Q: What public advisory did the FDA issue regarding antidepressants?
A: The Food and Drug Administration made headlines in late March when it warned medical professionals to use caution and carefully monitor patients for whom they prescribe antidepressants. In the meantime, the federal agency is continuing to analyze data regarding a possible link between antidepressants and a vulnerability to suicidal thoughts. The FDA is encouraging the drug manufacturers of the 10 leading antidepressant prescription medicines to display warnings that the medicines may cause suicidal side effects. The FDA is, among other things, reacting to a British finding involving children, adolescents, antidepressants and suicide.
Q: Is the FDA leaving something out?
A: The American people rely on the scientists at the FDA as the front-line defenders for ensuring the safety and efficacy of prescription drugs available on the market. As consumers grow increasingly dependent on prescription drugs to improve their mental and physiological well-being, the FDA must not lose its credibility with the public. The FDA bears tremendous responsibility and ought to look for opportunities to enhance its stewardship of public health. It’s come to my attention the FDA's Office of Drug Safety may have attempted to hold back information about the possible dangers associated with antidepressant drugs used to treat youth. That’s why I’m investigating allegations regarding why the report involving the use of antidepressants in children and adults was not presented at an FDA Advisory Committee meeting in February 2004. Moreover, I want to know why its Office of Internal Affairs is investigating the question of who leaked information to the media about the report. Apparently, the FDA will not allow one of its scientists to openly discuss his findings that use of several leading antidepressants may increase the risk of suicidal behaviors among children.
Q: Why launch an inquiry?
A: Entrusted by the people of Iowa to hold government accountable, I have led a crusade during my years in Washington to conduct rigorous oversight of the federal bureaucracy. Shining a spotlight on bookkeeping at the Department of Defense, putting upper management’s feet to the fire at the FBI, keeping close tabs on the IRS and advocating family farmers’ interests at the USDA helps me to give federal agencies a reality check. We are a government of, by and for the people. To say I’ve ruffled a few feathers along the way is somewhat of an understatement. I’m not under any illusion that I’d win a popularity contest held by the federal bureaucracy. I take seriously my oath to uphold my constitutional oversight responsibilities. It takes a lot of time and effort. But I’ve found the specter of my spotlight can do an awful lot of good for the public good, including boosting the morale of rank-and-file federal workers, saving tax dollars and cutting through red tape. I’ve long followed the wisdom imparted by Justice Brandeis and believe sunshine truly is the best disinfectant. And in this case, I want to ensure the FDA isn’t violating the public trust and keeping important information swept under the rug.