Big
pharmaceutical
companies
are
boosting
their
production
capacity
of
branded
pharmaceutical
products
with
billions
of
dollars
in
new
U.S.
manufacturing
plant
construction,
but
generic
drug
production
still
remains
mostly
overseas.
The
FDA
is
addressing
this
imbalance
through
a
new
pilot
program
that
incentivizes
domestic
manufacturing
of
generic
drugs
by
speeding
up
the
regulatory
review
of
these
medicines.
Under
the
new
pilot
program
announced
Friday,
eligible
drugmakers
must
source
the
ingredients
and
make
the
finished
drug
product
within
U.S.
borders.
These
requirements
are
consistent
with
other
initiatives
the
Trump
administration
has
introduced
as
part
of
a
broader
strategy
to
reshore
pharmaceutical
manufacturing.
More
than
half
of
pharmaceuticals
distributed
in
the
U.S.
are
manufactured
overseas,
the
FDA
said.
Even
when
drugs
are
made
in
the
U.S.,
the
finished
product
often
uses
an
active
pharmaceutical
ingredient
(API)
from
overseas.
By
the
agency’s
count,
just
9%
of
API
manufacturers
are
in
the
U.S.
while
22%
are
in
China
and
44%
are
in
India.
The
FDA
reviews
generic
drugs
under
the
abbreviated
new
drug
application
(ANDA)
pathway.
Typically,
a
drug
going
through
this
pathway
must
undergo
clinical
testing
to
show
bioequivalence
to
the
reference
product,
the
already
FDA-approved
drug.
Much
of
the
clinical
testing
of
generic
drug
candidates
is
conducted
outside
of
the
U.S.,
which
the
FDA
contends
weaken
the
U.S.
pharmaceutical
and
R&D
infrastructure.
To
qualify
for
the
new
pilot
program,
a
drugmaker
must
conduct
any
required
bioequivalence
testing
in
the
U.S.
Also,
the
product
must
be
made
in
the
U.S.
using
exclusively
domestic
API
sources.
Documentation
showing
a
drug
meets
these
requirements
must
be
included
in
a
company’s
request
seeking
this
new
type
of
priority
FDA
review.
“Overreliance
on
foreign
drug
manufacturing
and
testing
creates
risks
both
to
national
security
and
patient
access,
and
undermines
investments
in
U.S.
research,
manufacturing
and
production,”
said
George
Tidmarsh,
director
of
the
FDA’s
Center
for
Drug
Evaluation
and
Research,
said
in
the
agency’s
Friday
announcement.
“It
also
slows
down
reviews
and
costs
taxpayers
more
money,
as
these
foreign
research
and
testing
sites
must
be
inspected
by
FDA,
and
foreign
inspections
take
more
time
to
prepare
for
and
are
more
expensive
to
conduct
than
domestic
inspections.”
The
agency
did
not
quantify
how
much
faster
generic
drugs
will
be
reviewed
under
the
new
pilot
program.
But
domestic
production
is
a
key
component
of
another
FDA
pilot
program
focused
on
branded
products.
This
program
unveiled
in
June
makes
certain
branded
drugs
eligible
for
a
shorter
regulatory
review
as
long
as
the
qualifying
product
meets
certain
national
health
interests,
such
as
addressing
a
national
security
health
crisis
or
increasing
domestic
production
as
a
matter
of
national
security.
Drugs
that
qualify
for
this
program
would
be
awarded
a
Commissioner’s
National
Priority
Review
Voucher
that
shortens
regulatory
review
to
two
months.
Big
pharma
companies
have
been
boosting
U.S.
manufacturing
capacity
as
a
way
to
avoid
potential
pharmaceutical
tariffs
that
the
president
has
threatened
to
impose
on
imported
drug
products.
In
late
September,
Trump
said
in
a
social
media
post
that
tariffs
would
be
imposed
on
branded
drugs
unless
the
product’s
manufacturer
is
breaking
ground
or
constructing
a
pharmaceutical
plant
in
the
U.S.
The
post
did
not
refer
to
generic
drugs,
suggesting
these
products
will
be
exempt
from
tariffs.
Trump
has
taken
other
steps
to
strengthen
domestic
drug
production.
A
May
executive
order
directs
the
FDA
to
evaluate
existing
regulations
with
a
goal
of
streamlining
the
review
and
permitting
of
new
domestic
drug
manufacturing
facilities.
In
August,
the
FDA
introduced
PreCheck,
a
program
that
provides
pharmaceutical
manufacturers
with
more
frequent
communication
during
the
development
stages
of
new
facilities
and
streamlines
the
chemistry,
manufacturing,
and
controls
section
of
the
application
to
build
a
new
facility
with
pre-application
meetings
and
early
feedback.
Last
week,
the
FDA
held
a
public
meeting
to
discuss
the
new
PreCheck
program.
Domestic
API
production
is
a
key
component
of
yet
another
executive
order.
This
August
order
directs
the
Department
of
Health
and
Human
Services
to
compile
a
list
of
critical
medicines.
The
government
will
then
stockpile
APIs
for
these
drugs,
which
the
order
states
will
insulate
the
U.S.
from
the
foreign
concentration
of
this
piece
of
the
supply
chain
while
also
encouraging
more
domestic
production
of
APIs.
Photo:
Stuart
Ritchie,
Getty
Images