In the wake of the waves of criticism attacking its credibility, the US Food and Drug Administration has outlined a number of initiatives to make drug safety programmes “the best possible.”
The initiatives are the agency’s response to a set of recommendations made by the US Institute of Medicine in a hard-hitting report in September 2006, Then, the IoM claimed that a “perception of crisis" is harming the credibility of both the FDA and the pharmaceutical industry, and they are failing to communicate drug safety concerns to the public in a timely, effective manner.
That report also stated 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,
FDA Commissioner Andrew von Eschenbach said that “the extensive input we have received from stakeholders has proven invaluable as we transform the drug and medical product safety system” and the agency claimed that it had “carefully considered recent IOM recommendations, along with advice from other experts, for making needed advances in the system.”
In particular, the agency said that concrete steps should be taken in :
* strengthening the science that supports the FDA's medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management;
* improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products; and
* improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the US drug safety system.
The FDA is planning a dozen or so new initiatives, one of which would involve the use of report cards that would detail unexpected side effects that emerge after a drug has been approved. The reports would also include follow-up studies and details about how the drugs are being used.
Response to the FDA’s plans has been reasonably encouraging and Democrat Senator Edward Kennedy who, along with Republican Senator Mike Enzi, will be introducing legislation to overhaul how the FDA handles drug safety in the next few days, said that “today’s report is thoughtful and provides important recommendations for administrative action, but only legislation can give FDA the tools it needs to ensure that the agency is the gold standard for safety.”
This need for legislation was echoed by a member of the IoM panel, Alta Charo, who noted the FDA does not go as far as the institute’s recommendations, “but they are first steps and in the right direction."
