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FDA Actions, Economy Affect Biotech Industry

Increased scrutiny by federal drug regulators and continued mergers and acquisitions activity could curb expansion in biotechnology and pharmaceutical industries, according to analysts and economists. A capacity constraint caused by a shortage of manufacturing facilities also could chill the overheated biotech market and job growth as companies exhaust their three-year funding cycles in the next few years, cautions Robert Toth, portfolio manager of the medical technology fund of EGM Capital in S

Peg Brickley
Increased scrutiny by federal drug regulators and continued mergers and acquisitions activity could curb expansion in biotechnology and pharmaceutical industries, according to analysts and economists. A capacity constraint caused by a shortage of manufacturing facilities also could chill the overheated biotech market and job growth as companies exhaust their three-year funding cycles in the next few years, cautions Robert Toth, portfolio manager of the medical technology fund of EGM Capital in San Francisco. The Food and Drug Administration approval of treatments tarries because of organizational problems and because of a renewed safety focus.

"There is no FDA commissioner, no champion for the agency right now," Toth says. "For the first time in four years, in 2000 the FDA spent a long time in reviewing and approving new drugs. It was a pretty dramatic slippage. Biotechs, in particular, depend on rapid drug approvals from the FDA, because they do not...

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