Regulators and Drug Companies
Another example of why the FDA needs to clean up its act, if its going to rebuild is shakey public confidence…“Mistakes” made: FDA acknowledges Lilly phoned to question Sanjay Kaul’s inclusion on prasugrel panel
Prior to the February 3, 2009 Food and Drug Administration advisory panel hearing on prasugrel (Lilly/Daiichi Sankyo), the drug’s sponsor called the agency to question the inclusion of Dr Sanjay Kaul (Cedars-Sinai Medical Center, Los Angeles, CA) on the Cardiovascular and Renal Drugs Advisory Committee, heartwire has learned.
The agency received a phone call from Lilly on January 30, 2009, just four days before the advisory panel was scheduled to meet to discuss the risks and benefits of the new antiplatelet agent. The call was made by Lilly to staff members in the cardiovascular and renal division at the Center for Drug Evaluation and Research.
In an area as much under the ethical microscope as drug regulation, and one in which the risks of COI (for research subjects, patients, governments) are significant, it should be obvious that critical distance is necessary to avoid even apparent COI.
