The Pharmaceutical Medicine Year that Was
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COMMENTARY
© 2008 Adis Data Information BV. All rights reserved.
The Pharmaceutical Medicine Year that Was A View from San Diego, California, at the End of 2008 Anthony W. Fox Consulting Editor, Pharmaceutical Medicine
Last year, it was confidently predicted that 2008 at the US Food and Drug Administration (FDA) would be all about drug safety.[1] Indeed, that has turned out to be the case, even if some of the practical aspects thereof are yet to become clear. But before turning to that large subject area, let’s briefly survey what else has been going on. First, the money1. FDA started the year with funding of $US1.73 billion (about €1200 million or £950 million); this was a 9% increase over 2007 and, surprisingly, some $79 million more than the President requested. Of this huge amount, $682 million (39%) and $236 million (13.5%) went to the Centers for Drug and Biologics Evaluation and Research (CDER and CBER), respectively. The remaining 47.5% of the budget ($821 million) was for food regulation, and this adds to whatever the Department of Agriculture budget was this year. So, overall, it is certainly a Food and Drug Administration in that order. One empathizes with a Commissioner who is an oncologist and urological surgeon and is yet answerable to Congress for the hygiene of supermarket lettuce. Amongst the Critical Path Initiative priorities, at the beginning of the year the Agency identified clinical trial innovation, indication-specific initiatives and biomarker qualification. In February, arguably, these three areas synergized, leading to a remarkable drug approval. A supplemental license application for bevacizumab (Avastin®, Genentech)2, in combination with paclitaxel, was approved for first-line treatment of metastatic HER-2 negative breast cancer. Pivotal evidence of efficacy was solely on the basis of absence of disease progression; hitherto, survival studies had been the norm. Even more remarkably, this approval came after a 5–4 against verdict from the FDA’s Oncologic Drugs Advisory Committee. Genentech are required to conduct further studies, and the Agency always has the prerogative, at some later date, to change product labelling (including withdrawal of approv-
al for the indication). But this represents a true innovation in product approval in the USA.[2] Another clinical trial innovation came in April. From now on, no placebos are to be used in studies of patients with communityacquired pneumonia! Non-inferiority, active-controlled studies are now all right, and variability around a presumed 10% reduction in mortality due to active therapy may be used for their design. Have institutional review boards and ethics committees really been allowing placebo-treatment of pneumonia all these years? A busy time was had in the US courts this year over what is known as ‘pre-emption’. In a nutshell, there is capability for plaintiffs to sue drug and device manufacturers in both the Federal courts and those of the individual states. Some of the latter are viewed by plaintiffs as being more sympathetic to
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