Page 8 - Public Citizen News November-December 2013

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8
November/December 2013
Public Citizen News
By Sarah Sorscher
In fall 2012, more than 700 pa-
tients were sickened by a con-
taminated injectable steroid dis-
tributed earlier in the year by the
New England Compounding Cen-
ter (NECC), a company located in
Framingham, Mass.
More than 60 people have died
since the outbreak began, and
other infected patients have ex-
perienced meningitis, infection
around the spine, stroke or in-
flamed joints. Thousands remain
at risk from slow-moving infec-
tions and may not develop symp-
toms for months or even years,
according to Centers for Disease
Control and Prevention officials.
One of the hundreds infected
was Angel Farthing, a former fit-
ness instructor from Abingdon,
Md. She experienced a stroke, an-
eurysm and spinal abscess, and
suffers debilitating pain that lim-
its her from exercising or danc-
ing, once her favorite hobby. She
shared her story with the public
on the website of the Working
Group on Pharmaceutical Safe-
ty, which has been coordinating
with Public Citizen to strengthen
the laws governing pharmacy
compounding.
“I’m truly thankful to be alive,”
Farthing said on the website,
adding that she wants to see a
change that will protect patients
Compounding Pharmacies
Or Big Drugmakers?
from contaminated shots and
drugs.
Public Citizen has been keeping
tabs on the fallout from the NECC
disaster. After the news of the
outbreak, Public Citizen pressed
the Food and Drug Administra-
tion (FDA) to re-inspect com-
pounding pharmacies that had
caused problems in the past and
take more aggressive enforce-
ment action when it detects ille-
gal drug manufacturing. The FDA
responded by dramatically in-
creasing its inspection efforts and
posting its negative inspection
findings online. (You can view
these reports by visiting www.
fda.gov and typing “Pharmacy
Compounding FDA Actions” in
the search box).
Mass-produced drugs
under the guise of
pharmacy compounding
The drugs that harmed Far-
thing and hundreds of other pa-
tients had not been approved by
the FDA or reviewed for safety
and effectiveness. While it is ille-
gal for companies like the NECC
to mass-produce drugs with-
out FDA approval, an increasing
number of companies calling
themselves “compounding phar-
macies” have been able to evade
federal oversight and engage in
this type of unapproved drug
manufacturing without facing
any legal consequences.
They do this by claiming that
what they are doing is not drug
manufacturing at all, but is in
fact traditional pharmacy com-
pounding, which some courts
have said is not subject to certain
types of FDA oversight, includ-
ing authority to inspect records
and require new drug approval
applications. Traditional phar-
macy compounding is small-
scale and involves producing in-
dividually tailored medication to
meet needs that cannot be met
by standardized, FDA-approved
products.
Over the past two decades,
more and more traditional com-
pounding pharmacies have real-
ized that they can make more
money if they scale up produc-
tion and make large batches
through
more
standardized
processes.
Some have even developed
brand names for their products
and have hired marketing de-
partments to maneuver their
wares onto the shelves of doc-
tors’ offices and hospitals. These
practices exceed the scope of
traditional compounding and
are essentially drug manufac-
turing activities in disguise. No
court has disputed the FDA’s au-
thority to prosecute pharmacies
that are engaged in illegal drug
manufacturing.
While the FDA increased the
number of inspections of these
pharmacies after the outbreak
last year, the agency still falls far
short when it comes to enforce-
ment. In July 2013, the FDA failed
to follow up after requesting that
the NuVision Pharmacy in Dallas,
Texas, recall its products, which
the agency had learned were as-
sociated with reports of fever,
flu-like symptoms and soreness
(possible signs of infection). The
FDA stated that NuVision’s ster-
ile products were adulterated,
and that failing to initiate a recall
would result in “further regula-
tory action.”
NuVision declined to comply
with the FDA’s request and order
a recall, and the FDA subsequent-
ly backed down, issuing a public
health alert instead of seeking to
impose criminal or civil penalties
against NuVision.
One of the reasons that the
FDA may be reluctant to act more
aggressively is out of concern
that recalling drugs or closing fa-
cilities to address quality issues
could lead to drug shortages.
Many hospitals and doctors’ of-
fices have come to rely on com-
pounding pharmacies for a ready
supply of relatively unregulat-
ed products. Too often, health
An increasing number of so-called “compounding pharmacies” are evading federal
oversight and mass-producing drugs. Public Citizen is working to stop this illegal practice.
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