FDA rips Europe's system for medical
device reviews Article by: JIM SPENCER and JAMES WALSH , Star Tribune
Updated: April 22, 2012 - 9:33 AM
Agency disagrees with device makers who see Europe as a model
for product approvals.
WASHINGTON - CorCap was a mesh bag
that fit over the bottom of the human heart to treat congestive heart failure.
Nobody questioned whether surgeons could safely install it. It sold in Europe
for years.
But CorCap never got on the U.S.
market for one reason: Its maker, Acorn Cardiovascular of New Brighton, could
not convince the U.S. Food and Drug Administration (FDA) that CorCap worked
better than drug therapy.
Today, Acorn Cardiovascular is out of
business, despite $100 million in development capital. CorCap is no more.
In a new internal report obtained by
the Star Tribune, the FDA claims the device's demise as a victory for American
patients and an affirmation of the U.S. medical device approval process.
The strongly worded document details
what the FDA says are 12 classes of malfunctioning or needlessly invasive
high-risk medical devices approved for sale in Europe but not the United
States. It represents an FDA defense of its practices while industry groups,
patient advocates and some in Congress propose changes in the way the agency
does business.
"If a device gets on the market
somewhere else first [and] it's a good device, good for them; if it's a bad
device, bad for them," said Dr. Willam Maisel, FDA's deputy director for
science. "The only way to know that is to look at some of the devices and
see how they played out."
The report, "Unsafe and
ineffective devices approved in the E.U. that were not approved in the
U.S.," indicts a European system that American medical device makers,
including hundreds of Minnesota companies, have held up as a model for getting
lifesaving devices to market faster. It comes as Congress debates
reauthorization of the Medical Device User Fee Act, the law under which devices
are reviewed.
"We were anticipating questions
about the type of data we ask for," Maisel said in explaining why the
agency gathered the information. "This is the evidence."
Device recall expert Diana Zuckerman
of the National Research Center for Women & Families said the report looks
like FDA pushback against industry lobbying. "One of the big issues for
lobbying is the device industry telling Congress that the system in Europe is
so much better than the system in the U.S.," Zuckerman said.
The United States generally requires
proof that high-risk medical devices benefit patients in "clinically
significant" ways, while the European Union generally does not. The
difference can mean years of expensive clinical trials.
The device industry contends that the
FDA's slower approval of high-risk devices drives U.S. businesses overseas,
costing high-paying jobs and keeping U.S. patients from badly needed relief.
"Nobody knows how to define
clinically significant," said Acorn Cardiovascular founder Steve Anderson,
whose company spent six years trying to prove CorCap's effectiveness. "We
were burning more than $1 million a month just for personnel running the
[clinical] trial."
Shay Mandle, vice president for
government relations at industry group LifeScience Alley, said there are no
data to suggest that people in the E.U. are getting more bad devices than in
the United States.
"The E.U. system is working
better today than the U.S.," said Mandle, whose group represents more than
600 medical technology businesses employing 250,000 people in Minnesota.
"The rationale for most companies going to the E.U. is that it's more
predictable."
University of Minnesota law professor
Ralph Hall, who consults for medical device companies and studies the device
industry, branded the unpublished FDA report "political." It is
intended to deflect criticism from the FDA's performance and to neutralize
legislation the FDA doesn't want, Hall said.
He called the report one-sided,
looking only at E.U. failures. In some cases, the FDA went back more than 15
years to make its point, Hall said.
FDA critics in the House and Senate
hope to add language to new-device legislation that, among other things,
expands humanitarian exemptions for high-risk devices that require no
effectiveness testing. Industry-driven measures also aim to change the FDA's
mission statement to include job creation.
The report makes clear that the FDA
does not want to move toward a more European approval model.
"Lowering standards of approval
for devices in order to speed access can jeopardize patient health and impose
high but often hidden costs," the FDA warns.
In the report, the FDA included a
chart that compared approval standards. The agency says that the E.U. demands
less evidence and allows private, for-profit companies to approve products for
sale throughout the E.U.'s 27 member countries. Approvals and the evidence on
which they are based are not disclosed publicly, the FDA said. Neither are side
effects or recalls, the FDA says.
Others have questioned the European
system. A February article in the New England Journal of Medicine reported that
"a recent recall of a popular breast implant that was approved only in the
European Union has reinforced European concerns about the clinical evaluation
of high-risk devices."
Linda Alexander, who leads Alquest, a
Minneapolis firm that helps device makers navigate the FDA, believes that the
FDA prepared its report to boost staff morale.
Alexander said effectiveness testing
is not as black-and-white as the FDA tries to make it. Annual recalls of risky
medical devices are the same in the United States and the E.U., said Alexander,
who worked 10 years for Minnesota device maker Medtronic.
"Companies are going to Europe
in order to stay in business," she said. Selling devices in Europe often
provides money manufacturers need to pay for clinical testing here.
Congressional efforts
Sen. Amy Klobuchar, D-Minn., and Rep.
Erik Paulsen, R-Minn., have been especially vocal supporters of industry
efforts to get medical devices to market faster.
Paulsen said in an interview that he
favors effectiveness tests before allowing devices on the market.
"You should absolutely test for
efficacy and safety, and I've never suggested otherwise," Paulsen said.
"I've held up the European system as a model, not because it has a
different standard, but because it is consistent, it's transparent, it's
efficient and it's predictable. The U.S. system has become less so."
Klobuchar issued a statement: "I
believe we can still make the approval process more efficient while increasing
predictability, transparency and safety."
At least one Minnesota-made device
awaiting FDA approval falls into a group that comes under severe FDA criticism
in the report.
The agency blasted patent foramen
ovale (PFO) occluders -- surgically implanted devices that close a congenital
heart defect in stroke patients -- as no better than aspirin in preventing
future strokes.
St. Paul-based St. Jude Medical Inc.
sells its Amplatzer PFO occluder in Europe and other major world markets and
hopes to sell it in the United States. The company just completed a major
clinical trial but has not shared results with the FDA, said spokeswoman Amy Jo
Meyer.
But a March 15 article and editorial
in the New England Journal of Medicine reported results of a clinical trial
involving another PFO occluder, the NMT StarFlex. It proved no more effective
than aspirin in preventing a recurrence of strokes, researchers found. Worse,
it caused a greater incidence of potentially harmful irregular heartbeats.
"During the nine years it took
for the results of this trial to be reported," Dr. Claiborne Johnston of
the University of California San Francisco Medical Center wrote in an
editorial, "... $400 million was spent [around the world] on a procedure
that had no apparent benefit, to say nothing of the clinical risks
involved."
In an interview, Johnston said
"the pendulum has swung too far" toward time-consuming FDA approvals,
but that does not eliminate the need to measure product benefits.
"Society," he said, should
not be "reimbursing for worthless devices."
Jim Spencer • 202-408-2752 jim.spencer@startribune.com
James Walsh • 612-673-7428 • jwalsh@startribune.com
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