The safety of the people shall be the highest law.
– Marcus Tullius Cicero
Evaluating drug safety is, as I’m sure you know, always an exercise in measuring risks and benefits. One question that can haunt the dreams of companies that market products is “Will the safety profile of my drug be the same after approval as it was in clinical trials?”
A lot of effort goes into making sure that clinical trial populations are representative of the “real world” population that may eventually use the drug. This helps give confidence that the safety profile, not to mention the efficacy, in the trial(s) is predictive of what it will be once marketed. However, it’s impossible to perfectly predict how the drug will be used after approval.
To complicate matters, even if you do manage to reasonably mirror the real world population and usage, there may be rare effects that aren’t detected until a significantly larger number of people are exposed to the drug, or until people are exposed to the drug for longer than is feasible in trials, or both.
Enter post-marketing surveillance, the importance of which is self-evident. To help disseminate safety information for marketed products in a reasonably rapid way, the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) required that the FDA perform safety analyses of recently approved products and prepare summaries of the analyses. These summaries must be prepared within 18 months of product’s approval or after 10,000 patients have used it, whichever comes second.
The FDA recently announced that these safety summaries will be posted on its website along with comments on how to address safety concerns if applicable. As of this writing, you can find safety summaries for 26 products approved in 2008 on the site. The FDA also has provided answers to some questions about its plan to post safety summaries here.
Now, these summaries don’t include hard data on number of people using a drug compared to how many safety signals were seen, but hopefully they will be enough to provide a useful preview of the FDA’s current thoughts on a drug to medical professionals and the general public.
