To start out with, the FDA has a very difficult role, as
you've pointed out.
However, the delays forced by the system
pose a greater danger to public health
than might be
thought.
The problem is that the FDA is turning into the
TSA of
the medical industry. In her official
bio, the Commissioner is quoted as saying,
"A strong FDA is an agency that
the American public can
count on."
While I would be the first to admit
there are certain
safeguards necessary to prevent gross negligence, it seems
the courts have that one pretty well tied up. Get sued for
gross negligence,
and you're in big trouble. No need for the
FDA to be involved at all. Is the
FDA involved in medical
malpractice? Nope, that's handled by the
courts.
We're seeing an increase of cases where the FDA is
dealing with
conflict of interest. Officials should recuse
themselves if they have any
connections to a company whose
products they are evaluating. Including if
they've ever
gotten a research grant from them, if a relative works
there,
etc. And let's put it under the judicial branch.
Create a special court system
that evaluates violations of
public safety rather than forcing innovators to
prove that
their products are safe before bringing them to market.
That
would encourage legitimate innovators, while
punishing those who do not follow
industry guidelines. Sure,
it would hand it over to the lawyers and their fees,
but it
would be much better than having an opaque and autocratic
agency that
flexes its muscle just because it can.
Disclosure: I've worked in the
medical device industry,
primarily in product marketing, and was also involved
with
new product development. --- IANAL
Linguist and Open Source Developer [ Reply to This | Parent | # ]
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