PATIENT STAKEHOLDERS INVITED TO THE TABLE LATE BY THE FDA

Although I was honored to receive this invitation from Michelle McMurry-Heath, Acting Chief Scientist of the CDRH at the FDA, I would have been more honored had I received it in a timely manner so I would have been able to be there. This is a serious ongoing problem for all patients.

99.9% of what happens in Washington, D.C. that affects your health and mine happens without any input from patient advocates and patients themselves. And then it is a handful of organizations who have banded together to strengthen our position.

It seems our input is only heard when there are thousands of already severely injured patients filing adverse event reports on the MAUDE database.

Get involved and stay involved, any way you can to raise awareness patient stakeholders belong at the head of the table, not being invited at the last minute.

Best, blessings, Lana Keeton
Mesh Injured Patient
Pro Se Plaintiff who became a
Patient Advocate and a
Medical Device Expert...
Just do the work and it will get results!! :)



JOSHUA SHARFSTEIN, FDA CHIEF
SCIEINTIST & LANA KEETON
FDA-CMS SUMMIT 12-09-10







LANA KEETON & TAMARA SYREK-JENSEN
CMS, DEPUTY DIRECTOR
FDA-CMS SUMMIT 12-09-10














HERE'S THE INVITATION AND MY REPLY...I ASK THEY PAY FOR ME TO GET THERE, KNOWING THEY WOULD NOT, TO MAKE A POINT THIS IS NOT MY DAY JOB.


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

From: Lana Keeton
To: Williams, Letise
Sent: Friday, November 30, 2012 11:05 AM
Subject: Re: Announcing: “Medical Device Innovation Consortium”

Hello Mrs. McMurry-Heath and Ms. Williams,

Thank you so much for the invitation. As a patient advocate for hundreds of thousands injured by synthetic surgical mesh, I represent many patient stakeholders. Patient stakeholders take all the risk, and the benefit, of implanted medical devices and should be at the head of the table when it comes to the work of the FDA and the CDRH.

As you see, I did not receive this invitation until yesterday even though this has been in the works for almost a year. The airfare is $465.60 because of the late notice. I understand you gave a grant to the National Research Center for Women and Families in the amount of $50,000.00 for patient advocates from outside the beltway to be able to participate in this type of event. Will you provide the funds for me to be there on Monday so I will be able to represent patient stakeholders at this important event? I would really appreciate it.

Yours truly, Lana

Lana C. Keeton
Founder and President
Truth in Medicine Incorporated
1521 Alton Road, #198
Miami Beach, FL 33139
e-mail: lanakeeton@truthinmedicine.us.com
website: www.truthinmedicine.us.com
blog: www.theladyisachamp.blogspot.com

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----- Original Message -----
From: Williams, Letise
To: lanakeeton@truthinmedicine.us.com
Sent: Thursday, November 29, 2012 1:44 PM
Subject: Announcing: “Medical Device Innovation Consortium”

Greetings,

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration would like to make you aware of an upcoming event. Next Monday the independent non-profit Medical Device Innovation Consortium (MDIC) will be announcing a new public-private partnership between the MDIC, FDA, other government agencies, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues. Additional information on the MDIC can be found at http://www.deviceconsortium.org/

As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.

Please join us if you can,

Michelle McMurry-Heath
Associate Director for Science, Acting Chief Scientist
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
---------------------------------------------------------

You are invited to attend the Senate MedTech Caucus briefing:

Monday, December 3rd, 10:30 am – 12:00 pm
Room 106, Dirksen Senate Office Building

Announcing: “Medical Device Innovation Consortium”

Featuring:

FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).

The MDIC is a Public-Private Partnership (PPP) whose mission is to improve health through the application of shared knowledge in medical device regulatory science. It is the first-ever PPP created to focus exclusively on advancing medical device regulatory science.

The MDIC will create a collaborative environment where nationwide representatives from industry, non-profits, and FDA can work together to keep pace with the needs of patients in the United States.

Speakers will include:

Senator Amy Klobuchar
Senator Al Franken
FDA Commissioner, Margaret Hamburg, M.D.
FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.
Immucor, Inc., CEO, William Hawkins
LifeScience Alley CEO, Dale Wahlstrom

P.S. I BELIEVE THEY MAY ANNOUNCE THE REGISTRY FOR PELVIC ORGAN PROLAPSE MESH AT THIS EVENT. HOPE SO! WE WILL SEE!