FDAnews Drug Daily Bulletin


Feb. 9, 2006

The Senate committee that oversees the FDA hasn't decided whether it will support the agency's proposed industry user fee for reinspections of manufacturing facilities, questioning what it sees as a "unique" approach to increasing FDA funding.

The agency submitted a legislative proposal to institute the new industry user fee to the Senate Health, Education, Labor and Pensions (HELP) Committee as part of the Bush administration's recent budget proposal. The fee would fund the FDA's reinspections of manufacturing plants that fail initial review.

The HELP committee is reviewing the proposal, focusing on the fact the proposed $22 million fee would be the first of its kind, a spokesman said.

"The reinspection user fee proposed in the president's budget is unique," said HELP committee spokesman Ryan Taylor. "Existing user fee programs within FDA do not have a requirement for additional fees for products or establishments that do not pass initial review. With that in mind, the committee is actively reviewing the proposal to determine whether to move it forward."

The committee wants the agency to provide information to ensure that such a fee is applied in a consistent and predictable manner, said another Senate aide familiar with the issue. As part of HELP's oversight role, it wants to know how this money would be spent, the source said.

The FDA will be asked to explain how it determines the cost of reinspection. For example, reinspections can take place both domestically and at foreign facilities. Would the cost of travel expenses be included in the fees?, the source asked.

Because there is no other fee that applies after a company fails an initial review, "there is no model to compare this to," the source said. The committee wants all information necessary to determine if the new fee represents an "undue burden," the source added.

The fee would fund the inspections the FDA takes to verify a firm's corrective actions following good manufacturing practices violations. Agency procedures usually require the agency conduct a follow-up inspection of the firm within 90 days of issuing a warning letter.

The agency would allocate $12.3 million from the new fee for 102 field inspectors, $7.1 million for indirect and support costs, including legal costs and science review, as well as $2.6 million for rent and rent related costs, the budget states. "Revenue from the user fee would reimburse FDA for costs associated with the 118 [full time employees] and related expenses" to reinspect firms that failed to comply with agency regulations, the budget adds. Approximately 1,270 reinspections are expected in fiscal 2007.