Navigation Links
Steven Zecola Files a Citizen's Petition with the FDA for a New Approach to Address Metastatic Cancer
Date:6/24/2013

Washington, DC (PRWEB) June 24, 2013

Cancer causes over 550,000 deaths in the United States each year 1_/, and 90% of those deaths derive from metastatic cancer. 2_/ Yet, only 8% of the federal funding for cancer goes toward metastatic cancer. 3_/

Additionally, under the FDA’s procedures for clinical trials, a new drug takes 12 years on average to make it through the FDA process 4_/ at an average cost of over $1 billion. 5_/

The burden imposed by the FDA’s rules is even greater for the compounds designed to treat metastatic cancer. First, the FDA’s rules require the compounds to reduce the primary tumor, but that is not the purpose of these compounds and they often do not pass this test. 6_/ Second, the objective of the compounds is to delay the recurrence of cancer, which by definition implies an even further elongated trial approval process and even more costs.

Nor does the FDA recognize the poor prognosis of metastatic cancer patients to establish distinct procedures for clinical trials with these participants. 7_/ Yet many of these patients have been told to get their affairs in order and many would be willing to take greater risks than others to participate in research. But the FDA applies its standard safety guidelines to the trials with these patients which cover six categories of safety including adverse events unrelated to the drug. 8_/

The Petition requests the FDA to adopt procedures specific to the circumstances surrounding metastatic cancer. For example, the trial design to ensure a compound’s efficacy would be limited to two phases. _9/

With the requested changes in place, the journey to finding a cure for metastatic cancer can begin in earnest.

The Petition can be read at: http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-0695-0001

The FDA is now accepting online comments from the public on these matters at the above location.

1_/ See, e.g., the National Cancer Institute website at: http://seer.cancer.gov/statfacts/html/all.html.
2_/ See, e.g., “Molecular networks that regulate cancer metastasis”, Spano D, Heck C, De Antonellis P, Christofori G, Zollo M., Semin at Cancer Biol. (2012).
3_/ The National Cancer Institute reports an annual budget for cancer research of about $5 billion. See: http://www.cancer.gov/cancertopics/factsheet/NCI/research-funding/print. The category labeled “metastasis” receives about $400M per year, or about 8% of the total. See: http://fundedresearch.cancer.gov/nciportfolio/.
4_/ See, for example, California Biomedical Research Association, “Fact Sheet: New Drug Development Process”, http://ca-biomed.org/pdf/media-kit/fact-sheets/cbradrugdevelop.pdf (June 2008).
5_/ See, for example, Manhattan Institute for Policy Research, “Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials”, Avik S. A. Roy, Senior Fellow (April 2012).
6_/ See, for example, Dr. Patricia S. Steeg, “Perspective: The Right Trials”, Nature 485, S58-59 (May 2012).
7_/ See, FDA: “Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf (May 2007).
8_/ See, FDA: “Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies” fda.gov/downloads/Drugs/.../Guidances/UCM227351.pdf
(December 2012).
9_/ For a discussion of the proper trial design, see Dr. Patricia S. Steeg, “Perspective: The Right Trials”, Nature 485, S58-59 (May 2012).

Read the full story at http://www.prweb.com/releases/2013/6/prweb10861402.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Director of Proteomics at the Broad Institute of MIT and Harvard, Steven Carr, to Deliver Pittcon 2014 Wallace H. Coulter Plenary Lecture
2. Representatives Betty McCollum (MN) and Steven LaTourette (OH) to Receive USGS Coalition Leadership Award
3. Ceres Expands Board of Directors with former BP Chief Scientist and Undersecretary of Energy Steven Koonin
4. Stevenage Bioscience Catalyst to Welcome Cambridge University Researchers
5. Stevenage Bioscience Catalyst Opens With Exciting Year Ahead
6. Cellular Dynamics International Files Registration Statement for Proposed Initial Public Offering
7. Dr. Rongxiang Xu, Patent Owner of Damaged Organ Regeneration, a Top Priority Addressed in the 2013 Presidential State of The Union, Files Lawsuit Against Dr. Yamanaka for Deception
8. Dr. Rongxiang Xu, Patent Owner of Damaged Organ Regeneration, a Top Priority Addressed in the 2013 Presidential State of The Union, Files Lawsuit Against 2012 Nobel Laureate Dr. Yamanaka for Deception
9. 3SBio Inc. Files Annual Report on Form 20-F for Fiscal Year 2012
10. Early Stage Drug Delivery Technologies: 62 Profiles of Start-ups and Emerging Companies
11. Regado Biosciences, Inc. Files Registration Statement for Proposed Initial Public Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... ... 2016 , ... The American Medical Informatics Association (AMIA) responded ... Coordinator for Health IT (ONC) outlining a measurement approach to interoperability that focuses ... and where it was needed. The organization of health informatics professionals said a ...
(Date:5/25/2016)... ... 25, 2016 , ... Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) ... company’s orphan drug designation request covering BHV-4157 for the treatment of Spinocerebellar Ataxia ... , Spinocerebellar ataxia is a rare, debilitating neurodegenerative disorder that is estimated ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... re-branded identity. The new Media Cybernetics corporate branding reflects a results-driven revitalization for ... and image analysis. The re-branding components include a crisp, refreshed logo and a ...
(Date:5/23/2016)... 2016 Oxitec CEO Hadyn Parry ... 10:15 a.m. ET before the United States House Committee on ... can play in controlling the spread of the Aedes ...      (Logo: http://photos.prnewswire.com/prnh/20150630/227348 ) ... self-limiting gene. Trials in Brazil , ...
Breaking Biology Technology:
(Date:3/14/2016)... NXTD ) ("NXT-ID" or the "Company"), a company ... of a new series of commercials on Time Warner Cable ... .  The commercials will air on Bloomberg TV, Fox Business ... show. --> NXTD ) ("NXT-ID" or the "Company"), ... the airing of a new series of commercials on Time ...
(Date:3/10/2016)... India , March 10, 2016 ... a new market research report "Identity and Access Management ... & Audit, Compliance, and Governance), by Organization Size, by ... to 2020", published by MarketsandMarkets, The market is estimated ... USD 12.78 Billion by 2020, at a Compound Annual ...
(Date:3/9/2016)... GARDENS, Fla. , March 9, 2016 /PRNewswire/ ... management authentication and enrollment solutions, today announced the ... DigitalPersona ® Altus multi-factor authentication platform. ... and InfoSec managers to step-up security where it,s ... Washington, DC . ...
Breaking Biology News(10 mins):