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December 6, 2012
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News for the PBM Industry

  Featured Story 
  • 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) LinkedInFacebookTwitterEmail this Story
 Registration is now open for PCMA's Managed Markets Educational Forum!
Whether you are a seasoned managed markets executive or someone who supports the team, PCMA's Managed Markets Educational Forum will provide valuable education on fundamental, as well as complex and strategic issues relevant to professionals of all levels within pharma managed markets or market access divisions. Visit PCMA's website to learn more about our 2013 events!
 

  Legislative & Regulatory News 
  • FDA expresses confidence in reviews of generic drugs
    The FDA's approval process for generic drugs, including approvals based on extrapolated data, is safe and reliable, Center for Drug Evaluation and Research Director Dr. Janet Woodcock and other FDA officials wrote in an article in the New England Journal of Medicine. The agency withdrew approval for 300-mg bupropion after finding it did not perform similarly to the brand-name version of the same dose. The drug was approved based on extrapolation of bioequivalence data from the 150-mg dose. Medscape (free registration) (12/5) LinkedInFacebookTwitterEmail this Story
  Drug Industry Spotlight 
  • 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) LinkedInFacebookTwitterEmail this Story
  • 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 under a more inclusive definition of new drugs, the agency said Wednesday that it granted 35 new approvals. The Wall Street Journal (12/5) LinkedInFacebookTwitterEmail this Story
  SmartQuote 
To change one's life: Start immediately. Do it flamboyantly. No exceptions."
--William James,
American psychologist and philosopher


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About PCMA
PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 210 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.

 
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