Published Online: Monday, October 1, 2007

The nation's hospital pharmacists are urging Senate leaders to stand firm behind pending legislation that would give pharmacy practitioners influence in future FDA decisions to establish restricted drug distribution systems (RDDS) for certain new pharmaceuticals.

The agency places restrictions on distribution to manage risks associated with newly approved drugs. The American Society of Health-System Pharmacists (ASHP) is concerned, however, that in some cases RDDS may become burdensome for pharmacists.

At the request of ASHP, the Senate approved provisions in the new FDA user-fee bill designed to give pharmacists a say in the design of RDDS. Those provisions standardize RDDS and specifically mention pharmacists among the stakeholders that an FDA advisory group should consult for suggestions to make sure that programs do not pose a barrier to patient care.

Significantly, however, the House approved a separate FDA user-fee bill, and the differences between the 2 measures must be ironed out by a conference committee before a final version can be enacted.

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