An opinion piece in a recent Wall Street Journal by Dr. Scott Gottlieb, who was Deputy Commissioner of the FDA ten years ago (how time flies!), and Coleen Klasmeier, an attorney specializing in FDA matters, accuse the agency of throwing its vast regulatory weight around, effectively chilling the development of newer, better apps for personal devices (smartphones).
Cleverly titled, Why Your Phone Isn t as Smart as It Could Be, the authors wonder why devices with simple tasks such as recording and storing physiological data heart rate, blood sugar levels need to be addressed at the same level of regulatory oversight as, say, heart valves or artificial joints. They point to the FDA s trend toward issuing guidances rather than formal rules, and inviting innovators and marketers to come in and talk with us which is often a harbinger of lengthy waits for final approvals, or (more likely) not-quite-final approvable guides requiring more information, including lengthy and expensive studies. They quote Google s co-founder S. Brin: "Health is just so heavily regulated." The effect on innovation is obvious: how can millions be invested in beneficial advances in technology when the fear of an FDA premarket review request for years more data will send the investment down the drain?
The nugget of their argument is here: The ambiguity created by the guidance and the agency's premarket review processes forces innovators to seek the FDA's nod for every new launch and every small advance. This slows progress to a crawl. Worse, the lag may be almost entirely unnecessary, as most of these products are not properly regarded as a medical device in the first place.
ACSH s Dr. Gil Ross had this perspective: As night follows day, the old dictum remains valid: Regulators regulate. That s what they do. And power corrupts (enough maxims now). To the FDA, every advance looks suspiciously like a health threat until proven otherwise and proving the absence of a threat is devilishly hard, and expensive. To digress only slightly: I feel that on this day the deadline for filing comments on the FDA s deeming regulations for e-cigarettes I d be remiss if I failed to note the analogy between the personal-device apps concerns voiced by Dr. Gottlieb and Ms. Klasmeier, and the chilling, dead-hand effect of those regulations upon the currently vibrant and public-health benefitting e-cig/vapor industry. I often wonder if there is no way to rein in the hyper-precautionary edicts and requirements of this rogue agency, at last?