U.S. Approves 35 New Drugs in 2011, Near All Time Record
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The U.S. Food and Drug Administration reported Thursday that it approved drugs in 2011 at nearly the highest rate ever amid criticism the agency has unnecessarily tough requirements and slows innovation and competitiveness.
The FDA said it approved 35 new drugs for the fiscal year ending September 30, a figure only surpassed once in 2009 when 37 drugs were approved. The FDA emphasized that 24 out of those 35 new drugs were accessible to people in the U.S. before they were available anywhere else.
“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” said Margaret Hamburg, M.D., Commissioner of Food and Drugs.
“We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century,” she added.
The FDA said the U.S. is leading the world in first approval of new medicines including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.