WASHINGTON (AP) -- A new report says the Food and Drug Administration gives little oversight to the testing of experimental drugs and medical devices on millions of patients.
Health and Human Services Department inspector general Daniel Levinson raises questions about the FDA's ability to ensure the safety of study participants. His report says the agency inspected just one of every 100 clinical trial sites over a six-year period.
The report indicates that even when inspectors do turn up serious problems, senior officials frequently downgrade the findings. It says the problems are rarely followed by inspections to see whether the issues have been resolved.
The FDA says inspections make up only one part of its efforts to ensure participants are protected. The most important step to ensure safety, the agency says, is its review of study protocols before the trials get under way.
(Copyright 2007 by The Associated Press. All Rights Reserved.)
To comment, the following rules must be followed:
Comments may be monitored for inappropriate content, but the station is under no legal obligation to do so.
If you believe a comment violates the above rules, please use the Flagging Tool to alert a Moderator.
Flagging does not guarantee removal.
Multiple violations may result in account suspension.
Decisions to suspend or unsuspend accounts are made by Station Moderators.
Links require admin approval before posting.
Questions may be sent to firstname.lastname@example.org. Please provide detailed information.
Viewers with disabilities can get assistance accessing this station's FCC Public Inspection File by contacting the station with the information listed below. Questions or concerns relating to the accessibility of the FCC's online public file system should be directed to the FCC at 888-225-5322, 888-835-5322 (TTY), or email@example.com.