September 24, 1997
The Administration applauds the Senate for its bipartisan effort to improve S.
830 since it was reported by the Senate Committee on Labor and Human Resources,
and appreciates the Senate's responsiveness to concerns that have been
raised. Because of the importance of obtaining a five-year extension of the
Prescription Drug User Fee Act (PDUFA), the Administration has no objection to
passage of the bill by the Senate at this time. However, the Administration
finds that the provisions identified below are unacceptable and as the
legislative process continues, will work to ensure that our remaining concerns
In general, this legislation represents a significant step toward accomplishing our mutual goal of assuring the agency's optimum performance while protecting the health of the American public. The Administration, however, continues to have two major concerns with the bill.
First, section 404 of the bill would lower the review standard for marketing approval by precluding the Food and Drug Administration (FDA) from reviewing new medical devices for uses other than those for which the manufacturer says they are intended. Second, the PDUFA trigger as proposed in S. 830 undercuts the bipartisan budget agreement (BBA) by requiring budget increases for FDA not envisioned by the BBA, and would interfere with HHS' ability to allocate resources appropriately throughout the Department.
In order to be able to support the final bill, the Administration will continue to work with the House of Representatives and in conference to resolve these and other identified issues.