Dated: 11/26/2010
PETITION TO CONGRESS
WE, THE UNDERSIGNED, HEREIN PETITION the Congress of the United States of America to enact, as soon as reasonably possible, legislation which would amend the Federal Food, Drug & Cosmetic Act and all other related federal statutes necessary to establish the following regarding the testing and monitoring of drugs and biologics distributed and sold within the United States:
1. PREMARKET TESTING OF DRUGS AND BIOLOGICS BY AN IMPARTIAL ENTITY.
(a) That the sponsoring pharmaceutical company would continue to design and submit the written protocols and guidelines for the intended clinical investigation of the sponsor’s drug or biologic at the time of filing the Investigational New Drug (IND) application;
(b) That once the protocols and guidelines are approved by the FDA, all future premarket clinical investigations would no longer be conducted under the direct or indirect supervision and control of the sponsoring pharmaceutical company;
(c) That a new entity would be created within the National Institutes of Health – the Clinical Investigations Institute (CII) – which upon the FDA’s approval of the study protocols would assume all supervision and control of the clinical investigations;
(d) That among its duties and responsibilities, the CII would screen and select all clinical investigators to be used in the clinical investigations, supervise the investigators during the course of the investigations, secure all patient charts, laboratory studies and other records directly from the investigators, compile all relevant data from the records and create statistics from same, and submit the CII’s statistical analysis and findings and conclusions to the FDA;
(e) That upon receipt of the investigational records and upon completion of its statistical analysis and findings and conclusions, the CII would provide copies of same to the sponsoring pharmaceutical company, which shall have the prerogative of abandoning and dismissing the IND at any time;
(f) That all personnel within the CII and all selected clinical investigators shall sign a written conflict-of-interest form representing under oath that neither they nor any members of their families have any financial or other interest in the sponsoring pharmaceutical company, which shall include criminal penalties if untruthful or in any way violated; and
(g) That one hundred percent (100%) of the cost of CII and all of its operation shall be paid for by IND user fees collected from sponsoring pharmaceutical companies.
2. ELIMINATION OF ARBITRARY DEADLINES ON NDAS AND BLAS UNDER THE PDUFA.
(a) That the deadlines of 10 months for a standard review and 6 months for a priority review of New Drug Applications (NDAs) and New Biological Applications (BLAs) under the Prescription Drug User Fee Act (PDUFA) shall be eliminated and replaced by a standard to complete “reasonably prompt” reviews of drug and biologic submissions;
(b) That a reasonably prompt assessment shall, under appropriate circumstances, entail approving a drug or biologic conditional upon completing the clinical studies postmarket, such as drugs intended for long-term use undergoing long-term clinical studies;
(c) That drugs or biologics which are intended to treat a potentially fatal condition or illness, or a condition or illness that involves severe and prolonged suffering and/or a substantial amount of medical expenses, shall be given a “priority” designation;
(d) That an NDA or BLA which receives a priority designation shall have a fast-track review, conditional upon completing the clinical studies postmarket with the same thoroughness and effectiveness of assessment as a standard review;
(e) That the user fee system under the PDUFA and current number of personnel within the drug division of the FDA shall be retained, with said user fees paying for at least 50% of the drug division’s budget, and the method of calculating said fees based upon the FDA’s determination of the amount needed to complete reasonably prompt reviews of NDA and BLA submissions and to give equal consideration to drug accessibility and drug safety;
(f) That the patent life of the drug or biologic under review shall be tolled between the date of filing the NDA or BLA and the date of final decision of the FDA on the application for market approval; and
(g) That the “sunset clause” of the PDUFA, requiring its termination every 5 years unless renewed, shall be eliminated and the PDUFA become permanent, unless later amended.
The following signators to this petition urge that Congress give full deference to their view that the above changes are in the best interests of the residents and citizens of the United States; that their intended benefits are to save lives and health care costs; and that these benefits and values far outweigh the special interests of the drug industry.
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Terence Mix, 93110
Janet Mix, 93110
Brandon Mix, 93117
Dru William Marquardt, 92088
David Giardinelli, 84115
Leonard Greene, 97062
Thomas McNamara, 95969
Al Roberson, 93110
xxxxxxxx, 48103
Harriett Friedman, 84101
Karin Hoffman, 80014
Kenneth W. Bray, 33772
xxxxxxxx, 90401
Betsy Coates, 93108
Pamela Stark, 62531
Kevin McNamara, 33410
Stephen Peritz, 33410
xxxxxxxx, 92629
Mitch Telson, 93109
Brent Hickman, 75077
Kari Bass, 93436
Joyce Kelly, 90630
Cheryl Guay, 13501
Kimberly Guay, 13501
Melvin Murphy, 28348
Mandy Beltz, 77406
Kim Baker, 77479
Michael F. Morano, 89107
Edwin J. McGrath, 16401
Carolyn Sheetz, 47562
DENNIS DARR, 28774
Barbara Duval, 37818
dian wright, 75040
Pamylle Greinke, 11958
Kit Ho, 94572
Ross LaBelle, 55074
Linda Rock, 02724
Bonnie Annis, 15827
Roxanne Esquivel, 78245
Patricia Lasek, 13304
Michael, 92081
marian davis, 21043-6033
Teresa Kaplan, 77511
Rebecca Tripp, 04974
Mike Mountjoy, 20170
Robert Shepherd, 10023
Jeannette Austin, 39525
marilyn dipalma, 86336
Mike DiPalma, 86336
michela messineo, 00040
Catherine Turley, 92869
Joseph Bongiorno, 11580
Alan Austin, 39525
Sharon Kennedy, 20101
xxxxxxxx, 27332
CINDY, 95112
moggy westfall, 10538
Kathleen Basiewicz, 28724-1204
Angelika Roll, 06033
Helen Porter, 85013
Yvonne White, 62854
xxxxxxxx, 41824
Kristy Mitchell, 76401
Mary Truelove, 46151
James walker, 5
Sioux Drabic, 90210
Henry Parlin, 04253
naoko idesawa, 20621
Edith belcher, 41265
Debbie Rubenstein, 21204
Lisa Zarafonetis, 75206
Windy Holzbach, 94142
Mary Donnelly, 2088
Henriette Matthijssen, 59427
Bruce Eyster, 11213
C Pipkin,
Mrs Mander, 12065
Carole Sarcinello, 37818
ChanTlalok Rain Castro, 78541-9402
Craig Zimmerman, 98321
Andrea Holle, 06096
Mrs. Trish Geidel, 60632
nancy sands, 11209
xxxxxxxx, 97365
june bullied, m6p 2s2
Katherine Whitson, 68102
dianne lynn elko, 15066
Aletta Kraan, 25689
Judith Pecho, 87048-9526
Ramona Thompson, 35214
Sandy Gilbert, 95014
moggy westfall, 10538
xxxxxxxx, 93449
Barbara Williams, 89110
pat myers, 12503
Barbara Williams-aka Costello, 89110
James H. Hall, 91316
Alice Diane, 08551
Caitlin Mac Iver, 04090
Dalia E. Hettfield, 90280
Gene Collatz/member/dtdn.net, 87510
Dan Williams/co/founder/dtdn.net, 89110
Janet Robinson, 33433
xxxxxxxx, 23400
nicky melville, o3953
Christine Stewart, 92026
xxxxxxxx, 37411
lkegler, 90731
Geynell Eskite, 21234-1433
Ancil 413 Southern Avenue Hattiesburg, 39401
Eddie Cheek, 37620
Natividad, 07002
Cindy M. Black, 98133
xxxxxxxx, 93110
Qais Yousef, 00692
Carole Dallek, 10007
Aleksander Lindemann, 8270
Barbara Kantola, 49120
Pat Cannell, 90210
xxxxxxxx, 11788
xxxxxxxx, 89523
faith, 38611
Peggy Acosta, 19567
Mary Hall, 80210
xxxxxxxx, 48309
xxxxxxxx, 71901
monka blanke, 3500
Dean Nydam, 93110
Brigette Nydam, 93110
David Nicewarner, 72727
Maria F., 37050
Tamila Mendoza, 90706
Larry D. Grazier, 78947
Beth, Scott & Vick Stephens And Fuller, 06615-6039
Debra Hatzias, 90277
Steve Hatzias, 90277
Eddie Cheek, 37620
Andrea Holle, 06096
xxxxxxxx, 33301
Roberto, 10705
Bill Craig, 16823
Kathy Furbush, 33702
dennis l busch, 92078
Gary F Marquardt, 95006
Marcia K Marquardt, 95006
Linda Barrett, 93110
mike hansen, 90240
Ann Pappert, 10025
Joseph Mix, 90808
Carol Stotts, 93109
Dale Hromadka, 93103
Andrew Doughty, 96746
Emilia Clark, 90808
Julie Franke, 93103
Clayton Sands, 98102
Norman Leslie, 70115
Scott Sands M.D., 75789
xxxxxxxx, 97229
Cynthia Muller, 90242
xxxxxxxx, 90242
Michael Salling, 96819
Greg Sands, 79416
xxxxxxxx, 37771
Don Staley, 48306
gregory a yates, 91436
Diana Martz, 46176
Doug Hickman, 76137
Jennifer B., 63028
Tammy Gilbert, 45251
xxxxxxxx, 27606
Matt Spurr, 93109
Melissa Burick, 92563
Deanna Zimmerman, 30315
LInda Karon, 33414
Chris Giordano, 95030
Linda Sharp, 75766
John T. Ardill, 75703
joanne denison, 60642
Maurya McCall, 19405
xxxxxxxx, 85621
Jeff Boivin, 08527
xxxxxxxx, 80863
Maria, 11780
Frank, 11780
George, 11780
Ryan Brady, 32128
xxxxxxxx, 85614
Elaine Alfaro, 95060
xxxxxxxx, 20832
Pamela Grow, 19003
xxxxxxxx, 70814
Allen Avanessian, 91214
victoria jablonski, 44138
Christina Collins, 86413
xxxxxxxx, 80232
Kevin Joyce, 01527