FDA's Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies
HRD-88-100
Published: Sep 12, 1988. Publicly Released: Oct 12, 1988.
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Highlights
In response to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) Division of Scientific Investigations' (DSI) activities, specifically: (1) its responsibilities relating to the approval of new drug and biological products; (2) the accuracy of FDA data and adequacy of oversight of clinical investigators, review boards, and laboratories involved in studies supporting new drug applications (NDA); and (3) the adequacy and timeliness of for-cause inspections.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Health and Human Services | To enable FDA to carry out its bioresearch monitoring responsibilities in a more timely manner, the Secretary of Health and Human Services should require the Commissioner, FDA, to finalize procedures in the staff manual guide for selecting clinical studies for review and include provisions for communicating the results to officials responsible for reviewing new drug applications. |
FDA issued final procedures on June 11, 1988, which provide for selecting clinical studies and reporting results of NDA reviews in a timely manner.
|
| Department of Health and Human Services | To enable FDA to carry out its bioresearch monitoring responsibilities in a more timely manner, the Secretary of Health and Human Services should require the Commissioner, FDA, to give DSI direct access to the FDA automated management information system on incoming NDA to facilitate inspection scheduling. |
FDA purchased and installed a computer system on January 18, 1989, and completed a cable hookup with DSI in June 1989 to provide it with NDA data. DSI personnel completed training on March 1, 1990.
|
| Department of Health and Human Services | To enable FDA to carry out its bioresearch monitoring responsibilities in a more timely manner, the Secretary of Health and Human Services should require the Commissioner, FDA, to establish goals or time frames for scheduling and completion of inspections prior to the approval of NDA. |
Beginning July 14, 1988, FDA established goals and the need for inspections after FDA reviews NDA. Sponsors will be required to submit all reports and supporting data prior to completion of inspection by FDA.
|
| Department of Health and Human Services | To enable FDA to carry out its bioresearch monitoring responsibilities in a more timely manner, the Secretary of Health and Human Services should require the Commissioner, FDA, to change the current quarterly assignment system so that clinical investigator inspections are assigned to district offices in a more timely manner. |
Beginning August 1988, FDA issued assignments immediately rather than quarterly to affected district offices and concurrent notification was made to the Office of Regulatory Affairs.
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| Department of Health and Human Services | To enable FDA to carry out its bioresearch monitoring responsibilities in a more timely manner, the Secretary of Health and Human Services should require the Commissioner, FDA, to allow district offices to write abbreviated inspection reports when inspectees are in substantial compliance with FDA requirements. |
In November 1988, FDA issued instructions to district offices providing criteria for abbreviated reports of inspections of sponsor contractor research organizations.
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| Department of Health and Human Services | To enable FDA to carry out its bioresearch monitoring responsibilities in a more timely manner, the Secretary of Health and Human Services should require the Commissioner, FDA, to require that a statement concerning the results of DSI inspections be included in all new drug application approval packages and that inspection classification letters be included in the NDA file. |
The FDA/CDER original NDA supplement action package checklist was modified in June 1988 to incorporate this recommendation.
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