Another week, another safety alert from the FDA. According to the Washington Post, the agency has issued 14 advisories since early November, leading one Wall Street analyst to suggest a color-coding system a la the Department of Homeland Security--so that we can all know instantly just how serious the risk might be.
The agency confirms that the seeming uptick in alerts isn't our imagination. It's communicating concerns to the public more quickly these days; one official said the regular early warnings are fulfilling a promise from HHS Secretary Mike Leavitt to tell the public sooner about adverse drug reactions. And perpetual FDA critics such as Rep. John Dingell call the increase in activity "a quantum improvement."
The Post goes on to detail the different sorts of warnings and give examples of each. But in picking up the story, the Eye on FDA blog did a little due diligence and found a different angle. FDA MedWatch Alerts did increase--from 2003 to 2005. In 2003, there were 108; in 2005, 300. But in 2006 the number dropped to 120, and in 2007 barely grew, to 157. So far in 2008, the FDA has issued only 19 MedWatch alerts. That is indeed more than one a week. But at the going rate, we'll end the year at only around 145.
- see the report from the Washington Post
- read the follow-up at Eye on FDA
ALSO: RPM Report is predicting--or perhaps just speculating--that the FDA is gearing up for a significant crackdown on drug investigators. Report