USA Today Examines Possible Reasons For Five-Year Low Of FDA Drug Approval Rate

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 Feb 2008 - 11:00 PDT

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USA Today on Monday examined how some pharmaceutical industry analysts cite "more cautious regulators and less innovation by drug makers" as reasons for the low rate of new drug approvals in 2007 (Schmit, USA Today, 2/4). FDA in 2007 approved 19 new medications -- 17 "new molecular entities" and two biotechnology medications -- a decrease from 22 in 2006 and the lowest number since 1983, when the agency approved 14 new treatments (Kaiser Daily Health Policy Report, 1/10). The agency also approved 65 new drug applications, or 64% of the applications it received, down from 73% in 2006, according to data released by BioMed Tracker.

Some industry analysts say FDA is being more careful in granting approvals "after drawing criticism in recent years for approving some drugs whose risks were found to outweigh their benefits after they went on the market," such as Vioxx and Bextra, USA Today reports. In addition, Linda Bannister, a health care analyst at Edward Jones, said she believes FDA may be less likely to approve medications that do not show a clear benefit over older versions of similar drugs and that might carry unknown risks. Meanwhile, Ira Loss of the research firm Washington Analysis said that the industry's "research drought" has led to weakened drug applications and fewer approvals. Loss said the number of new drug discoveries peaked in the mid-1990s and then "petered out."

FDA spokesperson Christopher DeFrancesco said the agency's approval standards for new drug submissions have remained the same, adding that the rate of approvals to submissions has stayed consistent at about 80% between 1997 and 2005 (USA Today, 2/4).

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