Drug safety bill delayed

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Bicameral staff negotiations that were expected to propel a Food and Drug Administration overhaul to conference have stalled, and several key lawmakers have given up on clearing a compromise before recess.
Both the House and Senate have passed legislation (HR 2900, S 1082) to overhaul the FDA’s drug safety and approval functions and reauthorize its user fee program, which underwrites reviews of new drugapplications.

The House bill contains several far-reaching drug safety provisions, while the Senate has pushed for including language to allow FDA approval of generic versions of biotech drugs.

Thursday morning, Sen. Michael B. Enzi, R-Wyo., objected to a unanimous consent request by Majority Leader Harry Reid, D-Nev., to call up HR 2900, substitute the Senate text, pass the bill and request a conference with the House.
In a statement, Enzi said negotiations between House and Senate staff had broken down and that House Democrats had sacrificed completion of work on the FDA bill to advance a measure (HR 3162) to expand the State Children’s Health Insurance Program, which passed Wednesday night.

Enzi’s objection was an about-face from a week earlier, when he had written to Reid requesting that he move ahead.

“Had I known that this was what the House Democrats wanted a few days before, I would not have hand-delivered that letter to the Majority Leader and the Minority Leader,” Enzi said in Thursday’s statement, referring to Democrats’ plan to delay.

An Enzi spokesman said the stalemate is over an insistence by Rep. Henry A. Waxman, D-Calif., that the final bill include House language on a database of new drug clinical trials.