Petition

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.

Please Note: YOUR EMAIL ADDRESS WILL NOT BE VISIBLE TO THE PUBLIC!

Name:

E-mail address:

Zip Code:

Do not display name on website:

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