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December 6, 2012News for the food and drug law community

  Drugs & Biologics 
  • FDA approves more drugs this year
    Through November, the FDA approved 31 new drugs this year for conditions including rheumatoid arthritis, HIV, multiple sclerosis and cancer, the most since it approved 36 in 2004. For the fiscal year that ended Sept. 30 and using a more inclusive definition of new drugs, the agency said Wednesday that it granted 35 new approvals. The Wall Street Journal (12/5) Email this Story
  • 2 lawmakers unveil bill requiring FDA registration of compounders
    Reps. Rosa DeLauro, D-Conn., and Nita Lowey, D-N.Y., introduced legislation that would mandate registration with the FDA by drug compounders. The Supporting Access to Formulated and Effective Compounded Drugs Act would create an FDA database for use by federal and state regulators in the oversight of compounding pharmacies, but the bill is not expected to be voted on by the end of this session. On Dec. 19, state and FDA officials will meet to discuss states' current authority to regulate compounders. Modern Healthcare (subscription required) (12/5), Reuters (12/5) Email this Story
  • Rules on off-label marketing at stake in appeal of conviction
    A federal appeals court in California will consider today if former InterMune CEO W. Scott Harkonen committed fraud in promoting the lung-disease treatment Actimmune. Harkonen and his attorneys are appealing a wire fraud conviction from 2009 involving the alleged survival benefits of the drug. Conveying a scientific view should be protected by First Amendment free-speech rights, the attorneys said. The Wall Street Journal (12/5) Email this Story
  Global Focus 
  • EU-Canada patent deal will not boost drug costs
    Adopting European patent rules under the Comprehensive Economic and Trade Agreement between Canada and the European Union won't lead to higher public health care costs and higher prices for new drugs in Canada, writes Brett J. Skinner, CEO of the Canadian Health Policy Institute. Critics are advocating that Canada imperil a trade deal with the richest market in the world over unsupported fears about the price of patented medications, Skinner writes. Financial Post (Canada) (12/5) Email this Story
  • EU high court upholds AstraZeneca fine in patent case
    The European Court of Justice refused to lower a $69 million fine against AstraZeneca for allegedly blocking market entry of generic versions of the ulcer treatment Losec. Giving misleading information to national patent agencies is a "serious infringement" commensurate with large fines, the court said. Reuters (12/6) Email this Story
  Food & Dietary Supplements 
  • USDA implements tighter oversight of ground poultry
    The USDA Food Safety and Inspection Service has decided to enforce tighter pathogen controls for raw ground poultry products following two salmonella outbreaks tied to ground turkey in 2011. Makers of raw ground chicken and turkey foods are required to update their pathogen control plans to address possible risks, the FSIS said Wednesday. The FSIS also expanded its salmonella testing program and announced plans to conduct campylobacter screening for ground turkey and chicken. (12/6) Email this Story
  Medical Devices 
  • FDA to hold hearing on contamination of skin prep wipes
    Reducing bacterial contamination of alcohol wipes and other skin prep products will be the subject of an FDA hearing Wednesday and Thursday of next week. "We think a sterile wipe should be used in health care. I'm thrilled that FDA is getting people to the table," said nurse and and epidemiologist Susan Dolan of Children's Hospital Colorado in Aurora. NBC News/Vitals blog (12/5) Email this Story
  • Final IRS rule on 2.3% medical device tax is released
    The Internal Revenue Service has issued final guidance governing the 2.3% medical device tax, which companies are required to pay starting Jan. 1. Some medtech firms, however, are seeking to defer implementation of the tax as part of the fiscal cliff negotiations. A bill that would repeal the tax also cleared the House in June, but it has yet to go through a Senate vote. Reuters (12/6) Email this Story
  • High court may accept review of cigarette warning case
    A federal appellate court denied the FDA's request to reconsider a three-judge panel's opinion in August that voids the use of graphic warnings on cigarette packs, raising the possibility that the Supreme Court may review the case. The appellate court's ruling "was wrong on the science and wrong on the law" because of evidence that advertising and graphic warnings educate consumers about smoking's health risks, motivate smokers to quit and discourage children from smoking, Campaign for Tobacco-Free Kids President Matthew L. Myers said. The Washington Times (12/5) Email this Story
  FDLI Items 
  • Caronia decision to be addressed at enforcement conference next week
    Whether you are a regulator, litigator, compliance specialist or consultant, it is critical to stay current on the changing trends in enforcement, litigation, and compliance. Don't miss this Dec. 12-13 conference. Register. Panel highlights:
    Hot Topics in Enforcement: 2012 Review, 2013 Preview:
    • The Second Circuit decision vacated the conviction of Alfred Caronia for promoting a drug for off-label use on First Amendment grounds. What happens next?
    • FDA's increased use of Warning Letters to foreign manufacturers
    • Recent public health scares and their impact on FDA's regulation of pharmacy compounding
    • The impact of the Pom Wonderful case on the FTC's expectations with regard to substantiation for advertising claims made by FDA-regulated companies
    • Trends in civil enforcement of the Controlled Substances Act regulatory provisions, including case examples
    Email this Story
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Why always 'not yet'? Do flowers in spring say 'not yet'?"
--Norman Douglas,
British writer

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