Political wrangling ties up PDUFA vote; Inside the off-label compromise


WASHINGTON - Senate Labor and Human Resources staff, White House officials, and senior FDA and Department of Health and Human Services officials worked into the night several days last week in an effort to get S. 830, the Food & Drug Administration Modernization & Accountability Act, onto the Senate floor. They didn't manage to pull off the trick, although they thought they were close a few times.

BIO President Carl Feldbaum likened the frustrating behind-the-scenes machinations to prank birthday candles. "Every time you think you've blown them out, they light up again," he said.

The difficulties in moving S. 830 to the Senate floor illustrate the reasons why

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