Department of Health and Human Services (HHS) Releases Report Assessing FDA’s Oversight of Clinical Investigators Financial Information

The efforts of the Food and Drug Administration (FDA) officials to screen physicians participating in patient trials of pharmaceutical drugs and medical devices, appear to be inadequate in identifying potential conflicts of interest, according to a report just released by HHS. The study reviewed 118 applications for newly approved medications from 2007 and found that 42% of the applications did not disclose complete financial information and fewer than 1% of the researchers included information regarding potential conflicts of interest.

In 1999 the FDA implemented a set of rules that required pharmaceutical and medical device manufacturers to disclose any financial conflicts that physicians involved with patient trials might have had, which also required the companies to gather the information before launching the trials and consult with the agency to address any significant conflicts. However, the rules included an exemption in which companies could forgo financial conflict disclosures if they could prove that their attempts to collect the information from the physicians were unsuccessful. According to the HHS OIG report, only 28% of the applications cited the exemption in their applications, while an additional 23% of the applications did not include the exemption or the required disclosure forms

To view the HHS study go to: http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf