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:10/11/2017)...  BioPharmX Corporation (NYSE MKT: BPMX) researchers were part ... way to use nonlinear optical imaging to confirm the ... A presentation ... how researchers from BioPharmX and the Wellman Center for ... suite of imaging techniques in what is called "Pharmacokinetic ...
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
(Date:10/10/2017)... Oct. 10, 2017  NDS received FDA 510(k) clearance in May ... battery-powered display stand specifically designed for endoscopy environments. An innovative secondary ... a clinical solution to support the improvement of patient outcomes, procedural ... ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... that offers insurance and financial preparation services, is providing an update on a ... organization. , Rock City Rescue is a locally recognized nonprofit that provides shelter ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... PurhealthRX ... CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will ... and providing a CBD form that can be easily incorporated into liquid products, while ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association ... Featuring a collection of specialty vendors and unique items from across the nation, this ... health and wellness services offered by the VNA. The boutique will be open ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... ... ... Planet Fitness, one of the largest and fastest growing franchisors and operators ... location in Covington, LA at 401 N. U.S. Highway 190, in January of 2018. ... in the Holiday Square shopping center. Its location allows it to serve both Covington ...
Breaking Medicine News(10 mins):