
FDA Approving Drugs at Breakneck Speed, Raising Alarm - eplanit
https://www.msn.com/en-us/news/money/fda-is-green-lighting-drugs-at-breakneck-speed-and-raising-alarm/ar-BBXRMmR
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1123581321
This is a good thing. People die, and die sooner, when the FDA cannot adapt
its approval process to drugs and tools for patients who sadly have little
downside to trying them.

In my own little corner (diabetes) it’s been nice to get monitoring tools
earlier than they once would have been approved, and for my medical team to
confidently plan for equipment changes based on future approvals.

~~~
Retric
Only a fraction of drugs treat life threatening condition in some new way.
Painkillers for example represent a surprising fraction of all drugs and
generally have a close equivalent.
[https://www.drugs.com/condition/pain.html](https://www.drugs.com/condition/pain.html)

Taking enough time to endure a new acne medication or Viagra alternative etc
is reasonably safe is very much worth spending some extra time.

Edit: This does seem to be focused on needed medications without close
equivalents but that’s a fairly arbitrary line.

~~~
tpmoney
Close equivalent can still be something you can't take. For example, if you're
one of the unfortunate people with no activity on your CYP2D6 enzyme, there
are essentially 4 pain medications that you can take at appropriate doses once
you need something stronger than advil: Morphine, Dilaudid, Oxymorphone and
Fentanyl, and there are reasons why doctors prefer other narcotics before
prescribing any of those 4. Other pain medications will work, but you'll
likely need inappropriately higher doses[0], which can lead to other problems
(like overdosing). Likewise if you process faster than a normal person (i.e.
you have more activity on that enzyme) you can overdose at normal prescribing
doses. Close equivalents for some people can indeed be the difference between
life and death, even if the condition itself isn't life threatening.

[0]:
[https://www.ncbi.nlm.nih.gov/books/NBK100662/](https://www.ncbi.nlm.nih.gov/books/NBK100662/)

~~~
Retric
That’s a very good point, but then we are talking about edge cases and a delay
measured in weeks to months. So, the benefit from catching 1 bad drug could
outweigh the benefits from releasing 100 drugs slightly earlier.

It’s not an easy choice, especially when the risks are often hypothetical and
the benefits so clear.

It’s interesting looking at lists like this and considering where things
broken down.
[https://en.m.wikipedia.org/wiki/List_of_withdrawn_drugs](https://en.m.wikipedia.org/wiki/List_of_withdrawn_drugs)

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ekianjo
> “It isn’t that we changed our policies and are saying we are going to
> approve drugs faster,” said Janet Woodcock, director of the FDA’s Center for
> Drug Evaluation and Research, who joined the agency under President Ronald
> Reagan. “The difference now is we are going to see more of those because of
> the science. If there are people out there with no options and they have
> terrible diseases, we are going to get those drugs to them as fast as
> feasible.”

> But even as drugmakers, investors and patients cheer on the agency’s pace,
> patient-safety advocates argue that speed comes at a price. Studies show
> medicines approved on a faster time line are more likely to have safety
> problems emerge after they become broadly available, while other treatments
> offer fewer benefits than anticipated.

Not sure I understand the concern:

\- "studies show medicines approved on a faster time line ...": which
study(ies)? And that was the case for previous track records, which says
nothing if the FDA is making the same mistakes that they may have done 20
years ago.

\- "more likely to have more safety concerns once they are broadly available
while other treatments offer fewer benefits than anticipated", wait, do such
studies actually have drugs that are virtually identical in all properties and
where the only factor that changed is the approval timing? Because if that's
not the case, you are just comparing drugs with different profiles, different
indications, and different targets, which is pretty much apples and oranges.
Good luck making conclusions based on that.

I am not aware of the FDA or any other regulatory body at this time starting
to remove regulatory requirements to speed up approvals. The typical things we
see nowadays is an exception for "orphan indications" where there is no good
treatment available and people are dying without anything to try. It seems
fair that they take in account patients' needs when it comes to expediting the
last bureaucratic mile to ensure new drugs can save more patients. At the end
of the day, patients are also free to refuse newer drugs (and doctors usually
tell them when a drug has just been approved and when there is lack of much
safety experience beyond clinical trials) so I don't see how you can frame
this whole story in a negative light.

~~~
caseysoftware
I think this is the key section:

_"It’s not just speed. The FDA also is approving more drugs, hitting a record
59 new therapies in 2018. Almost three-fourths received a priority review.
That, combined with more efficient data collection, is responsible for the
faster FDA action, said Aaron Kesselheim, a professor at Harvard Medical
School. Companies are also communicating earlier and more often with the
agency, which can head off issues at preliminary stages and help them get
products through on the first attempt, he said."_

So as in _any_ field, better communication with stakeholders improved the
process and eliminated some issues earlier.

Then, better data collection helps them evaluate studies better. I bet it also
reduces the back and forth and the "what does this mean" aspect of the studies
after.

And then companies can pay for expedited evaluation.. which if they've been
communicating clearly all along and have better data, doesn't seem far
fetched.

The next thing you know, someone will suggest clear planning with
stakeholders, code reviews, and unit tests will improve code quality and even
ship dates! But that may be crazy talk.

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mrfusion
How about we raise an alarm when drugs aren’t approved promptly? People die
when good drugs are held up in bureaucracy.

~~~
domnomnom
Woah that's quite a claim. Care to expand?

~~~
showyrfangs
There are plenty of example of drugs costing 10-100x what they normally would,
which pharma companies get all the heat for, are drugs that would otherwise
have plenty of competition but dont due to to backlogs at the FDA.

Including the most famous one: Epipens

[https://slatestarcodex.com/2016/08/29/reverse-
voxsplaining-d...](https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-
drugs-vs-chairs/)

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qrbLPHiKpiux
Doc here.

I was at a continuing education course last year. FDA approved a new narcotic
very fast. A non narcotic alternative is taking forever to approve.

Its name is Maxigesic. Tylenol and ibuprofen in one pill.

Why?

~~~
refurb
As someone who works in the drug industry, when Maxigesic is approved, please
don't prescribe it. Just tell your patients to take one each of the OTC drugs,
they are dirt cheap (like $0.02 per pill).

The market is full of drugs that are combinations of OTC medications and
usually they are way more expensive. Even if they didn't go nuts with the
price, why make a patient pay $0.50 per pill when they could take 2 for $0.04?

~~~
ensignavenger
Some patients have a lot of pills to take, and they would rather pay more to
take fewer. Maybe they have trouble keeping track of them, maybe it is just
pill fatigue. Maybe they have trouble swallowing for one reason or another.
Combo pills could be a good thing for a subset of the population. Sure, it
requires doctors to be on top of their game and patients to research what they
are taking and ask questions, but that doesn't mean it isn't a good idea to
have it available as an alternative.

As to the question about why it is taking so long at the FDA, I imagine it
isn't a very high priority because there are alternatives.

~~~
refurb
I don’t disagree that pill burden can be an issue.

The problem is the lack of transparency into cost which results in some drug
companies taking advantage.

Combine two pills that cost $0.10 each into one pill that costs $0.15?
Reasonable.

Do the same and charge $5 per pill? Ridiculous. Problem is doctors and
patients don’t know it costs $5 and insurers can’t be bothered to push back.
Suddenly you’ve increased the cost of therapy by 50x.

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bitxbit
FDA is grossly understaffed. And more importantly, its policies are directly
responsible for the skyrocketing prescription drug prices.

~~~
dannyw
Could you give some examples? As far as I know, the policies of Congress are
what is responsible for skyrocketing prescription drug prices.

~~~
spsful
Same thinking here. I don't believe the FDA is forcing drug prices onto the
public; it seems to be a system enabled by congress and abused by the public
sector.

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rhexs
What party has some sort of vested interested (presumably monetary) in slowing
down FDA drug approval? Perhaps I'm being a bit pessimistic here, but after
reading the article I don't really see any motivation for the "raising alarm"
statement in the title, or even a reason anyone would bother publishing this
in the first place.

I looked up the "consumer watchdog" that I'm guessing had something to do with
this article, and their front page is just an "Impeach Trump" advertisement.
See [https://www.citizen.org/](https://www.citizen.org/). Also, if you click
their "About Us" page, a few lines down is: "We don’t participate in partisan
political activities or endorse any candidates for elected office."

Hmm.

~~~
burpsnard
We've been hearing for years about accelerated drug candidate discovery
through better tech and automation, and anecdotally a boom in clinical trials
informatics etc, so not surprising

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gesman
Enough gazillion dollars can compress time and expand space.

