Lots happened in D.C. the week of November 14, 2011! Truth in Medicine continued its work to influence the FDA to recall and/or reclassify synthetic surgical mesh for hernia repair, pelvic organ prolapse repair and bladder suspension. Truth in Medicine was instrumental in getting both FDA Public Health Notifications issued on the serious complications of transvaginal mesh, October 2008 and July 2011.
Lana Keeton was invited to a 2 day meeting of the Union of Concerned Scientists at George Washington University (Tues/Wed, Nov 15,16th) convening a group of experts to look at the FDA right now. The event was FDA at a Crossroads. Margaret Hamburg, Commissioner of the FDA, was the keynote speaker. Day 2 was a closed session where we broke up into small groups and the "insights generated during these small-group discussions will be summarized in a white paper offering formal recommendations to government decision-makers". See link below to agenda.
Ms. Keeton attended a Congressional Hearing where Dr. Jeffrey Shuren, Director of the CDRH, testified. It was presented by the Senate HELP Committee "Medical Devices: Protecting Patients and Promoting Innovation," Tuesday, November 15, 2:30 p.m. 430 Dirksen Senate Office Building. Some of the HELP Committee attended the Capitol Hill Briefing done by Truth in Medicine May 2011.
Monday, the 14th she met with Nick Carome, M.D. at Public Citizen. Public Citizen filed a legal petition to have all mesh for POP recalled immediately and completely. She discussed her extensive reseach and gave him supporting data and information showing the incompatibility of the physical and chemical properties of synthetic surgical mesh with the human body on all levels. Our goal is to strengthen the petition so they win.
Thursday, the 17th Ms. Keeton met with the FDA/CDRH Surgical Mesh Investigative Team and presented substantial new scientific research she has done showing mesh is not inert and how mesh physically and chemically breaks down in the body and the resulting autoimmune complications from that breakdown.
The Union of Concerned Scientists and the Project on Scientific Knowledge and Public Policy at the George Washington University School of Public Health and Health Services cordially invite you to:
FDA at a Crossroads
November 15, 2011
8:30 AM – 5 PM, reception to follow
The George Washington University
Jack Morton Auditorium
805 21st Street, NW, Washington, DC 20052
As Congress prepares to debate and reauthorize the laws that govern how drugs and medical devices are evaluated, the Food and Drug Administration stands at a crossroads. The decisions of Congress regarding the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) will affect the agency’s ability to address existing and emerging challenges such as new medical technology, prescription drug and device efficacy and safety concerns, and budget limitations.
The conference aims to create a forum for experts from academia, government, patient and consumer groups and industry to exchange ideas and develop recommendations for the FDA to address these challenges. FDA officials, consumer and patient advocates, physicians, and leading academics will discuss potential reforms and the best way for the agency to use independent science in drug and medical device approval and monitoring.
FDA Commissioner Margaret Hamburg, Ph.D. will deliver the keynote address. The conference will also be webcast and remote viewers will have the opportunity to submit questions for the panelists.
Please visit the conference web page for more information on the conference and panels on Patient Safety, The Efficacy of Drugs and Devices Regulated by the FDA, Scientific Integrity at the FDA, and Institutional Challenges at the FDA.
Please feel free to contact Alex Renaud at arenaud@ucsusa.org with any questions.
LINK TO WEBPAGE FOR ABOVE:
http://www.ucsusa.org/scientific_integrity/solutions/agency-specific_solutions/fda-at-a-crossroads.html
DAY TWO INVITATION TO FDA AT A CROSSROADS CLOSED SESSION:
The Union of Concerned Scientists and the Project on Scientific Knowledge and Public Policy at the George Washington University School of Public Health and Health Services would especially like to extend an invitation to participate in the closed Day II session (November 16) of “FDA at a Crossroads.” The Wednesday session will follow the Tuesday conference and will bring experts together to discuss FDA user fees such as the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA), and other reforms and challenges ahead of the administration. Insights generated during these small-group discussionswill be summarized in a white paper offering formal recommendations to government decision-makers as they work to pass user fee legislation that benefits the health and safety of patients and consumers.
As Congress prepares to debate and reauthorize the laws that govern how drugs and medical devices are evaluated, the Food and Drug Administration (FDA) stands at a crossroads. The decisions of Congress regarding the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) will affect the agency's ability to address existing and emerging challenges such as new medical technology, prescription drug and device efficacy and safety concerns, and budget limitations.
The conference will be held at George Washington University. The closed Day II session of the conference will take place at the Weingold Conference Center on the 6th Floor of the George Washington Medical Center, located at 900 23rd St., NW Washington, DC 20037. This closed November 16 session will begin with breakfast at 8:30 AM and end at 2:30 PM.
