Are drugs suddenly riskier or is the FDA suddenly more vigilant? Questions about the agency’s efficacy in protecting public health began to increase a few years back, when the ephedra issue presented itself and many critics thought that the agency moved so slowly to react that it looked like a follower, not a leader. One signal that the agency takes this criticism seriously and reacts by increasing visible vigilance is looking at the issuance of FDA Medwatch alerts.
Since 2003, there has been a notable increase of 200% in output from the agency and nearly doubling the rate since last year.
In 2003 there were 108 MedWatch alerts.
In 2004 there were 160 MedWatch alerts.
In 2005 there were 300 MedWatch alerts.
Are drugs riskier or the agency more vigilant? Or is there another reason for this increase? Perhaps, but look for other visible surrogates that signal that the agency is appearing proactive rather than reactive.