Premier Comments on Prescription Drug User Fee Bills

The U.S. House and Senate have passed separate versions of the Prescription Drug User Fee Amendments Act of 2012 and the bills now move to a joint conference committee to hash out a final version.

The Premier provider alliance has sent a letter of recommendations to conference committee leaders. The organization strongly supports a House provision to enable health care systems to repackage drugs in shortage and distribute them to affiliate hospitals. It also applauds both bills requiring implementation of a unique device identifier system, but asks for hard deadlines and firm requirements for implementation as soon as possible. Other suggestions:

* Adopt language that establishes a uniform national tracing network with traceability at the lot level and federal preemption of state pedigree laws; and

* Reconsider Senate language that changes the classification of specific doses and combinations of certain pain medication from Schedule III to Schedule II. “This would have the effect of requiring a new prescription, rather than a refill, for each dispensing,” Premier notes in its letter. “In turn, this change would create significant obstacles for patients who legitimately require this medication and be problematic for long-term care facilities, such as nursing homes, that may not have on-site physicians at their facilities on a full-time basis.”