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Tell Senator Boxer She Did a GREAT Thing in Introducing FDA Medical Device Safety Bill!
Tell Senator Boxer She Did a GREAT Thing in Introducing FDA Medical Device Safety Bill!
Health Lover Ilena Rosenthal & The Humantics Foundation concur!
www .BreastImplantAwareness.org/
http :// ilenarose.blogspot,com
May 20, 2008
Greetings!
I'm so pleased to tell you that we have a great champion in United
States Senator Barbara Boxer of California, who late last week
introduced a bill (S.3020) to bring greater accountability and
transparency to the FDA's regulation of silicone breast implants and
all medical devices.
When the FDA approved the use of silicone implants in 2006, it failed
to live up to its mandate of ensuring that the product was safe before
allowing it to go on the market. Instead, the FDA decided to allow
manufactures to conduct post-approval studies to demonstrate the
safety of the implants once they were implanted. However, in a matter
of a few months, the manufacturers convinced FDA to change the
requirements of the studies, without any public input. And we learned
that the FDA was essentially a "toothless tiger" when it came to going
after medical device manufacturers who drag their feet or fail to
submit data from their studies. Mary and I set out to correct these
injustices by approaching Congress with our findings and Senator Boxer
responded.
S.3020 prevents FDA from unilaterally and secretly waiving or altering
a post-approval agreement with a manufacturer, without letting the
public know. The bill also gives FDA greater authority to force
manufacturers to comply with their post-marketing agreements, by
increasing fines and requiring public notification that could lead to
the removal of the product from the market.
Please send Senator Boxer a note of thanks for introducing this vital
and necessary legislation. The medical device manufacturers are a $75
billion industry with a lot of influence in Washington, D.C., so it's
very important that Senator Boxer know we support her.
The easiest and most effective way is to visit her website and simply
fill in the email form. Under the heading of "message topic" choose
"Women's issues," and under the heading of "Message Subject," type in
"S.3020 FDA Accountability and Transparency Act."
In the message box, please thank the Senator for introducing the bill.
Her bill is vital to making sure FDA and the public receive all
information necessary to make an informed decision about whether or
not medical devices are safe. And let her know that FDA needs more
enforcement authority to punish device makers who delay or fail to
disclose information.
Please alert your networks, family and friends. Encourage them to
express their support for the bill and to thank Senator Boxer.
Mary and I will be in Washington, D.C. next month and we'd love to
hear the Senator tell us about all the emails she received from in
support of the bill!
Sincerely,
Sybil Goldrich
Command Trust Network
Health Lover Ilena Rosenthal & The Humantics Foundation concur!
www .BreastImplantAwareness.org/
http :// ilenarose.blogspot,com
May 20, 2008
Greetings!
I'm so pleased to tell you that we have a great champion in United
States Senator Barbara Boxer of California, who late last week
introduced a bill (S.3020) to bring greater accountability and
transparency to the FDA's regulation of silicone breast implants and
all medical devices.
When the FDA approved the use of silicone implants in 2006, it failed
to live up to its mandate of ensuring that the product was safe before
allowing it to go on the market. Instead, the FDA decided to allow
manufactures to conduct post-approval studies to demonstrate the
safety of the implants once they were implanted. However, in a matter
of a few months, the manufacturers convinced FDA to change the
requirements of the studies, without any public input. And we learned
that the FDA was essentially a "toothless tiger" when it came to going
after medical device manufacturers who drag their feet or fail to
submit data from their studies. Mary and I set out to correct these
injustices by approaching Congress with our findings and Senator Boxer
responded.
S.3020 prevents FDA from unilaterally and secretly waiving or altering
a post-approval agreement with a manufacturer, without letting the
public know. The bill also gives FDA greater authority to force
manufacturers to comply with their post-marketing agreements, by
increasing fines and requiring public notification that could lead to
the removal of the product from the market.
Please send Senator Boxer a note of thanks for introducing this vital
and necessary legislation. The medical device manufacturers are a $75
billion industry with a lot of influence in Washington, D.C., so it's
very important that Senator Boxer know we support her.
The easiest and most effective way is to visit her website and simply
fill in the email form. Under the heading of "message topic" choose
"Women's issues," and under the heading of "Message Subject," type in
"S.3020 FDA Accountability and Transparency Act."
In the message box, please thank the Senator for introducing the bill.
Her bill is vital to making sure FDA and the public receive all
information necessary to make an informed decision about whether or
not medical devices are safe. And let her know that FDA needs more
enforcement authority to punish device makers who delay or fail to
disclose information.
Please alert your networks, family and friends. Encourage them to
express their support for the bill and to thank Senator Boxer.
Mary and I will be in Washington, D.C. next month and we'd love to
hear the Senator tell us about all the emails she received from in
support of the bill!
Sincerely,
Sybil Goldrich
Command Trust Network
