From the current edition of FDA News ...
Experts Question Effect of FDA's New Office of Integrity and Accountability
by Christopher Hollis
FDA Commissioner Andrew von Eschenbach's establishment of a new Office of Integrity and Accountability to address cultural issues within the agency might be a "nice" idea but is not necessary for accomplishing the FDA's mission, according to Peter Pitts, director of the Center for Medicine in the Public Interest (CMPI).
The initiative is just "placating critics on Capitol Hill" and could divert resources away from the FDA's mission, Pitts noted. It is wrong for politics to drive agency policy, Pitts said.
Von Eschenbach announced the creation of the new office during PhRMA's annual board meeting March 15.
However, CMPI Vice President Robert Goldberg said that the creation of the office was a good move for the FDA. "I think what von Eschenbach is trying to do is bring some order to the frat house."
"What he is doing, I think, with this office is giving people who have a grievance or feel that they've been side-stepped an opportunity to . vent and formally present their case to the commissioner, instead of having it fester as some kind of internal squabble within the ranks." That's a smart idea, he added, "and the right thing to do, rather than taking it to Congress where the data and the claims go unfiltered right to the media."
One of the issues the new office will handle is managing conflicts of interest for advisory committee members. Pitts, who dealt with advisory committee issues while serving during the first term of the Bush administration as the FDA's associate commissioner for external relations, noted that restrictive policies regarding conflicts of interest for committees are not conducive to retaining the best and the brightest scientists.
Instead of the best and the brightest, you get "almost the best and kind of the brightest," Pitts said. Goldberg echoed Pitts' sentiment regarding restrictive conflict of interest policies, specifically those set forth by the Institute of Medicine and in S.484, the "Enhancing Drug Safety and Innovation Act of 2007," introduced by Sens. Edward Kennedy (D-Mass.) and
Mike Enzi (R-Wyo.).
"It's ridiculous. People who have won Nobel prizes in pharmacology or medicinal chemistry would have been excluded [as members], both by the recommendations made by the Institute of Medicine and by the standards set forth in [S.484]," Goldberg said.
Experts Question Effect of FDA's New Office of Integrity and Accountability
by Christopher Hollis
FDA Commissioner Andrew von Eschenbach's establishment of a new Office of Integrity and Accountability to address cultural issues within the agency might be a "nice" idea but is not necessary for accomplishing the FDA's mission, according to Peter Pitts, director of the Center for Medicine in the Public Interest (CMPI).
The initiative is just "placating critics on Capitol Hill" and could divert resources away from the FDA's mission, Pitts noted. It is wrong for politics to drive agency policy, Pitts said.
Von Eschenbach announced the creation of the new office during PhRMA's annual board meeting March 15.
However, CMPI Vice President Robert Goldberg said that the creation of the office was a good move for the FDA. "I think what von Eschenbach is trying to do is bring some order to the frat house."
"What he is doing, I think, with this office is giving people who have a grievance or feel that they've been side-stepped an opportunity to . vent and formally present their case to the commissioner, instead of having it fester as some kind of internal squabble within the ranks." That's a smart idea, he added, "and the right thing to do, rather than taking it to Congress where the data and the claims go unfiltered right to the media."
One of the issues the new office will handle is managing conflicts of interest for advisory committee members. Pitts, who dealt with advisory committee issues while serving during the first term of the Bush administration as the FDA's associate commissioner for external relations, noted that restrictive policies regarding conflicts of interest for committees are not conducive to retaining the best and the brightest scientists.
Instead of the best and the brightest, you get "almost the best and kind of the brightest," Pitts said. Goldberg echoed Pitts' sentiment regarding restrictive conflict of interest policies, specifically those set forth by the Institute of Medicine and in S.484, the "Enhancing Drug Safety and Innovation Act of 2007," introduced by Sens. Edward Kennedy (D-Mass.) and
Mike Enzi (R-Wyo.).
"It's ridiculous. People who have won Nobel prizes in pharmacology or medicinal chemistry would have been excluded [as members], both by the recommendations made by the Institute of Medicine and by the standards set forth in [S.484]," Goldberg said.
