The lowdown: Funding to strengthen post-marketing surveillance has been a key theme of the debate ahead of the anticipated third reauthorization of PDUFA, through which sponsors of applications for FDA drug approval contribute user fees to the agency. Since the first PDUFA in 1992, the emphasis on the use of these fees, which currently provide around half of the total FDA funding available for drug regulation, has been on providing resources to facilitate timely review of applications. However, in the wake of high-profile drug safety issues in recent years, there have been widespread calls for funds to be directed specifically for drug safety — for example, from the Institute of Medicine in their recent report, The Future of Drug Safety: Promoting and Protecting the Health of the Public. The FDA PDUFA IV recommendations propose that annual user fee collections be increased to US$392.8 million — an increase of $87.4 million over current levels — with the biggest recommended increase of $29.3 million being earmarked for enhancing the FDA's ability to ensure drug safety. According to the agency, these funds would be used to adopt new scientific approaches and improve the utility of tools for the detection and prevention of adverse events, such as high-quality databases. In his first media interview since the Senate confirmed his appointment, FDA Commissioner Andrew von Eschenbach emphasized that better drug safety monitoring could be achieved without slowing the approval of new therapies, a sentiment that was also expressed by Jim Greenwood, President and CEO of the Biotechnology Industry Organization, in his response to the recommendations. However, FDA critics say more money is needed, and are pressing for these funds to come from taxpayers rather than the drug industry.
The lowdown: In 2004, the International Committee of Medical Journal Editors (ICMJE), which represents leading medical journals such as the New England Journal of Medicine, announced that its member journals would only consider papers reporting trial results for publication if the trial had been fully registered at its outset in an acceptable registry. Full registration requires inclusion of data that some consider to be commercially sensitive, such as outcome measures that are being evaluated. Now, just over a year after the implementation date for this policy, an editorial in the NEJM has praised a marked improvement in the quality of the data registered by industrial sponsors in ClinicalTrials.gov, the most popular public clinical trial registry (Drazen, J. M. & Zarin, D. A. NEJM 356, 184–185; 2007). The proportion of industry-sponsored trials with incomplete information listed in this registry, which is run by the US National Institutes of Health, dropped to 8% of 2,983 trials in the first 11 months of 2006, down from 26% of the 5,355 trials registered previously. Nevertheless, critics of the lack of transparency in the reporting of industry-sponsored trials seem unlikely to give up on attempts to push through legislation mandating trial registration and publication of results.
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