"I conducted careful reviews of these reports and concluded that both... do not represent rigorous research. ... [T]hey could not survive peer review procedures at serious medical journals and would not be publishable in peer-reviewed publications."
Gregory Curfman, MD
Executive Editor, NEJM [full text]
"[T]he inferences and conclusions that can be reliably drawn from this report are limited"
Howard Bauchner, MD
Editor in Chief, JAMA [full text]
It looks like the cat is finally out of the bag with regard to the November 2010 Makower Report. The report made a splash by claiming an average $24 million cost for a 510(k) and for attempting to demonstrate that approval times in the US exceed those in the EU. Dr. Makower was even invited to testify before Congress based on the publicity around this report.
Although the report contained numerous flaws that were perfectly obvious the day it was published, it provided a compelling set of speaking points to a segment of industry that wants FDA oversight to be drastically reduced. Though it employed little in the way of statistical validation, it was a solid work of emotional validation.
This report deserves every bucket of cold water that's being thrown on it, but we shouldn't rush to discredit the concern it represents. There are many good reasons to seek improvement in the regulatory process and it's going to be a pretty big problem if investors begin to fear this sector. At some level, that should be weighed as a matter of public health too.
That said, grandstanding is a poor way to participate in science policy. This report has had the perverse effect of arguing for making FDA review more unpredictable, not less. As we consider how we approach the agency, let's remember to take a deep breath and think about what we're asking for. Transparency is not always good. Rapid reviews can lead to seriously bad outcomes.
To find the optimal balance between public health and industry innovation, we need to keep reminding ourselves that it's a balance; it's not just about getting everything you want and pushing all other concerns to the side.
Tags: 510(k), CDRH, FDA, Politics, VCs and Investors
