Freedom of Information: FDA's Program and Regulations Need Improvement

Highlights

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) implementation of the Freedom of Information Act (FOIA).

Recommendations

Recommendations for Executive Action

Agency Affected	Recommendation	Status
Department of Health and Human Services	To strengthen FDA administration of its FOIA program, the Secretary of Health and Human Services should direct FDA to rescind its FOIA regulations concerning minor deletions and private-party interventions.	Closed – Not Implemented HHS concludes that the minor deletions regulation does not interfere with the public's access to FDA information and that any change will add significant costs to HHS FOIA programs. Also, HHS believes that the third-party intervention regulation has been highly effective in practice and allows FDA to operate in the most efficient and cost-effective way.
Department of Health and Human Services	To strengthen FDA administration of its FOIA program, the Secretary of Health and Human Services should direct FDA to update its regulations regarding fees and predisclosure notifications to reflect the requirements of the law and executive order.	Closed – Implemented Regulations were published on January 5, 1994.
Department of Health and Human Services	To strengthen FDA administration of its FOIA program, the Secretary of Health and Human Services should direct FDA to better account for costs related to its FOIA activities so that FDA has greater assurance it is recovering through its fee charges all allowable costs.	Closed – Implemented FDA awarded a contract to determine if current FOIA billing techniques were assessing the full costs that current law and regulations allowed FDA to collect for responding to FOIA requests, to recommend cost-effective improvements in FDA billing practices, to compare billing allowed by current regulations with what the law allows, and to recommend any appropriate changes. The contract work produced was not usable because of inaccurate data. A proposal for additional funds to correct the inadequacies was rejected. FDA trained of all personnel that process FOIA requests to ensure that the maximum allowable fees were being collected.
Department of Health and Human Services	To strengthen FDA administration of its FOIA program, the Secretary of Health and Human Services should direct FDA to take measures that would better ensure that it complies with the statutory 10-day notification requirement.	Closed – Not Implemented HHS believes that FDA is doing an excellent job of complying with the statutory requirement for responding to FOIA requests. FDA attributes delays to several factors. A contributing factor to the delays is the heavy workload FDA has to accomplish with few employees. HHS feels that to make significant improvement over its already excellent record, FDA would require additional staff and funds.

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Topics

Information Management

Federal legislationFeesFreedom of informationProprietary dataHealth carePublic officialsLitigationRural economic developmentNational securityGovernment information