Office of Management and Budget
Executive Office of the President
  Site Search     
 
About OMB  
- Organization Chart
- Contact OMB
 
President's Budget
- Budget Documents
- Supplementals, Budget Amendments, and Releases
Federal Management
- President's Management Agenda
- Office of Federal Financial
Management
-- Agency Audits
- Office of Federal Procurement
Policy
  -- CAS Board
-- FAIR Act Inventory
Office of Information and Regulatory Affairs
- OIRA Administrator
- Regulatory Matters
- Paperwork Requirements
- Statistical Programs & Standards
- Information Policy, IT & E-Gov
Communications & Media
- News Releases
- Speeches
Legislative Information
- Statements of Administration Policy (SAPs)
- Testimony
- Reports to Congress
Information for Agencies
- Circulars
- Memoranda
- Bulletins
- Pivacy Guidance
- Grants Management
- Reports
Site Map
First Gov  
eGov
|

September 24, 1997
(Senate)


S. 830 - FDA Modernization and Accountability Act of 1997
(Sen. Jeffords (R) VT)

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 are resolved.

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.