Yesterday, November 10, 2016, as the last speaker of the morning session during FDA Public Hearing on off-label for pharmaceuticals and medical devices (see http://sco.lt/7UY48X) and, just prior to my approaching the podium, Commissioner of FDA, Dr. Robert Califf noticeably and rather cowardly left the room. The one person who needed to hear what’s wrong with FDA, left the room. Let that sink in for a minute.
As previously written about, the start of the meeting the day prior, was a parade of industry paid shills who dangerously, unethically and illegally lumped together off-label use of pharmaceuticals and medical devices which they conveniently hide behind the First Amendment. The purpose and goal of eight minute talk yesterday was to shame FDA into acknowledging they’ve allowed the industry to illegally misappropriate the First Amendment as it relates specifically to off-label promotion of medical devices. FDA must immediately mandate that all off-label promotion of medical devices are illegal as they are cleared products based on equivalency and not approved products based on fact-based science, and therefore can never be wholly truthful which negates the First Amendment argument misappropriated by the medical device industry.
I’ve often written about the differences between pharmaceuticals and medical devices and as a successful federal whistleblower how I was shocked DOJ & FDA still did not know or recognize the differences. Below is the slide deck provided to FDA and now on record with FDA so that others harmed by medical devices may show this to their attorneys to force accountability from both the industry and FDA.
See slide deck here.