There
are those whose lives have been improved for a
time by TMJ implants, but without the
bioengineering, basic and clinical studies needed
about these implants, the FDA and the patients,
will continue to not know who will have a
positive outcome, who won’t and why and if there
are device issues causing problems. The FDA needs
to have this information in order to make
decisions that will fulfill their mission – to
protect the health of the American people and we
need to have this information so that we can make
informed health care decisions. In this absence,
this is still TMJ lotto.
Right
now, there are some members of the U.S. Senate
that believe their obligation is to protect the
profitability of the medical device industry and
are devising ways to lessen the Food and Drug
Administration’s regulations – regulations that
are already inadequate to protect the public as is
demonstrated by the multitude of people that have
received not only TMJ devices that caused
harm.
The
Medical Device Regulatory Improvement
Act, which was introduced by Senators Amy
Klobuchar (D-MN), Richard Burr (R-NC) and Michael
Bennet (D-CO) that would change the FDA's device
approval process. We provide the link to the entire
bill for your reading. Items that we
especially feel should be addressed
are:
- allowing
experts with financial ties to drug or device
manufacturers to serve on FDA advisory panels as
long as they meet certain disclosure
requirements
- restricting
the FDA's ability to request more data about the
product
- restricting
the FDA's ability to evaluate off-label uses for
the device
- considering
alternative methods of evaluating safety and
effectiveness of devices in order to reduce
approval time frames and costs, and to consider
whether pre-clinical rather than clinical data
can be used to determine approval of some
devices
I
recently discussed this legislation with Marsha
Love, a TMJ Silastic implant patient who is in
need of a total joint device. Within hours and
without my asking she e-mailed a letter to
me for my opinion – a letter she intended to send
to these Senators. I thought the letter was so
“from the heart” and reflective of so many implant
patient's sentiments that I asked if we could use
it as a sample
letter for others to tailor their letter
upon.
Whether
you are in need of a TMJ device now, may need one
in the future, or simply care about those who do,
why not take the time to speak up and let
elected officials know that talking is a gift that
many TMJ patients no longer have.
We
are providing a list of the Senators on the
Health, Education, Labor and Pensions (HELP)
Committee who will be deciding this issue.
Also
listed below are the names of FDA officials. Send
them a letter with your story and
concerns.
Sincerely,
Terrie
Cowley
President
& Co-Founder
FDA
Margaret
A. Hamburg, Commissioner, FDA
Jeffery
Shuren, Director, Center for Devices and
Radiological Health, FDA
Mailing
Address: FDA, 10903 New Hampshire Avenue, Silver
Spring, MD 20993
Introduced
Legislation
HELP
Committee Members
Democrats
by Rank
Republicans
by Rank
