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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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.

GAO found that: (1) the FDA database of information on review boards and laboratories was adequate and complete for use in scheduling inspections; (2) FDA increased its database maintenance staff and changed its regulations for easier investigator identification to eliminate a 9-month backlog and make the database more reliable; and (3) FDA revised its policy manual to assign joint responsibility for selecting studies for review to the drug review divisions and DSI. GAO also found that: (1) DSI conducted over 400 for-cause investigations of clinical investigators over the past 10 years usually due to indications of wrongdoing, unusually large numbers of investigations, or the importance of a study to a new drug application; (2) although DSI participation was necessary to maintain staff knowledge of particular drugs and improve interaction with drug review divisions, its participation had little effect on inspection results; (3) FDA completed only 88 of the 190 reviews scheduled within 12 months of receipt of NDA and did not notify its district offices of the need to make reviews until at least 1 year after receipt on almost 73 percent of the remainder; and (4) district involvement in other high priority work, such as product-tampering investigations, delayed timely completion of reviews.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: In November 1988, FDA issued instructions to district offices providing criteria for abbreviated reports of inspections of sponsor contractor research organizations.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: FDA issued final procedures on June 11, 1988, which provide for selecting clinical studies and reporting results of NDA reviews in a timely manner.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: The FDA/CDER original NDA supplement action package checklist was modified in June 1988 to incorporate this recommendation.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

 

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