If you read this blog, you probably follow the world of drug safety closely. So I’m sure you saw the JAMA article, and the resulting coverage by the main stream media, that was authored by Downing, et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.
If you haven’t had a chance to read the study yet, the results demonstrated that a third of every drug approved from 2001-2010 was subject to post-marketing action by FDA. Even more alarming was the finding that drugs with accelerated approval by FDA during this period were twice as likely to be subject to label changes or warnings after approval.
Several media outlets noted that these findings are particularly timely since Dr. Scott Gottlieb, the recently confirmed new head of FDA, is pushing for more accelerated drug approvals. And, in short, more accelerated approvals = more safety issues in the real world.
When we first launched our enterprise platform back in 2014, our goal was simple - to help clients understand and mitigate the risk of post-marketing side effects. It was a simple goal, but it proved to be a difficult task. The vision to combine disparate datasets to aid in drug safety decision making came not only with technical challenges, but also questions around product-market fit.
When developing our go-to-market strategy, we identified an information gap that existed between pharma and their customers. Decisions were being made without access to all of the data. We built our business filling that gap and we’re proud of the long-term relationships we’ve developed and the impactful decisions our data, analytics, and insight have helped to shape. This recent study is validation to our clients who understood the inherent market risks and how our platform could help to mitigate those risks.
After several pharmacovigilance focused conferences and countless conversations in the first five months of 2017, I am happy to repeat that the pharmacovigilance industry has changed since those early days. Pharmacovigilance 2.0 has arrived. Legacy platforms and dated informatics practices are being replaced with agile, flexible, and scalable systems that take advantage of public’s knowledge that approval does not equal safe, to further investment in and expand on pharmacovigilance capabilities.
Continuous monitoring and post-marketing surveillance is, and will continue to be more important than ever. We look forward to continuing to work with our clients in managed care, health economics and outcomes, pharmacovigilance, and other organizations whose goals are to understand and mitigate drug safety risk, on advancing the science and practice of pharmacovigilance, and bringing drug safety to the next level.
Do not hesitate to contact us if you’d like to discuss pharmacovigilance 2.0 and its impact on managed care, HEOR, or Drug Safety.