By Lisa Seachrist
WASHINGTON — Clinton Administration plans to compensate for an 8 percent cut in budget funds for the FDA with wide-ranging user fees appear unlikely to pass Congressional muster.
Members of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies took a skeptical view of the Clinton Administration's 1998 budget plan as presented by Michael Friedman, deputy commissioner for operations and soon-to-be acting commissioner for the agency.
Much of the discussion at the subcommittee hearing this week concerned the agency's handling of tobacco issues as well as the administration's tobacco prevention initiative and food safety initiative. However, Rep. James T. Walsh (D-N.Y.) raised the issue of the origin of the user fees with Friedman.
"Basically, we got Friedman on the record saying the idea for these fees came from the Office of Management and Budget," said Ron Anderson, a staff member in Walsh's office. "It was pretty clear that these fees provide no value to those paying them."
Currently, the FDA assesses user fees to the pharmaceutical and biotech industries in order to hire additional reviewers to speed the drug review process at the agency. The administration's budget calls for assessing additional fees to cover premarket and postmarket activity costs in the foods, human drugs, biologics, animal drugs and medical devices program areas. The money collected from user fees would then be used to cover the 8 percent cut in the agency's budget.
The Biotechnology Industry Organization has raised vehement objections to this plan. BIO's president Carl Feldbaum said, "Our number one objective is to stop the diversion of user fees away from their intended purpose."
Anderson noted that there "was no rationale for why the administration was assessing these additional user fees." He also stated that these user fees are "probably not going to happen. We are just going to have to find another way to restore the money to FDA." *