Yesterday, The Chicago Tribune published a story about a new medical study that has found a dramatic increase in adverse effects associated with prescription drugs. According to the article, "The annual number of 'serious adverse event' reports jumped to 89,842 in 2005 from 34,966 in 1998. Meanwhile, the number of 'fatal adverse drug events' increased nearly threefold to 15,107 in 2005 from 5,519 in 1998." The article also mentions the Congressional reauthorization of the Prescription Drug User Fee Act (PDUFA) and the FDA reform measures lumped in with it. The legislation renews PDUFA (a program which allows FDA to collect money from drug makers in order to conduct drug safety reviews) and expands FDA's authority to conduct post-market safety reviews and pull drugs from the market if necessary. The Senate passed its version in May, and the House approved its version in June. Because of disparities in the FDA reform provisions, a House/Senate conference committee will need to reconcile the bills before sending a final version to the president. The bill is considered must-pass legislation, because the PDUFA program expires at the end of September. While the bill must pass, findings in the medical study underscore the fundamental problems with the legislation. The PDUFA program is a double-edged sword. While it is an important source of funding for the agency, it comes with strings attached and allows drug companies to call the shots during the approval process. Moreover, by focusing only to expand FDA's powers in regard to post-market drug safety, Congress is only trying to close the gate after the horse has left the corral. When it comes to drug approval, both parts of the bill presume speed to be more important than safety. In the Chicago Tribune article, FDA spokeswoman Julie Zawisza tries to put a positive spin on the news by saying, "More reporting to us gives us more information on which to evaluate a drug's safety once it is on the market. Now that we get more reporting, people are saying that there is something wrong. We know that under-reporting is a problem so one would think that when we get more reports it could suggest that the system is actually working better but we don't for sure." Tortured logic aside, Zawisza's quote and Congress's pending legislation beg the question: Do our government leaders ever consider assuring a drug's safety before it hits the market? Reg•Watch Update: "For Congress, an Opportunity to Limit Conflicts of Interest at FDA"