See "The United States faces a “mounting public health crisis in drug safety, and definitive action must be taken” to revitalise the Food and Drug Administration, said Jeffrey Drazen, editor of the New England Journal of Medicine in an editorial that was also signed by two of the journal’s senior editors.
The FDA has been politicised, and “this trend must be stopped,” says the editorial, which was published online on 9 October (www.nejm.org, doi:10.1056/NEJMe068237). The FDA’s decisions about the nation’s drug supply “should be based solely on scientific evidence.”
The FDA has “critical issues of financing, transparency, and independence,” the editorial says. A report by the Institute of Medicine released last month calling for major changes to the FDA (BMJ 2006;333:673) “is a critical starting point, and we urge Congress to implement its recommendations and give them the highest priorities.”
Also published online is an article by Sheila Burke, who chaired the committee of the Institute of Medicine that produced the report, and Bruce Psaty, a member of the committee (doi:10.1056/NEJMp068228).
Monitoring of safety of drugs after they have been approved needs to be improved, Dr Drazen and his colleagues say. The FDA’s Center for Drug Evaluation and Research gets more than half its funds from drug industry fees, the institute’s report said, and the centre spends much more on the approval process than on post-marketing surveillance. It would be better, the report concluded, if the centre’s funding came from general appropriations and some of the fees paid by drug companies were used for post-marketing surveillance.
Other conclusions of the report were that doctors and patients need better information about adverse events associated with drugs and that new drugs should carry a black triangle (as in the UK) to show that safety information is incomplete. Companies should not be able to advertise new drugs to the public for two years after they have been approved.
All clinical trials beyond phase I should be registered in a public database.
In their article Dr Burke and Dr Psaty strongly criticise the FDA. Its prohibition of the use of drug company fees for post-marketing surveillance has led to the US being “the country of first launch, the public testing ground, for many new drugs.”
Among the FDA’s “serious problems” are a “lack of clear regulatory authority, chronic underfunding, organisational difficulties, and a scarcity of post-approval data,” their article says, as well as a suboptimal work environment, a lack of consistency among the divisions of the Center for Drug Evaluation and Research, polarisation between the offices responsible for the pre-marketing review and post-marketing surveillance of drugs, management disregard and disrespect for scientific disagreement, and politicisation of and a lack of stability in the office of the FDA commissioner.
The FDA needs “an integrated package [of reforms]—not a menu of options,” Dr Burke and Dr Psaty say.