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Critics Assail FDA Medical Device Approval Process

July 2011...P&T Journal
    Slow Review Time and Safety Are at Issue


Stephen Barlas

Mr. Barlas is a freelance
writer based in Washington,
D.C., who covers
issues inside the Beltway.
Send ideas for topics
and your comments
to sbarlas@verizon. net.

The FDA is attempting to respond to
complaints about its procedures for
approving medical devices. Those
complaints come at the agency from different
angles.Medical device companies
say that if the FDA doesn’t speed up the
process, foreign competitors will win the
innovation race and hospitals in the U.S.
will see patients go overseas for cutting edge
treatments that domestic hospitals
can’t offer. The Government Accountability
Office (GAO), on the other hand,
has issued repeated reports criticizing
the FDA’s approval process for various
shortcomings that, hypothetically, could
endanger patients who might receive a
faulty implantable device, for example.
Stephen Ferguson, Chairman of the
Board of Cook Group, Inc., a holding
company for manufacturers of many diagnostic
and interventional devices, says:
“There is a real concern that without
improvement in the current regulatory
system, the role of the United States as
the leader in medical innovation will continue
to decline and [will] result in the
migration of patients seekingmedical intervention
abroad where innovation is
thriving and available.”
Diana Zuckerman, PhD, President of
the National Research Center for Women
& Families in Washington, D.C., takes
the opposing view. She says there are far
too many recalls of medical devices. Between
2005 and 2009, there were 3,510
voluntary recalls, an average of just over
700 per year. The majority—nearly 83%—
were classified by the FDA as Class II recalls.
A Class II recall means that the use
of, or exposure to, these devices could
cause temporary or medically reversible adverse health consequences or that the
probability of serious adverse health consequences
is remote. Class I recalls are
the most serious type, constituting only
4% of the total.
Dr. Zuckerman explains: “The bottom
line is that even ‘moderate-risk’ recalled
devices can sometimes result in death
during surgery and certainly add billions
to Medicare costs when they result
in additional surgery and hospitalizations
from the complications of defective
Because of perceived problems with
the approval process, the GAO put the
FDA’s review program on the federal
government’s “high risk” list in 2009,
where it has stayed, as the GAO has
issued successive critical reports,mostly
about the extent of recalls. The FDA
responded by forming some internal
review groups that made recommendations.
In 2011, the agency announced that
it was implementing these recommendations.
To respond to complaints from industry
about the plodding pace of new device
review, the FDA is promoting an “innovation
pathway.” The agency held a
public meeting on that topic in March. Its
initial plan was to pick a couple of medical
devices each year for expedited review;
however, AdvaMed, the medical
device trade group, argues that the FDA
already has such a pathway—its Product
Development Protocol review.
Janet Trunzo, Executive Vice President
of Technical and Regulatory Affairs
at AvaMed, says:
The proposed Innovation Initiative contains
many good ideas, such as early and consistent
interaction and the focus on cooperative
effort, which ultimately should
be applied across the board to all devices to
get safe and effective products developed
and reviewed quickly. The FDA has a number
of tools to achieve these objectives
already available, and it should use them
more broadly and effectively. Minnie Baylor-Henry, worldwide Vice
President of Regulatory Affairs for Johnson
& Johnson Medical Devices and
Diagnostics, notes that the agency has
designated a brain-controlled robotic
prosthetic arm as the first device to enter
this innovation pathway. She agrees it is
a radically different and revolutionary
medical device and ought to be accorded
an expedited review. She adds, however:
“Significantly redesigning a marketed
device to allow it to be used safely and
effectively at home can be an innovative
She also says that the FDA should not
focus exclusively on “technologically
radical” developments.
The approval of new medical devices is
not the only pressing issue facing the
FDA—so is the classification of old devices.
Since 1976, the FDA has been
slowly classifying the 140 categories of
devices that were on the market before
that year, when Congress passed the
Medical Device Amendments of 1976.
That legislation, which amended the
federal Food,Drug, and Cosmetic Act of
1938, required the FDA to categorize all
medical devices as Class I, II, or III, with
III representing the most potentially
dangerous class, including, for example,
implantable devices. Manufacturers of
new Class III devices can submit a Premarket
Approval (PMA) application for
an innovative device, in which case a
clinical trial or similar study is required.
Alternatively, a premarket notification
states that the new device is similar to
one that is already on the market. In this
situation, detailed scientific information
about safety and efficacy is not required—
nor is it typically required for
“new” Class I or II devices.
The 140 categories of devices are referred
to as “pre-amendment” devices.
Only 26 categories remain to be classified,
but they include some widely used
devices that, if identified as Class III,
would have to be the subject of first-time
clinical trials. Examples include auto-mated external defibrillators, implantable
hip joints, and electroconvulsive therapy
devices that are used to treat depression.
Manufacturers of these medical devices
have hinted that they cannot afford clinical
trials and would stop manufacturing
the product if the FDA considered the
devices to be Class III. However, patient
advocacy groups counter that some of
these devices are dangerous and should
be banned or should at least be subject to
restrictions imposed on hospitals where
they are used.