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N E W S F E At u r E
Fresh from the biologic pipeline
Randy Osborne reports on the latest product approvals.
2009 Nature America, Inc. All rights reserved.
Though still underfunded and low on staff, the US Food and Drug Administration (FDA) managed to approve 21 new molecular entities (NMEs) in 2008, picking up momentum in the second half of the year and breaking a slide in approvals that had continued since the turn of the present centuryexcept for the blip year 2004, when the agencys Center for Drug Evaluation and Research gave its blessing to 36 products. Included in 2008 approvals for NMEs were five new biologics (Fig. 1, Table 1), a slight uptick from 2007s 16 NMEs and two new biologics. In all, about 80 new drug applications and biologic license applications for medications won clearance in 2008, about the same as 2007, but most involved combo drugs, added dosing forms or new formulations of already approved compounds. The FDA is more focused on safety than ever, as Congress and the nervous public holds regulators and industry to harsh scrutiny.
Sara Radcliffe, vice president of science and regulatory affairs for Washington, DCs Biotechnology Industry Organization, cited no huge, unwelcome surprises in approvals. The Food and Drug Administration Amendments Act (FDAAA), signed into law in 2007, is still shaking out.
New rules
New this year is the Risk Evaluation and Mitigation Strategy (REMS) mechanism, made possible through the FDAAA, which is intended to deal with a known or potential serious hazard of a drug or biologic, taking the surveillance measures one step beyond post-marketing studies. Whether REMS will add steam to approvals, given the other pressures on the FDA, remains an open question.
The value of REMS will depend on the kinds of processes, tools and methodologies that are available for monitoring drug safety after marketing, and that is something that is very much evolving, Radcliffe says. Ways to carry out the routine, active monitoring and surveillance called for by FDAAA are still evolving too, as officials try to collate information from a wide selection of databases on drugs, patients and how they interact. A lot of work will have to be done to put in place a system that is what...