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Washington Wrap-Up |
A new report and epic January enforcement activity demonstrate the Agency’s fearlessness in 2013.
In January, CDRH moved with impressive─and unusual─speed against a number of alleged violators (see the following stories). As CDRH uped its game, the Greenleaf Health consultancy released an analysis of compliance and enforcement for the agency. The group plotted an Obama-era surge in four areas of CDRH enforcement: inspections, FDA-483 observations, Warning Letters, and product recalls.
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| A lion, mid-roar. Photo by Jason Hall via Wikimedia Commons. |
Led by former FDA associate commissioner for regulatory affairs Michael Chappell, this $99 report found almost a 40% increase in CDRH inspections since 2008, almost 30% more Warning Letters to medical device companies, and more than a 250% increase in device recalls since 2007.
FDA commissioner, Margaret Hamburg, did not specifically single out the device industry for increased attention, but she did order a more vigorous agency-wide effort on compliance and enforcement, and Greenleaf’s analyses clearly show that on most measures CDRH has more than kept pace ─ something it was not doing before.
While clear-eyed objectivity is supposed to be the demeanor of a regulatory health and safety agency, since the Reagan administration, signs of increasing politicization have been observed at FDA as well as other agencies. Ideological budgetary measures up or down have been a popular political tool, in addition to the placement of politically correct key managers.
At FDA, decades of budgetary restraints have curbed compliance and enforcement zeal, nowhere more noticeably than at CDRH. The change at CDRH since Obama’s presidency is palpable.
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An accusation
I'm a great fan of the CDRH agenda in rules and enforcement -- they focus on the product development and its lifetime rather than a single model. (As do every international standard as well). They know that if a blue tongue depressor has a problem with safety or effectiveness, the red one probably does too, so they see if the paperwork and the underlying processes are in order. If they were a simple enforcement cop, only the blue production line would be shut down, but since they are development partners they can take action on an entire plant.
The blatant accusation in the article is that previous employees of the FDA were influenced by politics (and I guess the regulated), and the uptick in enforcement activity is a sign the new folks are "honest". That is a very serious accusation -- I would certainly like to see something other than raw statistics in a $99 report to point fingers at an industry, the regulators and our elected representatives. I'm listening. Do we have evidence of previous lax enforcement?
My worry is that the enforcers will get so tied up in the spectacular device recalls that they forget that their best weapon to protect Americans by far is to insure both Safety and Effectiveness considerations are paramount from the first minute an idea is formed until the last product goes out of use. And written down.
(A personal opinion, not of any organization)
Empty roaring ...
It is about time!
Either mean what you say or stop wasting our time with idle threats… and get the politics out of public health!
GM Samaras Pueblo, CO