Obama Faces a "Fundamentally Broken" FDA

ALICIA MUNDY and JARED A. FAVOLE, of the Wall Street Journal, write that: "A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law. The nine scientists ... say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal." The letter includes a passage that reads: "There is an atmosphere at FDA in which the honest employee fears the dishonest employee." The nine scientists focus their concerns on the scientific procedures used to review medical apparatuses that they say has been "corrupted and distorted by current FDA managers, thereby placing the American people at risk." A spokesperson for the agency has explained that the FDA is "actively engaged in a process to explore the staff members' concerns and take appropriate action." Commissioner Andrew von Eschenbach and Bill McConagha, the assistant commissioner for accountability and integrity have been contacted by the nine scientists. The Wall Street Journal reporters say: "The agency has been under fire from both parties in both Houses of Congress as being too close to industry. Several leading politicians, including Sen. Chuck Grassley have complained that FDA leaders often ignore or suppress their own scientists' opinions on safety issues involving drugs and devices. Those concerns were also aired in a report by the National Academy of Sciences' Institute of Medicine in 2006. FDA leaders, including drug division chief Janet Woodcock, have said they are working to improve the culture at the FDA, and are listening to dissent from their experts and doctors." The nine scientists have expressed their hopes that the FDA's current leaders are quickly replaced by the incoming Obama Administration. The nine scientists "says the FDA approved such devices without clinical evidence showing they were effective in detecting breast cancer. Since 2006, FDA physicians and scientists have recommended five times that these devices not be approved without valid scientific and clinical evidence. The group said there needs to be a complete restructuring of the evaluation and approval process, and that Mr. Obama needs to sign new legislation giving protection to government employees who speak out against corruption." The untenable situation at the FDA reflects poorly on the conduct of the Bush Administration when it comes to oversight of FDA procedures regarding medical devices. The most important of several questions looming over the FDA's disregard for established scientific procedures is whether the actions of the leadership were intentional or a matter of gross misconduct.