Health Law Advisor

This post was co-authored by David Schwartz, CEO and Co-Founder at Ethics Through Analytics, and Michael Shumpert, Data Science Executive at Mosaic Data Science.

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted[1] our April FOIA request in which we asked the agency to add back demographic data fields that it had previously removed from its public Medical Device Report (“MDRs”) databases. To find potential bias, we encourage manufacturers to use this data to look for any disproportionate impact its ...

Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look at the data. While we can both claim some evidence in support of our respective theses based on the analysis, Brad must admit that Colleen’s thesis that MDRs tend to lag recalls has the stronger evidence. We are no longer friends. At the same time, the actual data didn’t really fit either of our predictions well, so we decided to invite James onto the team to help us figure out what was really going on. He has the unfair advantage of not having made any prior predictions, so he doesn’t have any position he needs to defend.

While this column typically uses data visualizations you’ve probably seen before, I want to introduce one that perhaps you have not.  This is in the realm of text analysis.  When looking at FDA data, there are numerous places where the most interesting information is not in a data field that can be easily quantified, but rather in narrative text.  Take, for example, Medical Device Reports of adverse events, or “MDRs.”  While we can do statistical analysis of MDRs showing, for example, which product categories have the most, the really interesting information is in the descriptions ...

Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants.

The March 26, 2019, meeting of the General and Plastic Surgery Devices Panel was convened to discuss issues and concerns related to the benefit-risk ...