Pharmacovigilance Grows in Importance

Post-marketing drug safety studies used to be easy to conduct and even easier to avoid. That's over. From now on a drug company will find it very hard to ignore how patients are responding to their drugs, and adverse events will be widely publicized. First, the FDA will require it. Second, it's getting easier to do. As big, national managed care organizations like UnitedHealthcare gather millions of Americans into their plans, it will become much easier to perform the kind of data mining operations that will deliver a much clearer picture of drug safety.

That means higher costs to maintain a drug on the market but a better reputation for safety. Given the ongoing debacle of Vioxx and the spectacle of scientists being forced to explain why essential data was being pushed out of sight, a commitment to safety is just what the doctor ordered.