Back to School: How biopharma can reboot drug development. Access exclusive analysis here

Raining on the parade

The biotech industry euphorically can point to last week's record-breaking funding haul - $1.8 billion - as a powerful sign of the recovery, indeed, resurgence of biotech. But the industry cannot ignore the spreading controversy over gene therapy, which almost certainly will bring calls to enlarge FDA's enforcement powers and raise public suspicions about the safety and ethics practiced by the entire medical research community.

The cooperative environment currently enjoyed by the industry and FDA was the product of years of careful and sometimes hard negotiations. The single quickest way to obliterate it is to put the agency on the defensive with Congress and the public about its ability to protect consumers.

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