Clinton proposes big budget for FDA

WASHINGTON - President Clinton acknowledged the heavy volume of work the Food and Drug Administration will shoulder in the years to come when he announced his budget proposal for fiscal year 2000. In total, the president earmarked $1.35 billion in funding for the agency - an amount 18% greener than the FDA's appropriations for 1999.

If enacted, Clinton's budget request will represent the largest addition to the agency's resources in history.

Included in that $1.35 billion is $195 million in proposed user fees, $145 million of which would be collected from the pharmaceutical industry under the Prescription Drug User Fee Act II. The remaining user fees would come from the food and medical devices industries.

The FDA has more than enough ways to spend the budgeted money, if it becomes a reality. Among many other tasks, the agency needs to implement the Food and Drug Administration Modernization Act of 1997, improve safety assurance for FDA-regulated products and hire more full-time employees in order to hasten the prescription drug review process.

Changing to a fully electronic, science-based adverse event reporting system (one goal of the FDA Modernization Act) would decrease the agency's bottom line by $15.3 million, the agency said. The system, which would boast uniform coding and nomenclature systems, would also employ more efficient, modern means of providing important feedback to the public and the health care community. The agency speculated that it would need to hire 11 additional full-time employees to complete the project.

To improve product safety assurance, the FDA would hire 155 full-time employees and increase the frequency of manufacturer inspections. In total, the agency said, the project would require $52.2 million in funding.

The FDA also indicated that it planned to spend a portion of the money on the President's initiative on food safety, youth tobacco prevention, bioterrorism and the construction of new laboratories. PR