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>> New findings from a
congressional investigation into
the fda and the biotech company
bio Jen found the fda broke its
own protocols to approve a new
Alzheimer's drug last year.
The findings conclude the
regulator worked too closely
with them, despite the benefits
and side effects of the new
drug.
Geoff Bennett has that.
>> When the fda approved the
drug in June of 2021, bio Jen
hoped to earn billions of
dollars within a few years.
A congressional report found
numerous problems in the lead up
to that approval, including the
fda's interactions with biogen
work atypical and included
collaboration in at least 150
meetings, calls, and emails.
The fda approved them for
Alzheimer's patients despite the
lack of lineker trial data and
concerns of fda advisors.
And they said and unjustifiably
high price of $56,000 a year for
patients in order to "Make
history."
They have worked on their own
investigation into all of this.
Reporter Damien carb day joins
us.
This report is the result of an
18 month investigation by two
house committees.
Investigators reviewing some
500,000 documents from the fda.
Investigators concluded the fda
went way beyond its normal
protocol in bringing the drug to
market.
Tell us more about that.
>> As they concluded, the
process was rife with
irregularity.
What it boils down to is in the
normal process by which drugs
are approved, the fda is a
neutral regulator, an
oppositional relationship they
might have with the drug company
seeking approval.
It went to the data very
seriously and very earnestly.
A person or doctor prescribing a
drug can be certain benefits and
risks have been thoroughly
examined by an independent body.
In this case, what we had
reported previously is the fda
worked more like a collaborator.
Worked hand in glove with biogen
preparing the materials for
those independent advisors and
working behind the scenes to
find a way to approve the
medicine over the concerns on
the community had voiced at that
point.
>> Let's talk about the price.
They have an annual price tag of
$56,000, which executives
previously called fair and
responsible.
How did they arrive at that
price?
>> That is fascinating.
We heard so much backlash to
drug pricing and the rising
costs of new medicines, and
every conceivable defense from
drug companies.
Things to the investigation, we
got a look at how the company
actually came up with it.
What we learned is they surveyed
insurance companies and
neurologists to test a range of
prices to see how people felt
about them.
They concluded charging about
$20,000 or $15,000 a year would
be a way to maximize the most
number of patients who could
have access to the drug.
Anything over $40,000 a year was
going to run into pushback and
backlash.
They chose $56,000 a year in the
name of what they described as
revenue maximization.
The goal to make history with
what would have been by their
calculations the largest
pharmaceutical product in
history.
>> The report also delves into
the initial decision to approve
them for Alzheimer's patients
across the board, even though it
was really indicated for people
with mild early stages of the
disease.
Tell us more about that.
>> That is especially
fascinating.
Even biogen was shocked they
were considering and decided to
approve it for all 6 billion
Americans with Alzheimer's
disease rather than the subset
in who the drug had been
studied.
They did not pushback against
it, which the congressional
committees kind of knocked them
for.
The mystery remains why did the
fda do this?
You have seen internal
documents, their justification
for it.
It is unclear why the agency,
knowing how controversial it was
at the time, chose to approve it
for such a large number of
people.
>> In response, they refuted the
implications, saying it stands
by the integrity of the actions
we have taken.
The fda previously determined in
its own review officials acted
appropriately and started
implementing the reports
recommendations.
The fda is now evaluating two
other Alzheimer's drugs for
possible approval early next
year.
What are the implications of
this report on that process?
Fascinating timing.
Any day now, probably next week,
we will learn another
Alzheimer's treatment, a
different one with less baggage
attached, will likely win fda
approval.
That process is technically
separate from the one they had.
But the timing is uncomfortable
for the fda.
The world has seen them rebuke
the process.
The process of rebuilding the
reputation really begins to
neurologist, patients, everyone
in this community.
The fda approval means it is
well understood and the label
reflects the evidence behind the
given treatment.
There is no guarantee the next
approvals will be received as it
would have been.
>> Thank you so much for your
time and insights.