Page 9 - Public Citizen News November-December 2013

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November/December 2013
Public Citizen News
care providers fail to recognize
the quality differences between
compounded products and FDA-
approved drugs.
The FDA also claims that the
federal laws governing drug
compounding are unclear. In
the past, the FDA has won legal
challenges against compound-
ing pharmacies where it has been
able to show that the pharmacy is
engaged in drug manufacturing,
but gathering this evidence takes
time and resources, and the line
between drug manufacturing
and compounding is not always
“Our health care system is be-
coming dangerously dependent
on unapproved drugs to meet
needs that were once met exclu-
sively with FDA-approved, man-
ufactured products,” said Dr. Mi-
chael Carome, director of Public
Citizen’s Health Research Group.
“The FDA needs to move swiftly
to control this problem, or we are
going to see a repeat of the NECC
A need for better laws
and better enforcement
Following the disaster, Public
Citizen worked with the office
of Rep. Rosa DeLauro (D-Conn.)
to introduce the Supporting Ac-
cess to Formulated and Effec-
tive Compounded Drugs Act (the
SAFE Act, H.R. 6638), a bill that
would clarify the line between
traditional compounding and
drug manufacturing, expand the
FDA’s authority to register and in-
spect pharmacies for drug manu-
facturing activities, prevent the
compounding of unsafe prod-
ucts, and require pharmacies and
doctors to inform patients when
a drug was compounded and not
Unfortunately for patients,
the FDA and other groups sup-
ported a proposal that would
have created a new class of busi-
nesses, called “compounding
These companies would have
to promise to meet the federal
manufacturing standards that
apply to FDA-approved drugs
from pharmaceutical compa-
nies, with two major differences:
would not have to undergo pre-
market approval and inspec-
tions, and they would be exempt
from certain federal labeling re-
quirements. This proposal was
incorporated into a bill approved
by the Senate Health, Education,
Labor, and Pensions Committee
(HELP Committee).
Under current law, it is illegal
for a compounding pharmacy
to manufacture standardized,
mass-produced drugs without
seeking new drug approval. The
FDA’s proposal would legalize
this type of unapproved large-
scale drug manufacturing, ef-
fectively creating a new class of
manufacturers subject to less
federal oversight than other
This new class of manufacturers
would help the FDA fund its en-
forcement efforts by registering
with the agency and paying reg-
istration and inspection fees.
While this would relieve the
FDA of the difficulty of iden-
tifying and shutting down il-
legal manufacturers, it would
be an enormous step backward
for public health, legalizing the
same practices that contributed
to the NECC disaster.
Public Citizen fought hard to
prevent this flawed proposal
from passing Congress, and its
efforts were partially successful.
The FDA’s original plan failed to
gain enough support in Congress.
Another bill, the Drug Quality
and Security Act (H.R. 3204), is
much narrower in scope than the
earlier bill approved by the Sen-
ate HELP Committee.
However, Public Citizen op-
poses this bill — which has been
passed by the U.S. Congress and
is awaiting the president’s sig-
nature, as of press time — be-
cause it allows manufacturing
of unapproved drugs (by enti-
ties labeled “outsourcing facili-
ties” rather than “compounding
manufacturers”). Yet the scope
of activity permitted for these
companies is much more lim-
ited: Under the new bill, out-
sourcers will be able to make
drugs from raw ingredients only
if they appear on the FDA drug
shortages list, a list the FDA has
created for FDA-approved drugs
that are temporarily in short
H.R. 3204 does not require
adequate warning labels to no-
tify patients that a drug is com-
pounded and not FDA-approved.
It also fails to clarify some of the
ambiguities that have led to legal
challenges in the past, meaning
many companies will continue to
engage in illegal drug manufac-
turing under the guise of phar-
macy compounding.
“To prevent another NECC-
like disaster, the FDA will have
to change the way it carries out
enforcement. This means spend-
ing more resources to identify
illegal drug manufacturing and
being more aggressive about
enforcing the law when it dis-
covers problems,” Carome said.
“Once the compounding legisla-
tion is signed by the president,
as expected, Public Citizen plans
to press the FDA even harder to
step up enforcement efforts and
clean up the drug compounding
By Dr. Sidney Wolfe, founder and senior adviser
of Public Citizen’s Health Research Group
Sadly, last year’s outbreak linked to contami-
nated injectable drugs manufactured by the
New England Compounding Center
(NECC) was not the deadliest out-
break of its kind in U.S. history.
I was a researcher at the National
Institutes of Health (NIH) in early
1971 when a colleague called to tell
me that contaminated intravenous
(IV) fluids distributed by Abbott
Laboratories had caused more than
100 cases of a rare bacterial infection,
with nine deaths reported by then.
The Food and Drug Administration
(FDA) knew about the problem but
had decided not to recall the fluids,
fearing that a recall would create a
drug shortage because half the IV flu-
ids in the U.S., made by Abbott, were potentially
Suspecting there might be more to the story,
I called Abbott’s competitors and found that
they had stockpiled ample supply of IV fluid to
meet the country’s needs. I also called my then-
acquaintance, Ralph Nader, who suggested we
write to the FDA demanding an immediate recall
of the Abbott IV fluids. We released the letter to
the press, and within a few days — not long after
the previous decision against a recall — Abbott
recalled the contaminated fluids.
It was already too late for some. According
to the government, after the full scope of this
epidemic of infected IV fluids was determined, an
estimated 2,000 to 8,000 patients had blood-
stream infections and between 200 and 800 peo-
ple had died, a number that surely would have
been much higher had the recall not occurred.
The Abbott IV fluid disaster is now
thought to be the largest and most
lethal known outbreak of hospital-
acquired infection linked to a single
contaminated medical product in
U.S. history. The disaster taught me
the power of research-based activ-
ism, resulted in my leaving the NIH
and started my career as a lifelong
consumer advocate by founding
Public Citizen’s Health Research
Group with Nader in late 1971.
It also, at least temporarily, taught
the FDA a lesson. The agency sub-
sequently developed much tighter
regulations to prevent contamina-
tion of sterile FDA-approved drugs. No similar
outbreak has even come close in size or deadli-
ness to the Abbott IV disaster until the outbreak
linked to contaminated steroids last year, which
– just counting the single outbreak at the NECC
– already has been associated with 751 infections
and 64 deaths.
The FDA seems ready to forget the lessons
from history and is poised to undo a large part
of what Public Citizen and others have fought so
hard to accomplish for drug safety over the past
four decades. Now, more than ever, our advocacy
is needed to protect the public from special inter-
ests who would seek to intimidate government
officials into inaction.
America’s Deadliest Outbreak
From Contaminated Medicine
Dr. Sidney Wolfe