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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (7833)	2/6/2003 12:49:59 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Telling drug companies about potential problems earlier in the review cycle would certainly make a fundamental difference to the industry: FDA's new head vows to speed product review By Christopher Bowe in New York Published: February 5 2003 20:31 \| Last Updated: February 5 2003 20:31 The chief US medicines regulator is taking his new initiatives to Wall Street, reassuring healthcare executives that a top priority of the Food and Drug Administration (FDA) is to speed and streamline the product review process. "This is a healthcare year. Healthcare costs and product innovation are extremely important issues," said Mark McClellan, FDA commissioner, at a UBS Warburg health service conference on this week. Dr McClellan had a similar message at a Merrill Lynch conference. Foremost among Washington's concerns is the need to speed and improve the development and approval of new genetic and traditional drugs, medical devices and veterinary products. Drugs companies and their Wall Street backers hope FDA will help them bring their products to the market sooner and more cheaply. A plan unveiled by FDA last week outlined a scheme intended to remove confusion between regulators and medical companies that sometimes leads to delays and higher development costs. The move could mark a surge in FDA activity, which many pharmaceutical industry leaders have anticipated since Dr McClellan's appointment late last year. FDA's plan places emphasis on communication, better review efficiency and clear outlines for new technologies to treat diseases. The agency, which oversees products accounting for one-fifth of US consumer spending, had been leaderless for nearly two years after the election of President George W. Bush. Industry leaders had grown increasingly concerned that the FDA lacked direction on some key regulatory issues, and feared delays over new drug approvals. An FDA product-review performance report last year - which gave the agency a passing grade overall but "mixed results" in new product reviews - sparked recommendations to improve medi cal technology in the future. But longer approval times for new drugs and medical devices concerned the FDA. "These results call for decisive action now, so that the trends of the future are not toward fewer products with higher development costs," Dr McClellan said . Last year, the FDA approved 17 new drugs (not genetically derived), down from 24 in 2001 and significantly below the 53 approved in 1996. Average approval time last year for priority drugs rose to 16.3 months from six months the year before, even as review times decreased for non-priority drugs. Under the new plan, the FDA's first goal is to reduce costly product development delays by informing companies of regulatory issues and approval targets earli er in the process. This could help avoid repeat cycles in the review. news.ft.com