| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
Correspondence |
Duke University Medical Center, Durham, USA, E-mail: staff002{at}mc.duke.edu
Dr. McConachie highlights many important additional issues regarding the current low confidence (internationally) in the safety evaluation process as part of drug development that was reviewed in the recent issue of the Journal.1 These concerns exist not just for COX-2 inhibitors and, as pointed out in the letter, the line is blurred where acceptable side effects merge with unacceptable safety issues (e.g., gastrointestinal bleeding with aspirin). While the COX-2 inhibitor story continues to develop,2 national institutions charged with drug development are beginning to respond. Subsequent to publication of the editorial, a report from the United States Food and Drug Administration lists eight major problem areas and makes five recommendations to improve drug safety evaluation.3 The proposed reforms focus upon empowering the agency with legislation, expertise and funding, and improvements in the process of drug safety review, including instituting a "conditional approval" or probationary period, that would place expectations on the company for completion of required studies before full endorsement. The European Medicine Evaluation Agency is contemplating a similar one-year conditional approval, while France, Japan and Norway have instituted two and four-year post-approval safety reviews for all drugs.3 Hopefully, public health and public trust will be improved by these changes in the drug development process.
References
1 Stafford-Smith M. Hurry up and slow down: Lessons in drug development from the COX-2 inhibitors/Se hater et ralentir: les lecons a tirer de la production des inhibiteurs de la COX-2. Can J Anesth 2006; 53: 973–7.
2 Furberg CD. The COX-2 inhibitors--an update. Am Heart J 2006; 152: 197–9.[Medline]
3 Furberg CD, Levin AA, Gross PA, Shapiro RS, Strom BL. The FDA and drug safety: a proposal for sweeping changes. Arch Intern Med 2006; 166: 1938–42.
Related articles in CJA:
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
