Tc
Mon, Nov-20-06, 06:15
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?D-
R_ID=32705
Daily Health Policy Report
Administration News | Senators Seek Investigation of FDA
Conflict-of-Interest Policy [Sep 22, 2005] Several senators on
Wednesday asked the Government Accountability Office to
investigate an FDA policy that allows some scientists who have
potential conflicts of interest to serve on advisory
committees, the Los Angeles Times reports (Los Angeles Times,
9/22). In a letter to GAO, Sens. Mike Enzi (R-Wyo.), Edward
Kennedy (D-Mass.) and Richard Durbin (D-Ill.) wrote, "We are
concerned about the process that supports FDA's decisions to
waive conflicts-of-interest rules for scientists with
financial ties to the manufacturers of products under
consideration or their competitors." They added, "These
practices appear to have undermined the public's faith in the
objectivity and fairness of FDA's advisory committees." The
letter cited alleged conflicts of interest among members of
FDA advisory committees that recently examined COX-2
inhibitors and silicone breast implants. FDA policy mandates
that scientists be free of conflicts of interest concerning
products they discuss for approval. However, FDA can issue a
waiver to allow such scientists to serve on an advisory
committee when their expertise outweighs the potential
conflict of interest or the financial interest is small
(Associated Press, 9/21).
***
TC
R_ID=32705
Daily Health Policy Report
Administration News | Senators Seek Investigation of FDA
Conflict-of-Interest Policy [Sep 22, 2005] Several senators on
Wednesday asked the Government Accountability Office to
investigate an FDA policy that allows some scientists who have
potential conflicts of interest to serve on advisory
committees, the Los Angeles Times reports (Los Angeles Times,
9/22). In a letter to GAO, Sens. Mike Enzi (R-Wyo.), Edward
Kennedy (D-Mass.) and Richard Durbin (D-Ill.) wrote, "We are
concerned about the process that supports FDA's decisions to
waive conflicts-of-interest rules for scientists with
financial ties to the manufacturers of products under
consideration or their competitors." They added, "These
practices appear to have undermined the public's faith in the
objectivity and fairness of FDA's advisory committees." The
letter cited alleged conflicts of interest among members of
FDA advisory committees that recently examined COX-2
inhibitors and silicone breast implants. FDA policy mandates
that scientists be free of conflicts of interest concerning
products they discuss for approval. However, FDA can issue a
waiver to allow such scientists to serve on an advisory
committee when their expertise outweighs the potential
conflict of interest or the financial interest is small
(Associated Press, 9/21).
***
TC