Possible Reasons For Five-Year Low Of FDA Drug

Armen Hareyan's picture
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USA Today on Monday examined how somepharmaceutical industry analysts cite "more cautious regulators and lessinnovation by drug makers" as reasons for the low rate of new drugapprovals in 2007 (Schmit, USA Today,2/4). FDA in 2007 approved 19 new medications -- 17"new molecular entities" and two biotechnology medications -- adecrease from 22 in 2006 and the lowest number since 1983, when the agencyapproved 14 new treatments (Kaiser DailyHealth Policy Report, 1/10). The agency also approved 65 newdrug applications, or 64% of the applications it received, down from 73% in2006, 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 whoserisks were found to outweigh their benefits after they went on themarket," such as Vioxx and Bextra, USA Today reports. Inaddition, Linda Bannister, a health care analyst at Edward Jones, said she believes FDA may be less likely toapprove medications that do not show a clear benefit over older versions ofsimilar drugs and that might carry unknown risks. Meanwhile, Ira Loss of theresearch firm Washington Analysis said that the industry's"research drought" has led to weakened drug applications and fewerapprovals. Loss said the number of new drug discoveries peaked in the mid-1990sand then "petered out."

FDA spokesperson Christopher DeFrancesco said the agency's approval standardsfor new drug submissions have remained the same, adding that the rate ofapprovals to submissions has stayed consistent at about 80% between 1997 and2005 (USA Today, 2/4).

Reprintedwith permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign upfor email delivery at kaisernetwork.org/email . The Kaiser Daily Health PolicyReport is published for kaisernetwork.org, a free service of The Henry J.Kaiser Family Foundation.

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