Who Needs A Side Effect Report System, Anyway?
4 CommentsBy Ed Silverman // November 30th, 2011 // 9:59 am
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.
Anne PME
I could ask the troop leader of a boy scout troop if the boy scouts would be interested in developing and ADE reporting system as a merit badge project. I would probably indicate to the troop leader that due to apparent reading comprehension and squenticial processing issues on the part of certain Crescendo agents, the ADE system would need to be accessible to people with ADHD.
AMC
How are they sure they did not have ADEs since they had no system for tracking or reporting them?
dsd
Seems like Crescendo Therapeutics didn’t want to bother with much- like submitting an ANDA for Hybrisil, even though it looks like a prescription medication. From what i can see on Drugs@ FDA Hybrisil is a unique route of administration for methylprednisolone acetate- topicals listed, including Hybrisil. So with no marketing approval for a novel therapeutic with no proven safety and efficacy, lacking a written PADE seems to be the least of the opps! omissions. Unreal. How is this even possible? Am I missing something?
Searching2000
@DSD:
Let me try to put his gently - if you have to ask “How is this even possible?” - you don’t get out much.
Or you don’t get called “afterwards” into large non-compliance events where the ususal question, as documents are reviewed and explanations are parsed is “What were they thinking?” And the usual conclusion is - “They weren’t”