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December 9, 2008 News for the biotech, medical device, drug and food regulatory profession   Drugs & Biologics    Lawmaker reaffirms support for FDA power over new-drug ads Rep. Henry Waxman, D-Calif., said he plans in January to reopen discussions on giving the FDA authority to prohibit direct-to-consumer ads for new drugs, which may carry risks that are not yet fully understood. Waxman, who is set to become chairman of the House Energy and Commerce Committee next year, said the proposal "makes a great deal of sense and can provide FDA an important tool to protect the public health." Reuters (12/8) Cleveland Clinic expert: FDA must meet act's deadlines The next FDA commissioner should ensure that the agency complies with the Prescription Drug User Fee Act by meeting scheduled deadlines for treatments seeking approval, said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. The delays put "innovative drugs in limbo," Nissen said. BioPharma Today/The Pink Sheet (12/8) FDA questions safety of Acusphere imaging agent Animal tests indicated that Acusphere's Imagify, a contrast agent for improving echocardiogram images, may be linked to hypertension, lower blood pressure and erratic behavior, the FDA said. Acusphere CEO Sherri Oberg clarified that human trials of the injectable product showed no life-endangering side effects and that the risks are similar to those associated with other imaging compounds. A group of outside experts is scheduled to meet Wednesday to evaluate Imagify's efficacy and safety. Google/The Associated Press (12/8), CNNMoney.com/Dow Jones Newswires (12/8) Delay expected for FDA review of Byetta's expanded use Eli Lilly and Co. and Amylin Pharmaceuticals said the FDA may not finish by year's end evaluating their request to market Byetta as a stand-alone treatment for Type 2 diabetes. An Amylin official said the agency has not asked for more trials of the drug, which is cleared as an add-on therapy for managing blood glucose. The Indianapolis Star (12/8), Forbes/The Associated Press (12/8) GSK wins FDA clearance for wider use of Boostrix The FDA granted approval for the use of GlaxoSmithKline's Boostrix -- a vaccine against tetanus, diphtheria and whooping cough -- in adults ages 19 to 64. The decision expands GSK's market for the vaccine, which is cleared as a booster for patients ages 10 to 18. CNNMoney.com/The Associated Press (12/8)   Thought-Provoking Interviews with Medical Device Industry Leaders. Tap into strategic viewpoints of industry pioneers and read candid insights from experienced leaders in the medical device industry! These in-depth, one-on-one interviews with luminaries across the med-tech industry offer insightful perspectives on where the industry is heading. Courtesy of Medical Device Daily – Click here now for FREE access.     Biotechnology  Study reports brain stem cells could restore hearing Scientists found stem cells in the brain's lateral ventricle that have qualities akin to hair cells in the inner ear. The brain cells could be transplanted into a patient's ear, where they could change their function and replace impaired cells to bring back hearing, according to the study. The findings also could prove useful in developing treatments for disorders involving the nervous system, researchers said. Telegraph (London) (12/8)   Food & Dietary Ingredients  China launching a new 4-month food safety campaign China is cracking down on food makers that use illegal or excessive chemicals in their products. Phases will include internal checks, inspections for "high risk" meat and protein-rich products, and targeting producers that make illegal food additives. The Washington Post/The Associated Press (12/8)   Medical Devices  FDA clears vascular stent from C.R. Bard C.R. Bard has secured FDA approval for its E.Luminexx vascular stent, which is designed to treat patients with common or external iliac artery occlusive disease. The company's Bard Peripheral Vascular unit will be in charge of selling the device. Forbes/The Associated Press (12/8) Synthes wins favorable ruling in patent suit Medtronic must pay $7.4 million in a patent-infringement case involving Synthes' ProDisc II, an artificial spinal disc, according to a ruling from a federal court in Memphis, Tenn. A Medtronic spokeswoman said the company intends to appeal the decision. The Commercial Appeal (Memphis, Tenn.) (free registration) (12/9) FDA warns Innovative Neurotronics over contract firm's quality lapses The FDA sent a warning letter to Innovative Neurotronics saying it failed to make sure that its contract manufacturer complied with its quality standards despite complaints and two device recalls. The agency also alleged that the firm did not record design revisions or the measures it took to address reports of defective products. FDAnews (12/8)   FDLI Items  Now Available -- The Essential & Comprehensive Treatise: FDLI's "Food and Drug Law and Regulation" This just released publication is the ultimate and definitive resource on food and drug law. Each chapter includes penetrating analysis and current legal citations, which will expedite your legal research. Written and edited by the most experienced food and drug attorneys in the U.S., "Food and Drug Law and Regulation" is the most complete single volume ever published in this complex field of law. A preview is available online. Purchase your copy today at a special pre-publication rate as quantities are limited! Expected ship date is December 2008. Purchase through FDLI's Web site. Purchase by using FDLI's fax order form. The Food & Drug Law Institute presents its annual Introduction to Food Law and Regulation -- a perfect primer for members of the legal and regulatory affairs communities as well as government representatives During this interactive program, Jan. 27-28, 2009, you will learn the essential elements of food law and regulation while acquiring an orientation to administrative agencies and furthering your understanding of how FDA, USDA and FTC promulgate and enforce regulations. This meeting will provide you with a context for keeping current with emerging issues of concern to food manufacturers, regulators and consumers, such as claims, safety, imports, allergens, advertising and bioterrorism measures. Pending state approval, Continuing Legal Education credits will be awarded. Read more. Register online. Register by fax. Attend this program and Dietary Supplements and receive a $200 discount! Learn more about FDLI -> About FDLI  |  Join FDLI  |  Conferences  |  Publications Associate General Counsel - Regulatory Cardinal Health San Diego, CA Corporate Counsel Genentech South San Francisco Director, Compliance Salix Pharmaceuticals Raleigh, NC   SmartQuote  If you want children to keep their feet on the ground, put some responsibility on their shoulders." --Abigail Van Buren, advice columnist     Subscriber Tools       Print friendly format | Web version | Search past news | Archive | Privacy policy Advertise Account Executive:  Meryl Harold (202) 407-7828 Download Media Kit Job Board:  Celia Rothschild (202) 470-1159   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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