Q: What should we expect from the FDA in the next year?
A: Analysts will be keeping an eye on the number of new drugs approved in 2011 to discern any new trends. As reported by The Wall Street Journal and other publications, the FDA gave 21 drugs the go-ahead in 2010, down from 26 cleared in 2009 and 25 approved in 2008. The dip has concerned some drug industry representatives, who warn that an overly cautious approach could lead to more delays in new drugs reaching patients. Of course, the lower number also could reflect a continued dry spell in the pipelines of many pharmaceutical companies. On the flipside, consumer watchdogs have expressed optimism that the FDA might be devoting more attention to safety. In November, for example, the FDA oversaw the pulling of popular painkiller propoxyphene (marketed as Darvon and Darvocet) after evidence accumulated that the medication can cause potentially fatal heart damage and rhythm abnormalities.
Bryn Nelson is a freelance medical writer based in Seattle.
1. Woodcock J, Sharfstein JM, Hamburg M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med. 2010;363(16):1489-1491.