Freedom of Information:

FDA's Program and Regulations Need Improvement

HRD-92-2: Published: Oct 11, 1991. Publicly Released: Nov 14, 1991.

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

GAO found that: (1) two FDA regulations were inconsistent with FOIA, and other such regulations did not accurately reflect the current state of the law, even though they had been superseded by Department of Health and Human Services (HHS) regulations that did; (2) the FDA practice of precluding immediate appeals of minor deletions of information from documents and requiring the requester to make a second request for the deleted information is unauthorized by FOIA, but FDA believes that this practice benefits requesters by giving them releasable information more quickly; (3) the FDA policy of releasing trade secrets unless the submitter intervenes in a lawsuit seeking their release is inconsistent with laws expressly prohibiting the unauthorized release of such information by FDA; (4) FDA regulations did not incorporate changes made by FOIA amendments or an executive order regarding processing fees and predisclosure notifications; (5) although FDA has generally complied with predisclosure notification requirements, it may not be recovering all the FOIA costs to which it is entitled under the law; and (6) although the law did not set a time limit for providing information to a requester, in about 45 percent of the reviewed cases, FDA did not meet its 10-day notification requirement, but usually provided the information within 30 days.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: Regulations were published on January 5, 1994.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

 

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