National experts and nonprofit organizations call to end FDA user fees and to improve d...( Opposition to current drug safety legi...)

National experts and nonprofit organizations call to end FDA user fees and to improve drug safety

Opposition to current drug safety legislation is growing, as a group of 22 experts on drug safety and regulation and a coalition of 12 patient, consumer, science, and public health organizations issue two separate open letters to lawmakers. The letter from FDA experts asks the lawmakers to not reauthorize the user fees system that finances the review of new drugs by the Food and Drug Administration (FDA). The letter from the coalition of nonprofit organizations calls for substantial changes to the Enhancing Drug Safety and Innovation Act introduced by Senators Kennedy and Enzi.

User fees may appear to save the taxpayer money, but at an unacceptable cost to public health, the letter from the 22 experts warns, citing findings of a panel of experts recently convened by the Institute of Medicine (IOM) to address drug safety at the FDA. They call for Congress and the nation to carefully reassess the system in which drugs are developed, tested, approved and followed post-approval, and they support replacing the current user fee model with increased direct appropriations for the FDA. The letter is also signed by drug safety expert Dr. Jerome Avorn; four IOM panel members including Dr. Bruce Psaty and Prof. Alta Charo; three former Editors-in-Chief of the New England Journal of Medicine, Dr. Marcia Angell, Dr. Jerome Kassirer, and Dr. Arnold Relman; and former Asst. Secretary for Health Phil Lee, along with other respected experts from medicine, academia, and public policy.

The letter from the coalition of patient, consumer, science, and public health organizations agrees that PDUFA is undermining patient safety, and criticizes a drug safety bill introduced by Senators Kennedy and Enzi, stating it does not include the provisions necessary to prevent another Vioxx, Accutane, or Ketek from reaching the market and harming patients and their families. The bill needs to be strengthened to protect consumers from the dangers of unreported drug risks and
'"/>

Contact: Susan Wood
eohsfw@gwumc.edu
202-994-5169
George Washington University
14-Mar-2007

Page: 1 2 3
Related medicine news :

1. National quality agenda, payment reform, care integration keys to improving quality, patient safety
2. National Academies Advisory -- June 8 public briefing on LANL groundwater protection
3. Story tips from the Department of Energys Oak Ridge National Laboratory, May 2007
4. National Autism Conference slated for June
5. National Academy of Sciences Institute of Medicine report calls for more dairy foods at school
6. Annual meeting of the National Academy of Sciences
7. National Institute of Dental and Craniofacial Research activities
8. National addiction treatment leaders to meet at first NIATx Summit
9. K-State National Agricultural Biosecurity Center director speaker at AAAS Biosecurity Symposium
10. National Inventors Hall of Fame announces 2007 inductees
11. National research network launched to seek better treatments for brain injury, stroke and seizures

Post Your Comments: