FDA’s Device Program Really is in Crisis
In July, a subcommittee of FDA’s Science Board released a cleared-eyed 37-page report on what it called the “financial and strategic threats” confronting CDRH’s regulatory science and engineering programs.
Composed of seven academic and industry outsiders, the subcommittee could say things no FDA employee would be allowed by political considerations to say.
Foremost among these was the warning that politically imposed loss of federal investment in CDRH regulatory science “will interfere with the regulatory approval of emerging technologies and in doing so cost lives.” It noted that the device industry is “setting record pace in advancing life-saving technology” and that FDA’s primary pressing need is to fund a “robust and successful CDRH science program.”
I’ll admit to being among those who have been highly skeptical of commissioner Margaret Hamburg’s constant harping about the importance of regulatory science. That skepticism was largely fueled by her inability to clearly define the term when I asked, soon after she came aboard, about its application to field enforcement.
Perhaps the concept was still less than half-baked at the time.
Anywa...
