We Don’t Need No Stinking Side Effects Reporting System!

We Don’t Need No Stinking Side Effects Reporting System!

December 1st, 2011 // 1:27 pm @

So here is an interesting way to interpret FDA regs – if no adverse events are reported for your drug, why bother instituting procedures for tracking and reporting any side effects? This may not make sense to everyone, but that was apparently the rule of thumb that was followed by Crescendo Therapeutics, which sells HybriSil, a topical treatment for scars.

The FDA, however, took exception. During an inspection last April, the agency noticed that Crescendo was violating Post-Marketing Adverse Drug Experience regulations, known as PADE, since the drugmaker did not have any written procedures for the “surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA.” There were none, specifically, for HybriSil, according to a November 17 warning letter.

But why not? During the inspection, the FDA inspector asked Crescendo management about this oversight and was told that the drugmaker had, “so far,” not received any quality complaints or adverse drug experiences. In other words, if no one is complaining – or perceived to have a real problem – why bother with the dirty work of creating an adverse event reporting system?

Of course, this theory can only go so far. What if, one day, a crescendo – pun intended – of side effects roll in? As the Boy Scouts say, be prepared. But there is more. In response to a 483 inspection report that was issued, Crescendo wrote to the FDA to say that a “finalized, written procedure” was created, but then failed to submit a copy. Maybe it was just too much trouble.


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