I did a tally of MedWatch alerts for the century. The table below only reflects those issued for CBER and CDER and does not take into account alerts issued about devices or supplements. The interesting thing is the scale and the erratic patterns. For example, in 2000, biologics accounted for about 45% of those 58 alerts.
|
Year |
CDER and CBER combined |
|
2006 |
63 |
|
2005 |
115 |
|
2004 |
51 |
|
2003 |
36 |
|
2002 |
43 |
|
2001 |
45 |
|
2000 |
58 |
But in the other years, biologics accounted for less than 20% of the alerts. I’m not suggesting that 2000 was an anomaly premised on something unusual going on with biologics, but the pattern of alerts and the sudden uptake in 2005 seems to indicate a sort of arbitrary approach to the whole issue.
A key to restoring public confidence is consistency. These figures are not particularly consistent. There might be an explanation, but the FDA should explain how and when MedWatch alerts are issued, and why this pattern makes sense, to reinforce public confidence.
