Regulatory Beat: FDA Seeks Safer Drugs and Biologics - The agency is expanding systems to detect safety issues for blood, vaccines, and biotech therapies while examining the need for new approaches. -

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Regulatory Beat: FDA Seeks Safer Drugs and Biologics
The agency is expanding systems to detect safety issues for blood, vaccines, and biotech therapies while examining the need for new approaches.


BioPharm International
Volume 18, Issue 8

AVOIDING A SLOWDOWN

Manufacturers acknowledge that FDA requires more resources to ensure that the US has the world's safest drug supply. But industry is wary that excessive preapproval testing to detect rare safety problems, plus multiple postmarketing monitoring requirements, may block new products from coming to market. It is important to integrate drug safety information more effectively and to improve the assessment of true signals of potential safety problems, said Amit Sachdev, executive vice president of the Biotechnology Industry Organization to the IOM panel.

But Sachdev cautioned that creating post-approval regulatory processes that create uncertainty in the product approval process could delay patient access to innovative products. And he raised concerns that mandating any one "toolbox" for post-approval safety surveillance could waste valuable resources. One particular fear of manufacturers is that FDA may make raw AE data available to individuals who cannot assess it properly, potentially raising unnecessary alarms.

Instead, industry and FDA leaders believe a broader use of pharmacogenomics, biomarkers, and diagnostics may be more effective in enhancing the safe use of therapies. FDA acting Deputy Director Janet Woodcock advocates using genomic, proteomic, and metabolomic markers to identify those patients at high risk for certain side effects as part of a shift from today's empirical clinical research towards a more "personalized" approach for developing new therapies. Sachdev agrees that more active integration of health system data and pharmacogenomic information would be more effective than FDA's passive MedWatch system.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,


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