2012 Year in Review: FDA Drug Approvals

CRegal Editor
  • Each year, the U.S. Food and Drug Administration is presented with countless applications for new drugs.  Some of these drugs are brand new formulas, some are being pitched for new purposes, and some are alterations on existing chemical formulas. 


    In the fiscal year for 2012 – October 1, 2011 to September 30, 2012 – the FDA approved 35 new drugs for use.  Of these, 24 were approved for use by the U.S. FDA before any other regulatory agency around the world. 


    Ten drugs were "fast tracked," which allows for a faster review process for medications that are for serious or life-threatening diseases and where the drugs will fit an unmet medical need. 

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    The FDA approval process normally costs hundreds of millions of dollars and can take several years; this fast tracking process was created in 2007 to help advance drugs for life-threatening situations.  The FDA also uses a process of Accelerated Approval, adopted in the early 1990s to account for the fast-moving HIV/AIDS epidemic, though fast tracking is an even quicker mode of approval than the Accelerated Approval process.


    [SLIDESHOW: The FDA Drug Approval Process]

    So, what was new in 2012?

    • 35 novel drugs were developed in fiscal year 2012, meaning that the medicine utilizes new chemical structures and biological products that have never been approved in the U.S. to treat any disease.
    • 10 cancer drugs were approved, including those specifically for late-stage skin cancer, late-stage prostate cancer, myelofibrosis (cancer of the bone marrow), acute and chronic leukemia, late-stage colorectal cancer and late-stage breast cancer.  One drug – Voraxaze – was approved to lower toxic levels of chemotherapy in patients.
    • New drugs were also approved for cystic fibrosis, HIV, meningitis and macular degeneration.  The FDA also signed off on new drugs for the treatment of Alzheimer's disease, relapsing forms of multiple sclerosis, weight management, irritable bowel syndrome, overactive bladder and erectile dysfunction.
    • The FDA also approved the first human cord blood product and the first drugs to treat advanced basal cell carcinoma, a form of the most common type of skin cancer.  The medication for myelofibrosis was also the first drug approved to treat the condition.
    • Two of the new novel drugs show advancements in personalized medicine, which uses genetic and biological information to help identify which patients would best respond to a particular treatment option.


    The drugs approved in 2012 should help explain where pharmaceutical and research dollars are being invested.  Nearly one-third of the new drugs were cancer-related, and this comes after eight (of 30) new drugs were oncology-related in 2011.  The FDA clearly continues to give cancer treatment a high priority, and its many representations have expanded the space in which drugs can be approved.  According to the World Health Organization, among the conditions with the most medicines in development, cancer (878), breast cancer (125), lung cancer (120) and leukemia (119) led the way, followed by Alzheimer's disease and other dementia (89). 


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    The FDA also appears to be investing in approving medications for conditions that have no existing FDA-approved treatments.  The Management Centre Europe, among other organizations, speculates that pharmaceutical companies fear the "patent cliff," and are working to maximize profits within narrow markets, rather than becoming one of many options in a field.  This trend is not necessarily a bad thing, though, as innovative developments are being delivered to patients in need.



    International Federation of Pharmaceutical Manufacturers and Associations. (2012).  "Trends in the pharmaceutical industry and potential impact on future innovation and access to medicines."  World Health Organization.  Retrieved from http://www.who.int/phi/Jenner_Innovation_and_Access_WHO_April2012.pdf.  


    Management Centre Europe.  (2012).  "Trends Impacting the Pharmaceutical Industry."  MCE-AMA.com.  Retrieved from http://www.mce-ama.com/industry-expertise/pharma/trends-impacting-pharma-industry/.


    U.S. Food and Drug Administration.  (December 2012). FY 2012 Innovative Drug Approvals.  Retrieved from http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM330859.pdf


Published On: January 08, 2013