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 thats the concern thats raised in David Griffiths
article (page 1) about the competitive effect of government regulation.
No, were not suspicious that FDA regulators are on the take
from large manufacturersthat 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 competitorparticularly
if its the only player in a marketis 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 wont object if regulators err
on the side of safetythats their mandate. But neither
should the public accept safety as a guise for failure to perform
ones 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 publics safety, then
it detracts from the publics 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 wouldnt 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. Its in everyones interest to
work together to create a market that succeeds or fails based on
innovation and not on tactics.
Editor and Publisher