Scott Gottlieb (physician) and Coleen Klasmeier (attorney) have penned an excellent op-ed piece in the Wall Street Journal that tasks the FDA for their unbending regulatory caprice and unwillingness to adapt to the new advances in medicine. It is definitely in line with what Centeno has been saying for these long years. Read it here.
They are reasonable troubled by the DC court’s uncritical acceptance of the FDA’s arguments and note:
“The FDA has repeatedly sought to blur the line between manufacturing medical products and practicing medicine whenever new techniques emerge. But the standard for regulation isn’t whether the agency feels a technique is novel but whether it meets the definition of being a medical product.
Federal regulators have stretched that definition to the point where a reasonable limit no longer exists. The law provided a clear impediment to unrestrained exercise of FDA authority. Something needed to be an “article”—not a medical procedure—in order to become a drug. The constraint that a drug needed to be a “thing” has been read out of the law by FDA, and the district court appears to have accepted that position.
If the FDA’s victory is upheld on appeal, then conceivably nothing done as part of clinical practice is beyond the agency’s reach.”
They also sadly note: “Most of the science of using adult stem cells for regenerative medicine is unfolding in Britain, Singapore and Israel precisely because of the FDA’s bent to hold with misgiving anything novel in medicine.” Reform the FDA. To do that we need a new president.
Beyond the Dish 