(Repeats story filed Feb. 24 with no changes)
* European official complains to U.S. FDA in letter
* 'Guinea pigs' remark prompts objection
* Europe says appropriate checks required
* Both sides trying to improve oversight, FDA says
(Adds FDA comments paragraphs 11-12, adds details on industry
view in paragraph 8)
By Lisa Richwine
WASHINGTON, Feb 24 A trans-Atlantic spat has
erupted after a top U.S. official suggested European patients
may be "guinea pigs" for medical devices with less government
A senior official at the European Commission, in a letter
obtained by Reuters, complained to the U.S. Food and Drug
Administration this month about comments from the FDA's device
chief, Dr. Jeffrey Shuren.
In defending U.S. device standards, Shuren has highlighted
a few products that were approved in Europe but not in the
United States and later pulled from the market for safety
Speaking to reporters on a conference call in January, he
quoted a plastic surgeon as saying "Under the EU system, the
public are being used as guinea pigs."
"We don't use our people as guinea pigs in the U.S.,"
Paola Testori Coggi, head of the European Commission's
health and consumers department, objected to Shuren's remarks
in a letter to FDA Commissioner Margaret Hamburg.
"I am deeply concerned that a senior official of the FDA
should publicly discredit the regulatory system in Europe in
this way," Coggi wrote in the Feb. 18 letter.
The FDA has been criticized by device makers who say
regulatory requirements are too inconsistent and unpredictable
and discourage development of new technologies.
Both the U.S. and European regulatory systems, "though on
different paths, seek to secure a high level of patient
safety," Coggi said. If the FDA has evidence of unsafe devices
on sale in Europe, "I would appreciate if you could share this
information with European regulators," she added.
EC spokesman Frederic Vincent said the letter was sent to
"clarify the issue and pass on a clear message."
FDA spokeswoman Karen Riley said the FDA and European
regulators "continue to have a very collaborative relationship"
that has "benefited both of us quite well for many years."
"All systems should continually be trying to improve" and
"that is why both we and our European colleagues are actively
looking at ways to help make our systems even better protectors
of public health and promoters of new health care innovation,"
Medical devices range from simple bandages and tongue
depressors to implants such as pacemakers and artificial hips.
Makers include Medtronic Inc (MDT.N) , Johnson & Johnson
(JNJ.N) and Boston Scientific (BSX.N).
Manufacturers have been arguing the FDA's device oversight
is unpredictable and slower than Europe's. At the same time,
consumer groups say the FDA does not require enough testing for
some risky devices.
The FDA proposed changes to device reviews in January but
deferred the most contentious issues. Consumer groups charged
the agency with backing down from tougher oversight in response
to industry complaints. [ID:nN18148261]
President Barack Obama highlighted the changes as an
example of efforts to curtail rules that slow economic growth.
In testimony to the U.S. Congress last week, Shuren said
Europe's system did not require government review before a
company could market a device or proof of effectiveness.
Coggi's letter said Europe requires "appropriate checks" to
show the device is safe and that "any remaining risks are
acceptable when weighed against the benefits."
"On both sides of the Atlantic, we are currently assessing
how our respective regulatory systems can be further improved.
But this is not a reason to pit one system against the other,"
(Reporting by Lisa Richwine in Washington and John O'Donnell
in Brussels; editing by Carol Bishopric)