The US Food and Drug Administration needs more authority to enable it to compel companies to change drug labels quickly when safety concerns arise, Sandra Kweder, deputy director of the agency’s office of new drugs, told Congress yesterday, according to Industry reports.
“We don’t have the authority to tell a company: ‘This is how your label has to look’,” Dr Kweder is quoted by Bloomberg as telling the Senate Committee on Health, Education, Labour, and Pensions at a meeting yesterday. She explained that the agency must negotiate the specific wording for all label changes with the pharmaceutical company in question, and that it does not have the authority to dictate the changes to them.
The HELP committee is holding a series of hearings this week to assess the FDA’s drug approval process as part of what Massachusetts Senator, Edward Kennedy, who is a member of the committee, was the first part of a “comprehensive response to the public’s concerns about the FDA and drug safety.”
A second hearing has been scheduled for tomorrow, which will examine the steps the FDA is taking to address public concerns about the safety of prescription medicine, as well as evaluating the agency’s ability to handle the challenges it will face in meeting its mission in the future. The agency has come under increased scrutiny since Merck & Co withdrew its painkiller, Vioxx (rofecoxib), after it was linked to an increased heart attack risk [[01/10/04a]], even though safety concerns first came to light as early as 2001 [[09/02/01a]].
However, Senator Mike Enzi, chairman of the HELP committee cautioned: “We should not try to reinvent the wheel and develop a system that aims for an impossible standard of zero risk.” However, he went on to say: “We must weigh the benefits and risks on the same scale… Attempting to achieve a zero safety risk would block millions from benefiting from life saving drugs and therapies.”