The US Food and Drug Administration is to set up a new independent drug safety board, in a bid to improve openness and oversight as well as enhance independence at the agency, which has come under fire over claims it has failed to protect the public from a series of dangerous drug side effects.
Announcing the plan, which came on the eve of a three-day meeting to discuss the safety of the COX-2 inhibitor class of drugs [[01/10/04a]], Health and Human Services Secretary, Mike Leavitt, explained that the new board would oversee the management of drug safety issues, and provide emerging information to doctors and patients about the risks and benefits of medicines. “The public has spoken and they want more oversight and openness. They want to know what we know, what we do with the information and why we do it. We will address their concerns by cultivating openness and enhanced independence,” he said in a statement.
The board will oversee the management of important safety issues, such as recommending information and updates for placement on the FDA’s Drug Watch, and resolving disagreements over approaches to drug safety issues. It will be comprised of FDA members and medical experts from other HHS agencies and government departments, and will consult with outside medical experts and representatives of patient and consumer groups. As part of the proposals, the FDA also aims to improve transparency by sharing drug safety information sooner and more broadly and conveniently.
Acting FDA commissioner, Lester Crawford, said: “[The] FDA understands that the public expects better and more prompt information about the medicines they take everyday… Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise.” However, the move has met with scepticism from some parts, including New York congressman, Maurice Hinchey, who called the plan a “farce”, adding that the board would not be independent at all. “Based on what we know now, this oversight board seems to do nothing more than give doctors at the FDA new titles they can put on their business cards,” he explained. “The real problem with the FDA is that it remains far too closely tied to the pharmaceutical industry. The entire culture at the FDA needs to change and that is not something a fake ‘independent’ panel can fix,” he said.