Show FDA Creates Board to Screen Drugs on Market Ricardo Alonso- Alonso Los Angeles Times The Food and Drug Administration responding to concern about dangerous side effects in drugs it approved for use by millions of consumers said Tuesday that it would create a new safety board to better protect the public The new Drug Safety Oversight Board staffed primarily primarily primarily marily by FDA and other government scientists but receiving help from outside experts as well is to focus on spotting and responding quickly to signs of problems with drugs that have been approved for market Board members will have direct access to the FDA commissioner commis commis- A Web page meantime will be created to help transmit transmit transmit trans trans- mit early warning information information information tion to researchers doctors and patients The announcement of the safety measures marked a turn in the Bush administrations administration's administrations administration's administrations administration's tion's effort to deal with an increasingly profile high-profile problem It came one day before a major scientific conference was scheduled to begin examining several widely prescribed drugs that turned out to have dangerous side effects The conference is expected to produce recommendations recommendations that could have reaching far effects for tens of millions of patients as well as for billions of dollars in drug industry revenues In particular the focus of the three-day three conference willbe willbe will willbe be on a class of painkiller drugs called COX 2 inhibitors which includes and Also possible risks of the active ingredient in will be considered Some members of Congress and outside critics said that the steps announced Tuesday did not go far enough The agency has come under mounting public pressure in recent months after one of its own scientists and several outside experts See FDA continued on page 2 FDA continued from front spotlighted its failure to act quickly act quickly on evidence on-evidence of problems with approved C drugs Senior federal officials appeared to recognize that more sweeping changes would have to follow Health and Human Services Secretary Michael Leavitt announcing announcing announcing ing the plans in a speech to FDA employees said his ultimate goal is nothing less than a transformation of their agency to instill a a culture of openness an enhanced sense of independence independence inde inde- p. p anda a d dj commit commitment Q t ment ment To to monitor monitor drugs drugs aft after after- r they h have ve- ve been been- approved Acting FDA Commissioner Lester M. M Crawford said the agency m must st change an existing culture that has placed a high priority on not alarming alarming alarming alarm alarm- ing the public when warning warning warning warn warn- ing signs pop up When we pet get et a signal 0 0 we eve find that in the majority of cases it was a false signal signal signal sig sig- nal Crawford said explaining the FDA's traditional traditional traditional reluctance to publicize publicize publicize cize early signs of trouble with approved drugs But Buthe Buthe Buthe he added That era has passed What the public is demanding is to know as soon as we know Our system can best be described as a passive system system system tem Crawford said relyn rely- rely n n drug gro makers S to report potentially dangerous dan problems The government must play a more active role in spotting and responding to signs of trouble he said Officials said they would move quickly to put the new safety measures in place No information was provided on costs Rf tn to the announcement announcement of the new safety board and the Drug Watch site on the Web some members of Congress and oth other r critics said more reaching far-reaching reforms were needed This is a step in the right direction but it doesn't doesn't doesn't does does- nt go nearly far enough said Sen Christopher Dodd D Consumer confidence in inthe inthe the FDA has been shaken toJ to the f core and it more than c cosmetic reforms to fix structural problems within the agency Sen Charles E. E Grassley R-Iowa R said he would move ahead with f legislation to create an independent drug safety office and establish a public pub pub- J lic registry for clinical tri- tri nto 1 t h. h a. a u UJ u UA u Ug manufacturers Much more needs to be bedone bedone done to strengthen FDA's ability to address drug safety said Rep Henry D The agency needs to have additional additional additional addi addi- J resources additional authority and strong leadership leadership lead lead- leadership at its helm |