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Financial disclosure of clinical investigators has also become a focal point

  • On January 12, 2009, the HHS OIG issued a report that was deeply critical of FDA’s oversight of clinical investigators’ financial disclosure

  • Under FDA’s financial disclosure regulation (21 CFR Part 54), investigators and study sponsors must submit to FDA information about investigators’ financial interests

  • Among other things, the OIG found the following:

    • 42 percent of FDA-approved marketing applications were missing financial information

    • FDA did not document a review of financial information for 31 percent of marketing

applications

    • Neither FDA nor sponsors took action for 20 percent of marketing applications with disclosed financial interests

  • FDA may start reviewing financial disclosure forms during clinical site and sponsor inspections

  • In response to the OIG Report, Sen. Charles Grassley and Rep. Maurice Hinchey indicated that they would re-introduce legislation to address investigator financial interests and to require drug companies to publicly report payments to physicians

© 2009 Hogan & Hartson LLP. All rights reserved.

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