
The F.D.A.’s Medical Device Problem - sethbannon
http://www.nytimes.com/2015/07/17/opinion/the-fdas-medical-device-problem.html
======
crisnoble
As an insulin dependent diabetic I am consistently frustrated at how slow the
medical device approval market moves. There is a reason that the most advanced
insulin pump that I can buy 2015[0] looks like a pager from 1998, and it is
not because the companies are moving too fast. I have been told that the
reason all of the supporting software is so outdated is also because they are
handcuffed by the FDA approval processes.

I can see the author's point of view, but this is a rare case (for me
personally) that I am not in support of more government oversight.

[0] [http://www.medtronicdiabetes.com/treatment-and-
products/mini...](http://www.medtronicdiabetes.com/treatment-and-
products/minimed-530g-diabetes-system-with-enlite)

~~~
tolmasky
_> I can see the author's point of view, but this is a rare case (for me
personally) that I am not in support of more government oversight._

This seems to be a trend, when people know about a certain field well, they
are against the government oversight of it. The issue of course is that people
are usually intimately familiar with maybe ONE field, but get an opinion on
everything, and thus are very cautious of all the things they don't know
anything about.

Software people understand the problems with "making encryption illegal",
regular people don't and are more willing to hear the high level "safety
issues" of letting hackers hide their information.

You are well aware of the issues with these devices, most people aren't and
are more willing to hear the high level "safety issues" of letting any ol'
device get into the hands of consumers.

Scientists know about all the potential benefits of stem cell research, most
people without biology degrees are more willing to hear the high level "safety
issues" of the frankenstein stories we're sold.

~~~
Fomite
I'm an epidemiologist, I've with post-licensure trial data, and I'm pretty for
government oversight.

Because we have the "nutritional supplement" market as a working example of
"We give people stuff without bothering to see if any of it actually works".

~~~
nostromo
I use a supplement regularly (melatonin) and I'm happy the FDA isn't involved.

What pharmaceutical company is going to bother getting FDA approval for an
already-patented substance that is dirt cheap and readily available?

In the EU, melatonin is regulated and requires a prescription -- which seems
to me to be an unnecessary cost and hassle.

~~~
pdabbadabba
Why not the company that makes the melatonin you are currently taking?

Presumably they are making a profit at it. They spent a bunch of money to set
up factories to produce, package, and market melatonin, why suppose that FDA
approval, but not these hurdles, would stop them?

Or what about the patent-holder (if there is one)? One would think they would
have _ample_ incentive to seek FDA approval if they have a temporary monopoly
on producing the compound.

~~~
tolmasky
_> Presumably they are making a profit at it. They spent a bunch of money to
set up factories to produce, package, and market melatonin, why suppose that
FDA approval, but not these hurdles, would stop them?_

Clearly more hurdles are... more hurdles?

~~~
pdabbadabba
Hard to argue with that logic, of course. But I don't see how this observation
is relevant to the question I posed: why we should think that _this_ hurdle,
but not the many others that exist today, would stop people from selling
melatonin, as nostromo suggested it would. (As opposed to merely making it
marginally more difficult which, of course, is undeniable.) Or, perhaps more
to the point, why this particular hurdle is not worth the supposed consumer
protection benefits of FDA regulation? (Primarily: ensuring that products
marketed as having therapeutic value actually do, and that these benefits are
not outweighed by dangerous side-effects.)

~~~
tolmasky
_> Hard to argue with that logic, of course. But I don't see how this
observation is relevant to the question I posed: why we should think that this
hurdle, but not the many others that exist today, would stop people from
selling melatonin, as nostromo suggested it would. (As opposed to merely
making it marginally more difficult which, of course, is undeniable.)_

I guess I just don't see how this question isn't a tautology. No one is
arguing that the other hurdles couldn't stop it either. But if the
manufacturing costs are $1 million, and the FDA costs are $1 million, then I
don't see how it isn't obvious that needing BOTH is $2 million and thus MUCH
more difficult. I agree that if we could magically reduce manufacturing costs
to zero it would be even better. But your argument literally seems to be
"since this is already expensive and difficult, we can make it arbitrarily
more expensive and difficult with no reduction in success rate". Which
obviously isn't true. More to the point: we _know_ that it can get through the
manufacturing hurdles because _it did_. We thus know this company is capable
of 1x costs. Had they ALSO had additional costs from the FDA then it would
have been >1x costs and thus we _don 't know_ if they would have succeeded.

Perhaps an analogy. Let's say someone proposed a new fee for graduating
college of $50,000. I would say "well, that might make it so less people can
graduate, since it'll cost more". Then you might respond "But what makes you
think THIS cost will prevent them, and not the existing expensive tuition?".
Well, both do, but they already pay one and we're in control of a theoretical
second one.

 _> Or, perhaps more to the point, why this particular hurdle is not worth the
supposed consumer protection benefits of FDA regulation?_

This on the other hand is a completely reasonable question, but _not_ more to
the point, just a a _compeletely_ different point than "the company already
has costs, what is the problem with more costs?"

------
icegreentea
We were just talking about something like this this morning. My company makes
diagnostic devices for hospital settings, and we were bitching about the lack
of a middle road for introducing changes to devices. To somewhat oversimplify,
either the change doesn't effect the function of the product, and in which
case internal testing and documentation is all that is required, or it does
'effect the function' of the product, and you have to redo the entire 510k
process - which is a crap load of money and time and effort.

The result is that sometimes you end up releasing a suboptimal product, and
NOW YOU CAN'T IMPROVE IT. Having some sort of intermediate level of
testing/approval seems like it would be incredibly beneficial.

That said, I'm obviously biased given all the frustrations I've been running
into at work.

Another thing that's super annoying is that the guidance document for weather
or not a change requires a new 510k is woefully out of date and hilariously
vague. It's from 1994 I think (so it doesn't deal with the concept of software
very well), and the last time they tried to update it, they made it so
specific that it got shouted down while in draft form.

The specific issue here is that the vagueness and lack of guidance severely
penalizes small players. Larger players both have the experience and
connections to navigate the rules, and also have the financial resources to
absorb the losses when they gamble and lose.

I honestly think that this is a net lose for everyone, both in terms of health
outcomes, and total cost.

~~~
seehafer
So much of what the House is trying to do here could be accomplished by making
the FDA actually make some real guidelines and _stick to them_.

Like you say, deciding whether not change X is a memo to file, a special,
abbreviated, or full 510(k) is pretty much black magic because of how vague
FDA is, so it basically comes down what your Regulatory VP is willing to live
with, politically, inside the company.

"The specific issue here is that the vagueness and lack of guidance severely
penalizes small players. Larger players both have the experience and
connections to navigate the rules, and also have the financial resources to
absorb the losses when they gamble and lose."

I think the latter part of your larger players argument is most valid: it's
not so much that the big guys have people in FDA who can give them informal
reads, though that's true. It's that the big guys can take the hit of another
year of delay when something doesn't go their way.

------
lkrubner
This sounds like it will be an absolute disaster:

"This act would also create a new, faster approval process for “breakthrough
technologies” that are believed — but not necessarily proved — to offer
significant advantages over existing alternatives. This would allow a device
to be approved based on even lower standards of evidence than are currently
used, on the theory that the need outweighs the risk. The legislation defines
“breakthrough” loosely, creating a perverse incentive for manufacturers to use
this term both to take advantage of the faster approval process and as a
marketing gimmick."

~~~
HeyLaughingBoy
Having been in the Medical Device industry for the past 20 years, I read the
article thinking I was going to disagree with you completely. Now I'm not so
sure.

This is farther than I would have expected the FDA to go. I can see releasing
a device without full clinical trials, because those can be extremely
difficult to set up and can create very long delays. Imagine having to find a
large enough number of people with _just_ the right disease state and who
consent to be part of the group, then getting the right control groups,
building relationships with labs and hospitals in the right places, etc.

But shifting reponsibility from the FDA to a third party is something I'm not
sure I'm comfortable with. There's lots of precedence: nobody ships their
devices off to the FCC for emissions testing, there are independent labs that
sign off on that. Likewise companies such as UL that set safety requirements,
have been around for decades. But as much as we bitch about the hoops we have
to jump through to keep the FDA happy, I think deep down we're all glad they
are there to do the job and keep us honest.

The moderating influence is that device manufacturers as a group are generally
extremely, repeat _extremely_ , conservative. The Quality Assurance engineers
are generally a brick wall that have to be completely appeased before they
will allow anything to be released.

~~~
seehafer
"But shifting reponsibility from the FDA to a third party is something I'm not
sure I'm comfortable with."

This is exactly what happens in Europe, though. And it's one of the reasons we
generally release products there first.

------
bwilliams18
It seems to me like the biggest problem is implantable devices vs external
devices. Anything that would require surgery to recall should have much more
strenuous testing than something you could simply remove and replace without
seeing a doctor. Especially because so many of these implantable devices end
up in older people where the risks of complications from surgery go up so
much.

~~~
seehafer
But they do, and for the authors of this op-ed to try and insinuate otherwise
is massively dishonest. Most implantable devices are what is known as Class
III: the highest risk that FDA assigns. Accordingly, they go through the most
stringent approval process, and they most definitely require multiple clinical
trials.

------
fnordfnordfnord
This ought to be called "experimental" medical devices for some probationary
period pending large scale studies, and people ought to be able to buy and use
them being informed that there is potentially some additional risk. A similar
thing exists for general aviation aircraft for the same reasons.

------
msoad
I know Apple Watch oxidometer and some health related software were disabled
because FDA was not able to approve them fast enough

------
transfire
Pure bunk. The oversight of the FDA on medical devices is one of the worst
parts of the medical system. It is drowning in outdated equipment and limited
supplies of over priced new equipment. The FDA exists to protect profits, not
patients.

------
WalterBright
I've proposed that legally consenting adults be allowed to take any treatment
they want, provided that they sign an affidavit stating they understand that
the treatment is not FDA approved.

The flip side is that FDA approval would grant the drug maker immunity from
lawsuits over deleterious consequences of the drug.

Of course, the drug maker would not be allowed to make fraudulent claims in
either case.

------
reasonattlm
The less FDA the better to my eyes. The incentives are broken, and the FDA is
greatly slowing progress at a time when the potential to create new medicine
is greater than ever before. Regulation is reason why we don't have the first
fruits of the biotechnology revolution in the clinic today.

The much-touted ballpark estimate of a billion dollars to produce a modern
pharmaceutical from start to finish is about a decade old now - that figure is
adjusted for today's diminished dollar value, eroded by inflation. You can
replace "pharmaceutical" with any medical technology that is going to require
a fair amount of original research and further tinkering in the laboratory to
obtain the first working prototypes and the result is much the same. This
large round number is the kitchen sink cost across a decade of work, including
failed attempts and the opportunity cost of investment. The lion's share of
the direct expenditures are imposed by regulatory requirements: trials, data,
and more trials.

It has long been my position that almost all of the work carried out in the US
at the behest of the FDA to prove safety is unnecessary. In fact it is
counter-productive, as the immense imposed costs on development shut out a
great deal of the experimentation and small-scale initiatives needed for rapid
progress. Much of what the FDA demands is not demanded by similar regulatory
bodies in other parts of the world, and even their requirements are very
onerous in comparison to the standards in place fifty years past, a time when
medical development seems to me to have worked just fine. It is a question of
balances and choice: it is better to err in favor of faster progress and
informed patient choice, but that is very far from the present state of
affairs.

The result of an excessive and growing regulatory burden is that many
potential medical technologies languish, are rejected outright, or are never
developed at all, and patients suffer as a result. Our future health is
determined by the pace of progress, and a slowdown across the board harms all
of us considerably. Unfortunately that cost is invisible to the public at
large and thus bureaucrats suffer very little as a result of the harms they
cause by blocking progress. Meanwhile even comparatively small harms caused by
an approved treatment that turns out to be overwhelmingly beneficial save for
some negative effects for some people can snowball in the media to cause great
damage to a career in the FDA bureaucracy. So you can see that the incentives
are very much aligned with ever greater demands for proof and ever greater
costs imposed on medical research and development. This is in fact what has
happened over the past few decades, with the present result that in an age of
radical progress and plummeting costs in the laboratory it is nonetheless the
case that medicine is ever more expensive and the introduction of new
applications of medical research has slowed down. This is well known and
widely commented on, but so entrenched that this detrimental trend shows no
signs of slowing.

So, to return to the cost of developing a modern pharmaceutical product:
estimated at a billion dollars (in today's dollars) ten years ago, the same
approach results in an estimated $2.5 to $2.8 billion dollars now.
Interestingly the bulk of that is apparently not due to the increased time
required to run the regulatory gauntlet, but rather largely due to other
increases in the demands of regulators: much larger trials and more data.

[http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014...](http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study)

[http://lifescivc.com/2014/11/a-billion-here-a-billion-
there-...](http://lifescivc.com/2014/11/a-billion-here-a-billion-there-the-
cost-of-making-a-drug-revisited/)

There is great frustration with this state of affairs, and it manifests with
the creation of organizations such as Faster Cures and Tomorrow's Cures Today,
none of which seem to be making much difference, sadly. The lobbying makes
some people richer, and nothing changes as a result. In the end the only thing
that is going to work is regulatory arbitrage - that the development goes to
other parts of the world, and therapies are available there until the FDA is
shamed into approving them because the people in charge look like clowns if
they don't. This is exactly what happened for stem cell therapies; those
available in the US today would still be held up in interminable trials and
requests for more data without the fact that they have been widely available
in overseas clinics for years. The pattern of activity in the FDA has nothing
to do with safety and efficacy and everything to do with job security for
bureaucrats.

~~~
Fomite
You could also summarize "trials, data, and more trials" not as regulatory
requirements, but actually making sure your treatment works before we put it
into human beings.

~~~
ubernostrum
Also, the origin of the FDA was a time when people could advertise and sell
"medicines" which failed to treat or cure anything, and routinely lie about
the ingredients and their medicinal properties (or lack thereof), a problem
which the free market was conspicuously failing to solve.

So now, anyone can sell medicine, but if they want to claim it's effective for
some disease or condition they have to actually back up the claim.

~~~
seehafer
One could argue that much of government regulation came about because of
massive information asymmetry. In the age of the Internet it is much harder to
peddle snake oil cures (though not impossible, certainly, look at anti-
vaxxers) than it was in the early 20th century.

~~~
Fomite
"Much harder" turns out to still be trivially easy - supplements, the anti-
vaxx folks, every weight loss pill ever...

------
seehafer
I'm willing to accept to a large amount of honest disagreement of how much
regulation is appropriate for medical technology. But articles like this,
which twist the truth and drop so much context make my blood boil.

Some examples:

"Many high-risk medical devices today are approved on the basis of just one
clinical trial (as opposed to new medications, which usually require two
trials)"

This is _only_ true if the medical device in question is an update to an
existing medical device that has extensive clinical data and use in the field.
Sometimes that minor update is as minor as a software modification.

"And only a small minority of clinical studies of medical devices are
randomized, controlled and blinded — the gold standard for reliable evidence"

This is true because it's unethical to conduct major surgery on someone to
give them a placebo, so we can't really blind the studies. They are definitely
randomized and controlled though.

"In fact, according to a 2014 journal article co-written by one of us, the
F.D.A. has never issued a warning letter or penalty for a postmarket study
delay."

This is laughably untrue. I've in fact worked for two companies that received
penalties for not being timely in postmarket surveillance. It might be true
that FDA has never given a warning letter (which is their version of 'you've
been a bad boy, no new products for you until you get your shit together)
solely for postmarket reporting failures, but that's a much different claim.

"When a high-quality clinical trial was finally completed, in 2011, it found
that patients who had the device implanted were more likely to have another
stroke and to die than those just receiving medical management. Despite this
evidence, the F.D.A. did not withdraw the device (though it did narrow its
recommended uses)."

Wingspan was left on the market because for certain classes of patients it was
a good treatment. FDA's action was appropriate.

"But alarmingly, the 21st Century Cures Act would establish a third-party
program of nongovernment authorities to assess whether a company is permitted
to make such changes. The act would enable the device manufacturer itself to
select — and pay — the third party from an approved list. This flagrant
conflict of interest would make it impossible for physicians or patients to
have trust in the safety or effectiveness of updated medical devices."

This is the mechanism that Europe uses to approve all medical devices, not
just changes, and it is not the nightmare scenario the authors make it out to
be. The reason is that the regulatory middlemen have balanced incentives: they
can't be too lax because when they get audited by the European Commission they
can lose their license (and in effect go out of business). They can't be too
strict because a manufacturer has 5 other companies they can do business with.

