Five leading clinicans have added their voice to criticism of the US Food and Drug Administration’s record on drug safety in an editorial published in the journal Archives of Internal Medicine.
The critics say the FDA lacks authority to fulfil its function because it cannot order drugs off the market, required label changes or issue sanctions against pharmaceutical companies that fall foul of its recommendations.
The group – all of whom are or have been members of the FDA’s drug safety and risk management advisory committee – say the agency’s current procedures mean that serious safety issues can be missed before and after approval. They recommend that a new Center for Drug Safety be set up that will operate independently from the Center for Drug Evaluation and Research in order to avoid conflicts of interest.
The critique echoes the findings of an Institute of Medicine report published last month which concluded that chronic underfunding, a lack of clear regulatory authority, a significant tail-off of FDA resources devoted to new products once they are marketed and inadequate post-approval data are harming the agency's ability to monitor newly-marketed drugs.
Congress should provide the FDA with more legal authority to pursue safety violations, create a ‘conditional’ drug approval for some drugs whose risks and benefits are not clear cut, shore up funding for drug safety monitoring programmes and reduce the numbers of experts with potential conflicts of interest on advisory committees.
Consumer advertising should also be banned for newly approved drug classes until they have been on the market long enough to detect any safety issues, they note.
More information is available on the AIM website here.