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March 5, 2013 News for the food and drug law community   Drugs & Biologics  Supreme Court to hear arguments on generic drug liability This month, Supreme Court justices will hear arguments in the case of a Maine woman suing a generic-drug maker over claims of damage from a generic nonsteroidal anti-inflammatory drug. The maker of the treatment says it cannot be held liable because it was not responsible for the design of the drug. The New York Times (tiered subscription model) (3/4) Congress hears from many over regulation of compounders As Congress begins to consider changes in the regulation of specialty pharmacies, drugmakers are calling for oversight or limits for compounders that act as mass producers or make "knockoff" medications for humans and animals. Hospitals want to avoid regulations that exacerbate drug shortages. The Washington Post (3/2) EU approves Roche's Perjeta for metastatic breast cancer The European Medicines Agency OK'd Roche Holding's Perjeta, or pertuzumab, in combination with trastuzumab and docetaxel, to treat women with previously untreated HER2-positive metastatic breast cancer. The approval followed the release of data from a late-stage trial, which showed that patients who took a combination of Perjeta, trastuzumab and chemotherapy survived 6.1 months longer without their disease progressing than those who received trastuzumab and chemotherapy. Fox Business/Dow Jones Newswires (3/5) FDA rejects Bayer-J&J's Xarelto for acute coronary syndrome The FDA turned down for the second time an application for the expanded use of blood thinner Xarelto, or rivaroxaban, in patients with acute coronary syndrome. The drug, developed by Bayer and Johnson & Johnson, has been cleared for six other indications. Reuters (3/4), Forbes (3/4) Report: U.S. wants stronger drug patent protection in TPP The U.S. is pushing for regulations that would improve patent and data protections for drugmakers at the 16th round of talks of the Trans-Pacific Partnership in Singapore this week, according to a brief from the humanitarian group Medecins Sans Frontieres. Inter Press Service (3/5), The Japan Times (3/5), ChannelNewsAsia.com (Singapore) (3/4) Canada warns against skin reactions tied to Vertex's Incivek Health Canada issued a public advisory about the possibility of serious skin reactions with the hepatitis C treatment Incivek from Vertex Pharmaceuticals. The move comes two months after the FDA released a similar warning. RTT News (3/1)   Global Focus  Tax increase should have minimal impact on India's drug industry Excise tax increases on drug imports to India should have little impact on the current robust growth of the Indian pharmaceutical industry, according to a report by global analytics company Crisil. The firm projects a domestic growth rate year-over-year increase of 16% to 17% through 2014, coupled with export increases of 17%, as India increasingly taps into generics and manufacturing opportunities for bulk drugs. The Economic Times (India)/Press Trust of India (3/3)   Food & Dietary Supplements  FDA asks for public comments on food traceability report The FDA is seeking public comment on a report about two pilot initiatives under the Food Safety Modernization Act. The agency will use the feedback along with the report to develop a rule on record-keeping to enhance the ability to track food. FoodSafetyNews.com (3/5)   Medical Devices  FDA OKs Bluetooth-enabled blood glucose monitor from LifeScan LifeScan has received FDA approval for its OneTouch Verio Synch system, which is used to monitor blood glucose in diabetes patients. The technology uses Bluetooth connectivity to allow patients to wirelessly receive personalized data, including a 14-day summary of glucose test outcomes, via an iPad, iPhone or iPod touch. Healio/Endocrine Today (3/4) FDA examines complications tied to Intuitive's surgical robot The FDA reportedly is conducting a survey on complications experienced by doctors in using Intuitive Surgical's da Vinci surgical robot after receiving increased incident reports tied to the device. Doctors in the survey also were asked about the training they obtained in using the technology as well as about procedures that may or may not be ideal for the device. MassDevice.com (Boston) (3/1) Risk of brain damage prompts recall of Ad-Tech's subdural electrodes Ad-Tech Medical Instrument is recalling its Macro Micro Subdural Electrodes that were produced between June 2006 and March 2012. The recall is prompted by concerns that the devices could trigger hemorrhage or brain damage that could result in infarction or seizures, according to an FDA notice. MassDevice.com (Boston) (3/4) AdvaMed CEO raises concerns over fallout from sequestration The FDA's budget and the user fees paid by the medtech industry will be affected by the automatic budget cuts known as sequestration, said AdvaMed President Stephen Ubl, who adds that his group is working to make a case about the adverse effects of those cuts. Ubl also expressed concern that political distractions are complicating industry efforts to strike down the medical device tax. "It clearly makes it harder to focus individual members [of Congress] on the harmful impacts of the tax," he said, "[But] I think we’re off to a very strong start this year." Star Tribune (Minneapolis-St. Paul, Minn.) (3/2)     FDLI Items  2013 conference calendar -- speak, register & save the dates! There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include: Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C. Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C. FDLI Annual Conference | April 23-24 | Washington, D.C. FDLI International Conference | June 6-7 | Beijing, China. New date! Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C. Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Location TBD FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C. Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C. Learn more about FDLI -> About FDLI  |  Join FDLI  |  Conferences  |  Publications Position Title Company Name Location Associate Director, Regulatory Affairs Celgene Greater New York City Area, NY Project Manager, Drug Safety and Innovation The Pew Charitable Trusts Washington, DC Advertising and Promotions Counsel Princeton Legal Search Group, LLC Washington, D.C., DC Counsel II, Legal (Anti-corruption) Gilead Sciences Foster City, CA Click here to view more job listings.   SmartQuote  It is with words as with sunbeams -- the more they are condensed, the deeper they burn." --Robert Southey, British poet     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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