By Anna YukhananovWASHINGTON, Oct 13 (Reuters) - A bill that would loosen
conflict of interest rules for advisers to the Food and Drug
Administration has been proposed by three U.S. senators seeking
to speed up review times for medical devices.The measure would reverse 2007 legislation that barred
experts who had financial ties to a company or its competitor
from serving on an advisory panel without a waiver. There is
also a limit on the number of waivers that keeps decreasing.A senior FDA drugs office official testified in August that
the agency was having difficulty in recruiting highly qualified
people for its advisory panels.The legislation also comes as medical device makers such as
Boston Scientific and Stryker have criticized
the FDA for strangling innovation with inconsistent regulation
and lagging device approvals.”The legislation would restore the appropriate balance to
conflicts of interest requirements by requiring the FDA to be
subject to the same conflicts of interest requirements as the
rest of the federal government,” according to a statement
issued by the senators.Federal regulations allow those with conflicts to serve as
advisers as long as the conflict is publicly disclosed and is
“unavoidable.”“It is critical that we don’t allow regulatory burdens to
get in the way of delivering lifesaving products to the
patients who need them,” said Senator Amy Klobuchar, a Democrat
from Minnesota. “This legislation will help ensure that we have
processes that promote safe, pioneering technologies that help
save lives and create good jobs in Minnesota.”Minnesota, home to devicemaker Medtronic , has about
30,000 jobs in the medical device industry, according to
AdvaMed, an industry trade group.Klobuchar proposed the bill along with Senator Richard
Burr, a Republican from North Carolina, and Michael Bennet, a
Democrat from Colorado. Similar legislation is likely to come
from the House of Representatives in coming days, one
congressional staffer said.Patient and consumer groups contend the FDA is simply not
looking hard enough to find experts, and worry loosening the
rules could jeopardize the independence of panels. They also
point out the FDA does not use up all of its allotted waivers.
By Anna YukhananovWASHINGTON, Oct 13 (Reuters) - A bill that would loosen
conflict of interest rules for advisers to the Food and Drug
Administration has been proposed by three U.S. senators seeking
to speed up review times for medical devices.The measure would reverse 2007 legislation that barred
experts who had financial ties to a company or its competitor
from serving on an advisory panel without a waiver. There is
also a limit on the number of waivers that keeps decreasing.A senior FDA drugs office official testified in August that
the agency was having difficulty in recruiting highly qualified
people for its advisory panels.The legislation also comes as medical device makers such as
Boston Scientific and Stryker have criticized
the FDA for strangling innovation with inconsistent regulation
and lagging device approvals.”The legislation would restore the appropriate balance to
conflicts of interest requirements by requiring the FDA to be
subject to the same conflicts of interest requirements as the
rest of the federal government,” according to a statement
issued by the senators.Federal regulations allow those with conflicts to serve as
advisers as long as the conflict is publicly disclosed and is
“unavoidable.”“It is critical that we don’t allow regulatory burdens to
get in the way of delivering lifesaving products to the
patients who need them,” said Senator Amy Klobuchar, a Democrat
from Minnesota. “This legislation will help ensure that we have
processes that promote safe, pioneering technologies that help
save lives and create good jobs in Minnesota.”Minnesota, home to devicemaker Medtronic , has about
30,000 jobs in the medical device industry, according to
AdvaMed, an industry trade group.Klobuchar proposed the bill along with Senator Richard
Burr, a Republican from North Carolina, and Michael Bennet, a
Democrat from Colorado. Similar legislation is likely to come
from the House of Representatives in coming days, one
congressional staffer said.Patient and consumer groups contend the FDA is simply not
looking hard enough to find experts, and worry loosening the
rules could jeopardize the independence of panels. They also
point out the FDA does not use up all of its allotted waivers.
* Captain remanded on bailBy Gyles BeckfordWELLINGTON, Oct 12 (Reuters) - The captain of a stricken
container ship wedged on a reef off a New Zealand holiday spot
appeared in court on Wednesday as fear grew the vessel may break
up spewing more fuel-oil on to beaches in the country’s worst
environmental disaster in decades.The 47,230-tonne Liberian-flagged Rena has been stranded on
a reef 12 nautical miles off Tauranga on the east coast of New
Zealand’s North Island since running aground a week ago.The captain, a 44-year old Philippine national, was remanded
on bail without plea to a charge of “operating a vessel in a
manner causing unnecessary danger or risk”, which carries a
maximum fine of NZ$10,000 ($7,810) or 12 months in prison.Prime Minister John Key said the ship’s hull was splitting.”We have identified stress fractures on the boat so we can’t
rule out the risk of the ship breaking up,” Key told reporters
on a visit to the district.The front half of the 236-metre (775-foot) ship is wedged
firmly on the reef with the stern over 90-metre (295-foot) deep
water.Heavy swells and strong winds have pounded the vessel for
two days, sending mostly empty containers tumbling off the ship,
which is listing at about 18 degrees, into the heaving seas.Weather forecasters said conditions should slowly improve
over the next two days, with wind and seas easing.Authorities said more than 30 containers have fallen off the
ship, with some of them washed up on a small island, Motiti,
about eight km (five miles) from the ship, and others bobbing in
the sea.The ship was carrying 1,368 containers, 11 of which are said
to have hazardous substances in them. Shipping using the port of
Tauranga, which is the country’s biggest export port, was being
re-routed away from the containers.Authorities said the bad weather was helping to break up and
disperse the estimated 300 tonnes of oil that escaped from the
ship.”That’s a little bit frustrating because once the oil is on
the beach we can actually deal with it, we can remove it from
the beach relatively easily,” said Ian Niblock, a spokesman for
the clean up operation.HABITATS UNDER THREATOil is scattered along 25 km (16 miles) of the district’s
long, golden beaches, which are a magnet for surfers. Nearby
waters have an international reputation for big-game fishing.Several hundred people, including soldiers, were scraping
the clumps of thick, toxic, fuel oil, some as large as dinner
plates, into plastic bags and large bins.Strong winds were blowing oil globules onto coastal roads
and a strong tar-like smell was forcing some people to wear
masks.”They say the oil could keep washing up for weeks and weeks,
that’s going to ruin this place for the summer holidays,” said
local resident Kim Greene.Key said the New Zealand government would do whatever
necessary to ensure the environment and beaches were cleaned up,
and hold those responsible to account.Booms have been placed over some harbour entrances to keep
oil out of wetland and wildlife habitats. Hundreds of dead
seabirds have been recovered and teams of naturalists have
scrubbed and treated scores more for oil contamination.”It has the potential to not only affect some of our most
pristine coastal areas … but also estuaries and already
threatened marine habitats,” said Auckland University marine
biologist scientist, Barbara Bollard-BreenThe ship’s owner, Daina Shipping, a unit of Greece’s
Costamare Inc. , and its salvage experts, are
responsible for the ship’s recovery, but any plan needs official
approval.A floating crane able to remove containers from the ship is
on its way from Singapore, but will take at least two weeks to
arrive.
