugs from reaching the market," drugs control intelligence officer J.N. Philip said. The Times of India (11/5)   Food & Dietary Supplements  FDA should modify import safety approach, GAO says The Government Accountability Office has recommended that the FDA shift its plans under the the Food Safety Modernization Act to assess foreign countries' food safety systems for individual products, rather than their food safety systems in general. The FDA should rely more on comparability assessments such as those used by the USDA for meat and poultry products, according to a GAO report. FoodSafetyNews.com (11/5)   Medical Devices  Teleflex wins FDA nod for reusable surgical access systems The FDA has given Teleflex 510(k) clearance to market its Weck obturators, which are used during minimally invasive procedures to give surgical tools access. The reusable devices work with Teleflex's Weck Vista single-use cannulas and with the firm's Weck Vista line of bladeless ports for laparoscopic access. MassDevice.com (Boston) (11/5) Accreditation group OKs test to detect Campylobacter bacteria The Association of Analytical Communities has certified Invisible Sentinel's Veriflow assay, a pocket-sized device used to spot the Campylobacter bacteria commonly linked to chickens. The AOAC certification means the test is now recognized by the FDA and Department of Agriculture as well as certain regulatory counterparts in Europe and other markets abroad. MedCityNews.com (11/5) Premier calls device ID rule the "missing link" to patient safety The FDA's proposal to create a unique device identifier system to electronically track medical technologies has earned support from the Premier Healthcare Alliance, which said it will enhance adverse event reporting and make product recalls faster and more accurate. The move also could save the industry about $16 billion a year due to increased efficiencies, the group said in a comment letter to FDA Commissioner Margaret Hamburg. Healthcare Informatics online (11/2)   Tobacco  2 tobacco firms to request dismissal of lawsuit in Ontario R.J. Reynolds Tobacco and British American Tobacco will ask Ontario's highest court to dismiss a $50 billion lawsuit filed by the provincial government. The lawsuit is based on what they say is the incorrect idea that the companies conspired to keep information from smokers about the addictive and harmful components in cigarettes, lawyers said. CBC.ca (Canada)/The Canadian Press (11/5)   FDLI Items  Don't miss discussions on genetically modified food labeling -- Nov. 15 In recent years, there has been a flurry of significant cases and regulatory actions in food advertising and litigation, including Lanham Act competitor suits and self-regulatory challenges, consumer class actions, FTC enforcement actions, and FDA warning letters. These cases, many still ongoing, have had far-reaching implications for all food product advertisers. FDLI's Food Advertising: Claims, Litigation and Strategies conference will address these issues, including claims and substantiation for functional foods and health claims; key cases and settlements in 2012, and a look ahead to 2013; current FDA and FTC priorities; and strategies for dealing with, and avoiding, litigation issues. Latest Policy Forum: Reducing Unlawful Prescription Drug Promotion The newest issue of Policy Forum, Reducing Unlawful Prescription Drug Promotion: Is the Public Health Being Served by an Enforcement Approach that Focuses on Punishment?, examines the punitive model adopted by the FDA) and Department of Justice to discourage the unlawful promotion of prescription drugs. Author Victoria W. Girard, Professor of Legal Research and Writing at Georgetown University Law Center, explores the growth in settlements, penalties, and the recent efforts to hold individual executives liable for corporate misbehavior. She concludes that FDA and DOJ should not continue punishing corporate officers with monetary and criminal penalties unless they can demonstrate that corporate accountability and compliance are improving. Members: Download now. | Nonmembers: Purchase for $24.95 and download now. Learn more about FDLI -> About FDLI  |  Join FDLI  |  Conferences  |  Publications Position Title Company Name Location FDA Regulatory Associate Arnold & Porter LLP Washington, DC Sr. Brand Attorney Novo Nordisk Princeton, NJ Regulatory Counsel, Global Confidential Northern, NJ Senior Counsel - Regulatory and Quality Assurance Compliance The Procter & Gamble Company Cincinnati, OH Health & FDA Business Associate Greenberg Traurig Washington, DC Click here to view more job listings.   SmartQuote  Character is much easier kept than recovered." --Thomas Paine, British-American political activist and author     Subscriber Tools       Print friendly format | Web version | Search past news | Archive | Privacy policy Advertise Account Director:  Meryl Harold (202) 407-7828 Download Media Kit Job Board:  Jackie Basso (202) 407-7871   Read more at SmartBrief.com A powerful website for SmartBrief readers including: Industry Home Readers' Choice Search Archive Who's Hiring? 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