Panel hits FDA on health devices

[Guest guest]

M

[drugawareness] Panel hits FDA on health devices

 

 

 

More evidence that the FDA is failing miserably in its mandated

mission to protect our

nation's children.

 

Mark Miller

Web Administrator, IDFDA

 

http://www.boston.com/business/articles/2005/07/19

panel_hits_fda_on_health_devices/

 

''This report exposes a fissure in the FDA's safety mission, " Grassley

said in a statement

yesterday. "

 

Panel hits FDA on health devices

 

Report: Agency lax in monitoring safety of treatments for kids

 

By Diedtra Henderson, Globe Staff

July 19, 2005

 

WASHINGTON --The Food and Drug Administration has failed to adequately

monitor the

safety of medical devices used by children, according to a report by

the Institute of

Medicine, part of the prestigious National Academies.

 

The FDA asked dozens of companies to track the safety of devices used

by children, whose

growing bodies and active lifestyles can tax the products in ways not

studied before

approval. But the FDA could not say which studies had been completed

or whether its

requests had been ignored. And the agency rarely told the public what

it learned about

device safety, said a committee convened by the Institute of Medicine,

the federal

government's adviser on public health.

 

The panel called on the FDA to create a system to monitor the status

of device-safety

studies that are done after marketing begins.

 

Senate approves Lester Crawford as permanent FDA chief. It also asked

for ''greater

openness " through such actions as the annual reports that analyze

adverse outcomes,

including side effects associated with devices used by children. Such

a system could

involve parents reporting problems with medical devices.

 

Devices used for children include implants to improve hearing, plastic

tubing to permit

chemotherapy with fewer needle jabs, and artificial joints.

 

Among other recommendations, the panel urged Congress to strengthen

the law to permit

the FDA to require post-marketing studies. Those studies could last

longer than three

years, to take into account children's growth spurts.

 

But improved long-term monitoring must be accomplished ''without

overburdening an

often fragile industry, " Dr. Hugh Tilson, the committee's chairman, wrote.

Failures of devices used in children are remain rare, said Mark E.

Bruley, a device safety

expert among the 13 committee members.

 

If Congress, the FDA and the healthcare providers and manufacturers

who report side

effects adopt the committee's recommendations, it would ''address the

shortcomings that

we found, " Bruley said. ''Our report is not anything that should

inhibit or stifle anyone

seeking healthcare. "

 

Senate Finance chairman Chuck Grassley, Republican of Iowa, already

has vowed ''to help

improve the situation. " Last fall, Grassley held a high-profile

hearing on Vioxx after Merck

& Co. removed the troubled painkiller from the market. ''This report

exposes a fissure in

the FDA's safety mission, " Grassley said in a statement yesterday.

 

But the committee found that despite pledging an additional $3 million

in 2003 and $6

million in 2004, Congress failed to appropriate the promised funding

to bolster the FDA's

post-marketing oversight of medical devices.

 

An FDA official said an earlier internal inquiry also concluded that

the agency lacked a

standardized way to track post-marketing device studies. Those duties

have since been

transferred to the Office of Surveillance and Biometrics, which

created an automated

tracking system. The FDA plans to establish a website that would also

allow the public to

track studies.

 

''I think their criticism was fair, but this was something we had

recognized and had already

started to implement changes, " said Susan Gardner, director of the

Office of Surveillance

and Biometrics.

 

Routine devices like baby bottle nipples do not receive much scrutiny

from the FDA, but

more than half of the 80,000 medical devices sold, such as pacemakers

and respirators,

are considered higher risk. The FDA evaluates their safety and

efficacy and can order

safety studies.

 

The Institute of Medicine report, requested by Congress in 2002, comes

amid high-profile

device failures, including 100,000 defibrillators recalled by Guidant

Corp. last month and

the Indianapolis company's disclosure yesterday that 28,000 pacemakers

with faulty seals

implanted in patients may need replacing.

 

Since parents often first discover that a child's device is not

working properly, a simple

reporting system could capture their reports. Doctors and consumer

advocates are

pushing for the establishment of such a database.

 

Just 2,684 of the 151,900 side effects reported with devices in 2004

involved patients

younger than 21, but the figure is thought to be artificially low due

to under-reporting.

''If we make it easy enough, " parents will participate in such a

system, said Dr. Jon

Abramson, chairman of Wake Forest University's department of

pediatrics. ''They need to

know that by reporting it . . . they're not going to be penalized, "

Abramson said.

''That will allow us to design and make devices that are more

appropriate and better suited

for kids, " he said.

 

Diedtra Henderson can be reached at dhenderson.