UPDATE: FDA Seeks Tighter Accuracy For Diabetes Devices
September 17 2009 - 4:28PM
Dow Jones News
The U.S. Food and Drug Administration wants blood-sugar
monitoring devices used by diabetics to be more accurate, according
to its commissioner.
The FDA has asked an international standards-setting body to
toughen accuracy requirements for home-glucose monitors. The agency
says it believes the current standard is too lax because it allows
inaccuracies of up to 20% in the devices. Diabetics use the devices
to determine whether their blood-sugar levels are unsafe and they
require medication.
"If we're unable to convince the international community to
tighten the accuracy standards for glucose meters," the FDA may
pursue "higher performance standards ourselves," FDA Commissioner
Margaret Hamburg said in a speech at a conference of
regulatory-affairs professionals in Philadelphia on Wednesday.
Hamburg said the devices have generally been effective in
managing diabetes since their introduction in the 1970s. But she
asserted there haven't been any significant improvements in
accuracy over the past decade because manufacturers are content to
meet the international standard, set by the International
Organization for Standardization, or ISO, a non-governmental
organization based in Geneva.
Johnson & Johnson (JNJ), Abbott Laboratories (ABT) and other
companies make the devices. J&J doesn't break out the products'
sales, but they are part of its diabetes-care franchise, which had
$2.5 billion in sales last year. Abbott's diabetes-care unit had
$1.35 billion in sales last year.
Dave Detmers, spokesman for J&J unit LifeScan, said Thursday
that the company is working with other manufacturers, regulators
and doctors to review the accuracy standards for glucose monitors
and determine whether changes are needed. LifeScan's OneTouch
products have exceeded the ISO criteria for the past seven years,
he said. If standards are changed, LifeScan would work to ensure
its products meet or exceed them, he added.
Abbott also is working as part of the international group
reviewing accuracy standards for blood-glucose meters, said
spokesman Greg Miley. He said the company will continue to meet
current and future regulatory standards that may be put into place
for the devices.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com