A newly released report from the Government Accountability Office has found that Food and Drug Administration officials dropped the ball on barring researchers who engaged in illegal actions or professional misconduct from working on future clinical trials.
FDA slow to ban rule-breakers, GAO report says
According to the report, more than half of the 18 proceedings that the FDA initiated since receiving authority to ban researchers took four or more years to complete. In at least one case, the agency took 11 years to ban an Alabama physician even though she was convicted and sentenced to five years in jail for fudging data in an antibiotic drug trial. Even in cases where the FDA did initiate timely disbarment, the agency lacked the power to prohibit drug researchers from working on medical-device trials, and had no authority at all to ban device investigators who broke the law.
“The FDA had failed to make its debarment authority work, and now the GAO report offers the latest detail of a record of the agency's weakness and failures,” said Rep. Joe Barton (R-Texas) in a news release in response to the report. Barton plans to introduce legislation that would require the FDA to bring debarment action within one year of a researcher's conviction on misconduct or criminal charges.
What do you think? Post a comment on this article and share your opinion with other readers. Submit your comments to Modern Healthcare Online at [email protected]. Please be sure to include your hometown and state, along with your organization and title.
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.