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Report Suggests FDA Should Improve Oversight of Doctor Conflicts

By Greg Webb

The Food and Drug Administration needs to improve its oversight of the financial conflicts of doctors who participate in clinical testing before a drug is approved for sale, according to a government watchdog report.

The FDA lacks a complete list of doctors conducting research on new medicines, and it cannot determine which companies have submitted financial information for doctors working on studies, according to a report by the Department of Health and Human Services inspector general.

Of the 118 marketing applications of medicines or medical devices approved in 2007 which were examined by investigators, 42 percent of the applications lacked financial information, and 31 percent of the applications had no documented review of any financial data.

The report urged the FDA to take steps to ensure companies submit complete financial information, and that the submissions are reviewed by the agency. It also said that the FDA should require companies to submit doctors’ financial information before clinical trials on humans begin.

While the FDA agreed with most of the report’s ideas, it rejected the last, saying it “could have the unintended effect of adding to the complexity and cost of the clinical trial enterprise with no commensurate gain in the protection of human subjects or the quality of data.”

Once more, it sounds as if the medical device manufacturers and pharmaceutical companies are, through big money, controlling or deeply influencing governmental decisions and oversight. This has also occurred with the Consumer Product Safety Commission (CPSC) and the auto industry, as one example. When the fox watches over the henhouse, something is wrong. I cannot imagine how the costs of such oversight would so dramatically impact the “complexity and cost of the clinical trial enterprise” so as to outweigh associated benefits of helping to prevent defective medications or medical devices from being too readily and quickly approved for public consumption. Perhaps I am too cynical.

Originally posted at InjuryBoard by Greg Webb

Full post as published by Charlottesville Personal Injury Lawyer on January 27, 2009 (boomark / email).