Fw: URGENT Congress may pass bill to weaken implant safety!

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----- Original Message -----

From: " Ilena Rose " <ilena@...>

<Recipient List Suppressed:;>

Sent: Saturday, March 23, 2002 1:34 PM

Subject: URGENT Congress may pass bill to weaken implant safety!

> From: " Zuckerman " <dz@...>

>

>

>

> Dear Friends,

>

> Many of you have had bad experiences with implants. I am writing to

> urgently inform you that there are efforts underway in the House of

> Representatives to pass legislation that would make it even easier for

> defective devices to be sold in the U.S.

>

> A sample letter is below, for those of you who might be interested in

> writing to your own member of Congress. It is not worth your time to

> write to anyone who is NOT your own member.

>

> Any of you who live in the district of Rep. Jim Greenwood (PA) or

> Eshoo (CA) are especially urged to contact them. However, all members

> need to hear from you.

>

> There is currently no Senate version of this bill, but there will be

> soon. Any of you from Connecticut should contact Ms. Deb Barrett from

> Sen. Dodd's office to express your concerns.

>

> This legislation is moving fast, so please take the time to write today,

> either e mail or snail mail.

>

> If you neen help identifying your Congressional representative, go to the

> House of Representatives website for help, or contact Celine at our

> office at cc@....

>

> Sincerely, Zuckerman, Ph.D.

> President

> National Center for Policy Research (CPR) for Women & Families

> 1901 Pennsylvania Avenue, NW

> Washington, DC 20006

> 202 223-4000www.center4policy.org

>

> The Honorable ________U.S. House of RepresentativesWashington, DC 20515

>

> Dear Rep. ____:Implanted medical devices, such as heart valves and hip

> replacements, are not adequately studied for long-term safety before they

> are approved by the FDA. I am very concerned that the Medical Device

> Amendments of 2001, H.R. 3580,

>

> introduced by Rep. Jim Greenwood and Rep. Eshoo, undermine FDA's

> ability to make sure that medical devices are safe before and after they

> are approved for sale.

>

> The recent delay in the recall of defective Olympus bronchoscopes, which

> resulted in several deaths, is an important reminder that we need to do

> more to improve safeguards for medical devices. The manufacturer

> apparently knew that the defect could be potentially fatal for two months

> before announcing a recall, and even then the recall was so quiet that

> s Hopkins Hospital and other medical facilities were unaware of it,

> and continued to use the defective device.

>

> My own experience with a defective implant has caused my concern about

> the FDA's failure to monitor the long-term safety of medical devices.

> The FDA should be required to closely monitor, document,

>

> and audit all medical device Phase IV trials, which are the studies

> required after a product has been approved. The studies should be

> monitored to make sure that patients receive informed consent, make sure

> that the study is designed and conducted properly, and make sure that the

> results are reported accurately.

>

> Because of my personal experiences, I strongly urge you to oppose the

> Medical Device Amendments of 2001, H.R. 3580. The medical device

> industry has been lobbying Congress to de-regulatedevices, and this bill

> represents their wish list.

>

> The goal of H.R. 3580 is to speed up approvals, rather than to make sure

> that medical devices, especially implanted devices, are safe for

> long-term use.

>

> H.R. 3580 ignores the need for improved post-market surveillance.H.R.

> 3580 sets new time limits on reviews of medical device safety. This

> would be an unfunded mandate that will divert resources from FDA's other

> safety and regulatory responsibilities.H.R. 3580 includes a Device

> Fellowship Program that would introduce temporaryemployees to review

> medical devices. FDA needs experienced reviewers, not temporary staff

> who will go on to jobs in industry.

>

> H.R. 3580 permits non-FDA " outside experts " to review 510(k)

> applications, and the use of non-FDA " accredited persons " to conduct

> inspections of medical device facilities.

>

> Manufacturers would have the authority to choose and in some cases to pay

> for these experts, which creates a clear conflict of interest. -- the

> fox guarding the hen house.H.R. 3580 restricts the circumstances under

> which the FDA can inspect medical device facilities, which would

> undermine safety. As a consumer and a constitituent, I urge you to oppose

> the Medical Device Amendments of 2001, either as a bill or as an

> addition to other bills. I understand that efforts are underway to

> attach provisions of this dangerous bill to either the Prescription Drug

> Users Fee Act (PDUFA) or the Bioterrorism bill. Please vigilantly oppose

> any such efforts, and let me know of your plans to do so.

>

> Sincerely,

>

>