FDA Lax On Examining Potential Conflicts Of Interest In Drug Trials, HHS OIG Report Says

Main Category: Clinical Trials / Drug Trials
Also Included In: Regulatory Affairs / Drug Approvals;  Public Health
Article Date: 13 Jan 2009 - 3:00 PDT

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The efforts of FDA officials responsible for screening physicians involved in patient trials of pharmaceutical drugs and medical devices, as part of the agency's product approval process, appear to be inadequate in identifying potential conflicts of interest, according to a report released on Monday by the HHS Office of the Inspector General, the AP/Austin American-Statesman reports. For the study, investigators examined 118 applications for newly approved medications from 2007. The study 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 (Alonso-Zaldivar, AP/Austin American-Statesman, 1/12).

Of the 1% who did disclose a potential conflict of interest, nearly all disclosed just one financial interest, according to the study. The study also found that in 31% of the applications that included the required disclosures, FDA reviewers failed to state that they had examined the information. In 20% of the applications in which disclosures were made of significant financial conflicts, reviewers from FDA and the sponsoring companies did not do anything to address the conflicts, the study found (Harris, New York Times, 1/12).

The report stated, "We found a number of limitations in FDA's oversight, leaving FDA unable to determine whether (drug companies) submit financial information for all clinical investigators." The report added that such limitations "could result in FDA being unaware of a clinical investigator's financial interest, and thus unable to gauge its potential bias on clinical trial results." According to the AP/American-Statesman, the "issue is not scientists' compensation for supervising drug development tests but the conflicts that could arise from other rewards, such as honoraria, grants and stock options" (AP/Austin American-Statesman, 1/12). The report called on FDA to improve its conflict of interest oversight procedures, enforce the financial disclosures policy for companies, ensure that reviewers examine the disclosures, and conduct the oversight before patient trials are launched.

Exemption
According to the New York Times, FDA in 1999 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.

Response
Karen Riley, a spokesperson for FDA, said the agency disagreed with the report's recommendation to review physicians' financial conflicts ahead of patient trial because they are only one possible source of bias. FDA also said that the effort to collect and examine the information was not beneficial to the agency or the companies involved (New York Times, 1/12).

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