Editorial Addresses Report On FDA Conflict Of Interest Screening Efforts

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Primary Care / General Practice;  Pharma Industry / Biotech Industry;  Clinical Trials / Drug Trials
Article Date: 14 Jan 2009 - 3:00 PDT

email to a friend   printer friendly   opinions  

FDA "has distressingly limited interest" in addressing the "rising concern that conflicts of interest may bias the outcome of clinical trials," a New York Times editorial states. The editorial continues that a report released on Monday by the HHS Office of Inspector General on the efforts of FDA officials to identify potential conflicts of interest "found appalling failures" by the officials "to collect information and act on it"

FDA accepted most of the recommendations but "complained" that reviewing financial information prior to the start of trials "would increase its workload for no clear gain, especially since many drugs or devices that enter clinical trials never reach the market," the editorial states. According to the Times, "Such bureaucratic excuses seem lame," adding, "Surely it would be better for [FDA] to eliminate potential conflicts before they can bias a trial than try to mitigate them after the results are in." The editorial concludes that FDA's "lax performance underscores the need for Congress to pass legislation requiring all drug and device makers to report their financial arrangements with doctors in a public databank," adding, "That would make it harder for clinical investigators or sponsoring companies to hide potential conflicts, including those that might bias clinical trials for the FDA" (New York Times, 1/13).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

• Additional
• References
• Citations