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January 31, 2013 News for the food and drug law community   Drugs & Biologics  FDA grants fast-track status to GI ARS drug by Soligenix Soligenix's OrbeShield obtained fast-track designation from the FDA as treatment for gastrointestinal acute radiation syndrome. The drug has already won orphan-drug status to prevent death after a lethal or high dose of irradiation from a disaster. Pharmaceutical Business Review Online (1/31) Advisers recommend FDA reject Pharmaxis' CF drug Bronchitol The FDA Pulmonary-Allergy Drugs Advisory Committee voted 14-0 to recommend against approving Pharmaxis' cystic fibrosis drug Bronchitol, or inhaled mannitol, because of concerns over the drug's efficacy and safety in pediatric patients. Panelists cited a higher risk of hemoptysis in children as well as concerns about the evidence for efficacy. MedPage Today (free registration) (1/30) Feds warn Flu and Cold Defense for marketing untested flu drug Flu and Cold Defense received a warning from the Federal Trade Commission and the FDA for what the agencies said were misleading claims about its inhaler GermBullet. The product hasn't been approved as safe and effective, the regulators said. American City Business Journals/South Florida (1/30), Las Vegas Sun/The Associated Press (1/30) Panel doubts agents' role in improving Alzheimer's diagnosis The Medicare Evidence Development & Coverage Advisory Committee showed a lack of confidence in the use of imaging agents to detect brain plaques linked to Alzheimer's disease risk. Only one of the 12 voting members expressed intermediate to high confidence that the agents will help improve outcomes in patients showing early signs of memory problems. This lack of confidence may lead to CMS reimbursement problems for Eli Lilly & Co.'s FDA-approved imaging agent Amyvid. Lilly said it is confident of the usefulness of its product in evaluating patients suspected of having Alzheimer's. Reuters (1/30) Earlier challenges will curb patent settlements Allowing an opposition proceeding sooner could eliminate low-quality drug patents early in an inexpensive and relatively fast proceeding, writes Alfred Engelberg, former patent counsel of the Generic Pharmaceutical Association. The growth of the generic drug industry has rendered many of the provisions of 1984's Hatch-Waxman Act unnecessary, and change is needed to end a system of patent settlements and low-quality patents that stifle competition, Engelberg writes. Politico (Washington, D.C.) (1/30)     Global Focus  India says compulsory license for Nexavar doesn't violate trade pacts India didn't violate multilateral trade agreements by granting a compulsory license for Bayer's cancer treatment Nexavar in order to make it cheaper, Indian Commerce and Industry Minister Anand Sharma told U.S. Economic Growth, Energy and Environment Undersecretary Robert Hormats. An official said that Hormats raised the issue and said patent holders need to know the action will not become routine. The Hindu (India)/Press Trust of India (1/31)   Food & Dietary Supplements  Veal producer pulls products due to E. coli risk San Jose Veal announced its decision to recall 1,260 pounds of veal trimmings due to E. coli O157:H7 contamination. Affected products, which were produced from Nov. 1 to 9. FoodSafetyNews.com (1/30)   Medical Devices  Eucomed comments on EU medtech scrutiny in position paper Eucomed calls the scrutiny procedures in the European Commission's proposed regulation of medical devices "inappropriate," saying the regulation will not help ensure device safety and will instead create a false sense of security while duplicating regulatory efforts and creating financial burdens for new companies. The proposal would create a Medical Device Co-ordination Group to review products and clinical trial evidence. Eucomed advocates an alternative "systematic authority control procedure on notified bodies and clinical review that go beyond the current proposed measures," including measures to keep stakeholders involved in the process. Clinica (subscription required) (1/31) CMS coverage guidance draws medtech, drug industry concerns Draft guidance released by CMS in November on the use of coverage with evidence development (CED) for determining Medicare coverage elicited industry concerns. The guidance suggests available data used to obtain FDA OKs "will rarely be sufficient for Medicare coverage," creating more confusion on the use of CED, said Chandra Branham of the Advanced Medical Technology Association. Bloomberg BNA (free content)/Pharmaceutical Law & Industry Report (1/30)   Tobacco  Utah Senate OKs bill that would tax cigarettes made by rolling machines A bill that would close a loophole in the cigarette tax in Utah was passed by the Senate and sent to the House. The bill would impose taxes on cigarettes created by rolling machines that can produce 150 cigarettes in less than half an hour. The Salt Lake Tribune (Utah) (1/30)   FDLI Items  Cosmetics Regulatory Process Primer -- Instant access, purchase and download now The Cosmetics Regulatory Process primer provides a baseline of key legal concepts and issues from experts in the field; describing, in detail, the basis of the underlying standards governing cosmetics and how cosmetic oversight differs from the regulation of food, drugs or medical devices. With this basic guide, readers will develop a firm grasp of the legal and regulatory concepts for cosmetics. Other available primers include: The Medical Device Review Process: A Focus on Pre-Market Requirements Controlled Substances: FDA and DEA Regulation of Pharmaceuticals Pharmacy Compounding -- Join the discussion on Feb. 12 – Panel highlight With newly proposed legislation, the courts split and statutory authority at issue, this is the ideal time for stakeholders to convene, communicate, and explore "what's next" in compounding oversight. Join FDLI for our upcoming program -- Pharmacy Compounding: An FDLI Dialogue-- on Feb. 12 in Washington, D.C. During the first panel, Regulation of Pharmacy Compounding: Historical Analysis, panelists will lead an interactive discussion on the historical framework of the regulation of pharmacy compounding. Panelists include: Douglas B. Farquhar, director, Hymann, Phelps & McNamara P.C. Casey Kozlowski, R.Ph., M.B.A., director, retail ancillary services, Walgreen Co. William A. 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