October 7, 1997
The Administration applauds the House for its efforts to produce a bipartisan
FDA reform bill, and appreciates the 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
House passage of
H.R. 1411 at this time.
This legislation represents a significant step toward accomplishing the mutual goal of assuring the Food and Drug Administration's (FDA) optimum performance while protecting the health of the American public. The Administration, however, continues to have major concerns with the bill and will work to ensure that these concerns are addressed. For example:
According to CBO estimates, H.R. 1411 would be subject to the pay-as-you-go requirement of the Omnibus Budget Reconciliation Act of 1990 because the bill's provision extending market exclusivity for certain drugs would increase direct spending. CBO estimates that H.R. 1411 would increase direct spending by $65 million during FYs 1999-2002. OMB's preliminary scoring of H.R. 1411 is under development.