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November 13, 2009 News for the biotech, medical device, drug and food regulatory profession     Drugs & Biologics  Drug, advertising executives defend online ads to FDA Representatives from the pharmaceutical and advertising industries warned the FDA that online drug ads cannot contain all risk information instantaneously because it will compromise clarity of the promotional material. Amy Cowan, head of industry for health at Google, said drug companies' search ads were "more relevant, transparent and informative" before the FDA warned 14 manufacturers about ads that did not state all risks associated with their products. The Wall Street Journal/Dow Jones Newswires (11/12) , MediaPost Communications/Online Media Daily (11/12) Hamburg: FDA is working to boost efficiency of drug regulation FDA Commissioner Margaret Hamburg said she will visit China next year to look into safety policies related to imported products. The agency is hiring more staff, leveraging science and working on other means to speed up drug-approval reviews, Hamburg said at the Reuters Health Summit. Reuters (11/12)   Health Care in Transition  Some CME firms resist proposal to disclose drug, device donations Some companies that provide continuing medical education for doctors are opposing a health reform measure that would require drug and device firms to report payments to physicians and third parties. Funding from the industry goes to classes that do not include specific products, in compliance with federal rules, said defenders of industry-aided continuing medical education. The Wall Street Journal (11/13) Europe could beat U.S. in biopharma innovation Europe could overthrow the U.S. as a leader in the biotech-drug industry if U.S. lawmakers decide to shorten market exclusivity for brand-name biopharmaceuticals under health reform legislation, writes Benedetto Della Vedova, former member of the European Parliament. A proposal to provide five to seven years of protection would stifle innovation and diminish the chance of U.S. companies to be globally competitive, giving way for European firms to create the next generation of biologic drugs, Della Vedova writes. The Wall Street Journal (11/12) Health reform could boost mergers in device sector, J&J exec says The medical-device industry is likely to see more mergers and acquisitions if the proposed industry tax in a health reform bill "puts more pressure on smaller med-tech companies," said Dominic Caruso, Johnson & Johnson's chief financial officer. Speaking at a conference, Caruso said the company plans to continue acquiring device firms as well as pursue buyouts and partnership deals in the field of consumer health products and pharmaceuticals. The Wall Street Journal/Dow Jones Newswires (11/12) Reid mulls increase in Medicare payroll taxes for higher-income earners Democratic sources revealed that Senate Majority Leader Harry Reid, D-Nev., is evaluating the possibility of increasing Medicare payroll taxes paid by families that earn more than $250,000 a year, to help the government raise $40 billion to $50 billion over 10 years to fund health care reform. A spokesman for Reid said the legislator has not yet decided whether to include such a proposal in the Senate's health bill that will be introduced next week. The New York Times (11/12) , The Washington Post/Capitol Briefing blog (11/12) Other News White House budget director optimistic about 2009 deadline for health bill Bloomberg (11/12)   Biotechnology  Interaction between 2 genes might serve as drug target for cancer Canadian researchers found that a surge in the level of Eph receptors, which are found at a high level in cancer, caused premature death in worms by reducing the level of tumor-suppressing gene PTEN. The connection between the two genes might be used as a therapeutic target for cancer, they said. United Press International (11/12)   Food & Dietary Ingredients  E.coli outbreak traced to ground beef producer's N.Y. facility A ground beef producer that had not tested its ingredients for some years recalled hundreds of thousands of pounds of its products after an E. coli outbreak was linked to its ground beef. AFA Foods said it is re-evaluating procedures, even though it says it already meets guidelines on best practices. The New York Times (free registration) (11/12)   Featured Content    The "Iterate Fast and Release Often" Philosophy of Entrepreneurship Ben Parr Forget the Phonebook: 3 Local Marketing Initiatives with Higher ROIs Gregory Go 5 Tips for Getting More Exposure from Bloggers, Tweeters and Fans John Jantsch An Interview with Henry Blodget Marcy Shinder from OPEN Book: Social Media Why It's So Difficult to Find Angel Capital Scott Shane   Medical Devices  Hamburg says FDA works to address problems at device unit FDA Commissioner Margaret Hamburg said the agency is seeking a new chief for the device unit and is working to address issues related to the division, including reviewing the 510(k) process. "We are working on some important issues that will benefit industry and benefit the ultimate outcome of our regulatory procedures, including making sure we have a robust internal review process," Hamburg said at the Reuters Health Summit. Reuters (11/12) Edwards CEO: Devices to face pricing pressure from hospitals As potential health care reform seeks to curb rising medical costs, hospitals could put pressure on the prices of medical devices and that could be "more intense in the future," said Michael Mussallem, Edwards Lifesciences' CEO and chairman of the Advanced Medical Technology Association. Reuters (11/12)   FDLI Items  Food and Drug Law and Regulation, Dec. 16 FDLI's distance-learning lecture series will cover the chapters of the best-selling treatise, Food and Drug Law and Regulation. The Dec. 16 presentation is on "Drugs: General Requirements: Jurisdiction, Definitions, Adulteration and Misbranding, Imports and Exports." This series is developed for attorneys, consultants and academics who want to learn about food and drug law in general or clarify understanding of a particular area. Register. Call for sessions: FDLI's 53rd Annual Conference, April 22 and 23 You are invited to submit a proposal for a 1.5-hour, concurrent, breakout session scheduled during FDLI's Annual Conference in Washington, D.C. Your proposal is to include a session title, two- to three-sentence description and proposed participants. Submit your proposal to smg@fdli.org no later than Dec. 18 using the subject line: Call for Sessions. Proposal submission does not guarantee selection. Learn more about FDLI -> About FDLI  |  Join FDLI  |  Conferences  |  Publications Advertising Associate Attorney Manatt, Phelps & Phillips LLP Washington, DC Manager, Commercial Compliance - Auditing Amylin Pharmaceuticals San Diego, CA Health Policy Analyst and Programmer Genentech Washington, DC Sr. Paralegal (Pharmaceutical Contracts/Transactions) Endo Pharmaceuticals Chadds Ford, PA   SmartQuote  Defining and analyzing humor is a pastime of humorless people." --Robert Benchley, American humorist     Subscriber Tools       Print friendly format | Web version | Search past news | Archive | Privacy policy Advertise Account Executive:  Chris Pope 202-737-5500 ext. 295 Download Media Kit Job Board:  Lee Vanderwerff 202-737-5500 ext. 248   Read more at SmartBrief.com A powerful Web site for SmartBrief readers including: Breaking News Industry Home Competitor News Readers' Choice Press Releases Search Archive Who's Hiring? 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