Stimulation and Impedance

Regulatory agencies like the Food and Drug Administration play an important role in any society. Consumers depend on an informed, impartial, and reasonable regulatory agency to protect them from events and contingencies that are beyond their control and expertise. Even the most conservative free-market crusader in the U.S. would most likely choose the FDA-approved slab of beef over a black-market steak brought in from Tijuana.

But even the most left-wing big-government proponent would agree that regulation should not unnecessarily keep much-needed medical products and treatments off the market, a point that became very pronounced during the first days of the AIDS epidemic a few years ago. And everyone would agree that regulation, when it is put in play, must be free of undue interference from individuals and corporations who have a financial interest in that regulation.

And that’s the concern that’s raised in David Griffith’s article (page 1) about the competitive effect of government regulation. No, we’re not suspicious that FDA regulators are on the take from large manufacturers—that role belongs mainly to members of Congress, who disguise their graft in the form of campaign contributions. But regulators need to be more aware that input from a major competitor­—particularly if it’s the only player in a market—is not necessarily completely objective. And the same goes for clinicians who are firmly in the camp of one competitor or another.

Vendors who exploit the slow pace of government approval in order to take advantage of a less competitive environment may enjoy a short-term benefit of increased profits. But in the long term, they will suffer if future product developments in new technologies are delayed because of an atmosphere of suspicion and distrust among manufacturers, clinicians, and regulators.
The best environment for neurotech manufacturers, clinicians, patients, and regulators is one of consistently applied principles and reasoned decision-making. The public won’t object if regulators err on the side of safety—that’s their mandate. But neither should the public accept safety as a guise for failure to perform one’s job in the expected and reasonable amount of time. If waiting an extra six months or a year for a medical product to reach the market does not contribute to the public’s safety, then it detracts from the public’s health.

Consistency and uniformity are also important across national boundaries. In general, neurotech manufacturers have had a much easier time getting CE mark clearance in Europe than FDA approval in the U.S. (see article page 3). Conversely, U.S. manufacturers have often had a harder time getting approval in Japan, for reasons not always relating to safety and efficacy. It wouldn’t be a bad idea for regulators to at least discuss their decisions with counterparts in other countries.

Because neurotechnology is such a new and fast-moving field, it cannot afford to fall victim to political and competitive impediments to product development. It’s in everyone’s interest to work together to create a market that succeeds or fails based on innovation and not on tactics.


James Cavuoto
Editor and Publisher