Navigation Links
Justice Department Will Not Oppose CEO Roundtable on Cancer's Proposal
Date:9/17/2008

WASHINGTON, Sept. 17 /PRNewswire-USNewswire/ -- The Department of Justice announced today that it will not oppose a proposal by the CEO Roundtable on Cancer (CRC) to develop and publicize model contract language for clinical trials of potential new cancer treatments. The Department said the language is not likely to be anticompetitive and can be used to help increase efficiency in contract negotiations, potentially reducing costs and shortening the time needed to begin clinical trials.

The Department's position was stated in a business review letter from Thomas O. Barnett, Assistant Attorney General for the Antitrust Division, to counsel for the CRC.

The CRC and the National Cancer Institute (NCI) will jointly lead the project to develop model language for clinical trials. The CRC is a non-profit organization whose goal is to make continuous progress toward the elimination of cancer as a personal disease and public-health problem. The NCI is the federal government's principal agency for cancer research and training and is part of the U.S. National Institutes of Health.

The CRC requested a business review letter from the Division expressing its enforcement intentions regarding the CRC's and NCI's proposal to develop and publicize model clauses for use in clinical-trial agreements. Clinical-trial agreements typically involve three parties: a pharmaceutical or medical-device company known as a "sponsor"; a hospital, clinic, or university where the research is performed, known as the "research institution"; and the physician who is in charge of the trial, known as the "principal investigator."

"Making the model language available to sponsors, research institutions, and principal investigators, as proposed by CRC, is not likely to reduce competition," Barnett said in the letter. In the letter, Barnett explained that the "model language does not contain any provisions specifying prices or rates," and that "[w]hether to use the language or any of its provisions will be left to the determination of each party acting independently."

Under the Department's business review procedure, an organization may submit a proposed action to the Antitrust Division and receive a statement as to whether the Division currently intends to challenge the action under the antitrust laws.

A file containing the business review request and the Department's response may be examined in the Antitrust Documents Group of the Antitrust Division, U.S. Department of Justice, 450 Fifth Street, NW, Suite 1010, Washington, D.C. 20530. After a 30-day waiting period, the documents supporting the business review will be added to the file, unless a basis for their exclusion for reasons of confidentiality has been established under the Business Review Procedure.


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Baxter Awarded Pandemic Advanced Supply Contract from the Department of Health
2. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Chester County Dairy
3. U.S. Department of Health and Human Services Completes Funding of 2006 Contract Award to CSCs DVC and Baxter
4. DuPont Provides Technology for Washington Hospital Centers Emergency Department
5. NYC Department of Healths Get Some NYC Condoms Sends Wrong Message and Misuses Tax Dollars, says MIM President Bob Peters
6. PA Department of Health Reports Rise in Flu Activity; Reminds Public of Need for Flu Shot
7. Columbia University Medical Center and Rosetta Genomics Announce Columbia Universitys Submission of the First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology for Approval to the New York State Department of Health Clinica
8. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Lebanon County Dairy
9. Pediatric Heart Transplants at Montefiore Approved by NY State Department of Health
10. Deloitte and Nonprofit Roundtable Host Real-World Disaster Exercise as Next Step in Developing Preparedness Plan for Greater Washington Region
11. Jennerex Presents Clinical Data From JX-594 Demonstrating Tumor Efficacy Against Advanced Liver Cancers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/12/2017)... Kineta, Inc., a biotechnology company focused on the development of ... R&D and Head of Virology Kristin Bedard has been invited ... and Beyond meeting sponsored by Life Science Washington.  This ... AM PDT at the Agora Conference Center in ... be joined by other leaders in infectious disease research and ...
(Date:6/9/2017)... , June 9, 2017 More than ... further effort to help spread lessons learned from clinical ... International Diabetes Federation (IDF) and Eli Lilly and Company ... the second phase of the Bringing Research in Diabetes ... their commitment to helping people with diabetes effectively manage ...
(Date:6/7/2017)... , June 7, 2017 Endo International ... June 7, 2017, the Hon. Joseph R. Goodwin ... of West Virginia , entered a ... Inc. Pelvic Repair System Products Liability Litigation (the "MDL") ... MDL cases to provide expert disclosures on specific causation ...
Breaking Medicine Technology:
(Date:6/28/2017)... ... June 28, 2017 , ... Hayes, Inc., a leading ... the guest speaker lineup* for its second annual Client Symposium. Joining the symposium ... Dr. Keith Fernandez of Privia Health; and Lisa Tourville of Anthem. , ...
(Date:6/28/2017)... ... ... American Farmer proudly announces the participation of Pure Line Seeds, Inc (Pure Line ... fourth quarter 2017. American Farmer airs Tuesdays at 8:30aET on RFD-TV. , Founded in ... demand grew, the small company located in Moscow, Idaho extended its sales from Northern ...
(Date:6/28/2017)... ... June 28, 2017 , ... Designers Insurance ... communities in northern Virginia and DC, is announcing a cooperative charity event in ... Alzheimer’s and other disorders that lead to memory impairment. , The Insight Memory ...
(Date:6/27/2017)... ... ... Harbour , a DAO (decentralized autonomous organization) that harnesses the wisdom of ... technical specifications . , 2017 has seen an explosion of token launches by blockchain ... will garner the greatest ROI. Dean Eigenmann, Co-founder and CEO of Harbour, said, “We ...
(Date:6/27/2017)... (PRWEB) , ... June 27, 2017 , ... A January ... been projected to reach a staggering $6.81 billion by the year 2024 according to ... at a faster rate than those made from titanium. Los Angeles area clinic Beverly ...
Breaking Medicine News(10 mins):