A top Republican senator on Monday called for Congress to give the Food and Drug Administration more power to review drugs after they are approved for the public, citing a government report that found lingering safety concerns at the agency.Great—the freedom to make medical choices for one’s self now looms even more distant.
The report, conducted by the Government Accountability Office, said there is no clear process for the FDA to monitor products once they are sold and that the agency should have the authority to require additional, post-approval studies from drug manufacturers.
"This report identifies the kinds of problems I've been tracking and investigating for the last two years," said Senate Finance Committee Chairman Charles Grassley, who released the report. "The FDA needs to make big changes."
The Iowa Republican requested the GAO review in late 2004 after Merck & Co. Inc. recalled its arthritis pill Vioxx because of links to heart problems.
The FDA has also been criticized for its handling of other safety issues, including antidepressant use among children and teenagers amid evidence it may cause suicidal behavior.
"FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues," the GAO report said. "We observed that there is a lack of criteria for determining what safety actions to take and when to take them."
The FDA sometimes approves products under the condition that companies later provide more data, but it lacks the authority to require such studies in most cases. The GAO said longer trials after approval could "answer safety questions about risks associated with the longer-term use of drugs." [Susan Heavey, Reuters]
I have a bold idea: why not simply recognize that people must be responsible for their own choices, including what medicines they are to take? One suspects that such a view runs counter to Sen. Grassley’s theory of government; after all, Iowa is a state so fat off of government subsidies to agriculture (which are predicated upon the idea that the American farmer is incapable of running a profitable farm and thus must be rescued from both himself and the market) one wonders if Grassley and his electorate had an independent brain cell between them all.