EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON, D.C. 20503
STATEMENT OF ADMINISTRATION POLICY
(THIS STATEMENT HAS BEEN COORDINATED BY OMB WITH THE CONCERNED AGENCIES.)
October 7, 1997
H.R. 1411 - FDA Regulatory Modernization Act of 1997
(Rep. Burr (R) NC and 16 cosponsors)
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:
In order to be able to support a final bill, the Administration will continue to work in conference to resolve these and other issues, including (1) the lack of user fees for food contact substances, (2) the effective restriction on public comment on regulations issued under the Nutrition Labeling and Education Reform Act, and (3) the imbalance between the regulatory and resource requirements in H.R. 1411 and in S. 830, the Senate companion bill.
- The PDUFA funding mechanism 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.
- The third-party review for medical devices provision is too broad. It makes almost all Class II devices eligible for third-party review and requires FDA to include all eligible devices in the third-party review pilot. By contrast, the Senate bill would establish a pilot that would include only 60 percent of eligible devices and gives FDA authority to exempt any device that is of substantial importance in preventing the impairment of human health.
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.