FDA Needs Larger Budget, Agency Science Board Says
House Energy and Commerce Committee Chair John Dingell (D-Mich.) said, "These estimates show that the president's budget has completely missed the mark in terms of what is truly needed to protect Americans," noting that the science board recommendations are seven times Bush's proposed levels (Edney, CongressDaily, 2/27).
In related news, FDA Commissioner Andrew von Eschenbach -- "in an unusual public departure from Bush administration policy" -- said in an interview that he had requested a greater funding increase for the agency than was present in Bush's budget plan. Von Eschenbach also said that the agency needs better organization to oversee drug safety and other issues more effectively. He said, "I think to do what we need to do requires substantially more dollars than what has been invested in the FDA thus far," adding that "there are issues that this agency needs to have addressed and that it's going to have to be transformed" (Wilde Mathews, Wall Street Journal, 2/27). Postmarket Oversight
Meanwhile, FDA on Tuesday announced a proposal that aims to improve postmarket oversight of prescription drugs, the Wall Street Journal reports. Announced in an e-mail to employees, the "Safety First" plan will create a new database to list the potential side effects of prescription drugs and provide a schedule for following up on questions. The agency also will revise its procedure for making certain regulatory decisions, "particularly those based on emerging safety worries, though the new moves don't go as far as some critics have advocated," according to the Journal. The plan gives new authority to the Office of Surveillance and Epidemiology, stopping "short of divorcing the two functions" of the office, which is to approve drugs and monitor for safety issues after approval, the Journal reports.
Under the plan, the office will:Implement multidisciplinary groups, including the premarket approval group and the safety office, to work together to make decisions and allow the groups to make appeals to higher-level officials in instances of disagreement;
Appoint new, dedicated officials who will be responsible for focusing on safety in each of the divisions;
Have primary authority to approve drug brand names and labeling; and
Have the authority to commission certain kinds of research, including requiring drug makers to conduct studies.The office will not have the authority to approve label changes and to remove a prescription drug from the market. Von Eschenbach said, "What we're doing is to create an integrated approach ... that isn't going to perpetuate problems of the past but really try to embrace what have to be solutions of the future."
In the future, FDA will implement a second phase of the plan, called Safe Use, which will focus on the safety of prescription drugs in real-world settings. However, there are few details available on that plan as of yet, according to an agency official (Wilde Mathews, Wall Street Journal, 2/26).
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