NIH gets conflict attention

The HHS Office of Inspector General's planned study of FDA's oversight of conflicts of interest for drug, biologic and device clinical investigators is on hold in fiscal 2007 pending an NIH conflict-of-interest study, Inspector General Daniel Levinson says in a recent letter to House Energy and Commerce Committee Chairman John Dingell, D-Mich. OIG expects in early 2008 to release a draft report that evaluates NIH's conflict-of-interest policies, procedures and internal investigations. FDA in March this year issued a more stringent draft guidance for determining conflict of interest and eligibility for participation in its advisory committee meetings. The proposed revisions increase the stringency of current guidance by adding a flat $50,000 threshold for financial interest in a company whose product is being reviewed by the committee (1"The Tan Sheet," March 26, 2007, p. 7). Former FDA Commissioner Lester Crawford pleaded guilty to conflict of interest and false writings charges for holding shares in firms regulated by the agency and failing to report those holdings (2"The Tan Sheet," Oct. 23, 2006, p. 5)...