FDA 224-57-3004 2. Nothing in this agreement will preclude DSA repre- 3. FDA personnel carrying out inspection services will V. VI. Page 3 This agreement, when accepted by both parties, will have an effective date beginning July 1, 1974, and continue for an indefinite period of time, and may be modified by mutual consent of both parties or may be terminated by either party upon a thirty (30) day advance written notice to the other. COST DSA shall reimburse FDA an amount not to exceed $20,000 for FY 75 services as outlined in this agreement. FUND ING A. Billing will be based on the rates effective under the Food and 224-75-3001 B. FDA shall submit vouchers quarterly, on Standard Form 1080, Defense Personnel Support Center Philadelphia, Pennsylvania 19101 Attn: Medical Materiel Directorate C. Administrative billing requirements shall be in accordance VII. AUTHORITY Page 4 This agreement is entered into under the authority of the Economy Act approved June 30, 1932, as amended 31 USC 686. Mr. MCKENZIE. During and subsequent to a series of meetings involving foreign inspection, we exchanged information with the FDA concerning our quality assurance program for drugs and other medical materiel. On May 24, 1974, we instructed the Defense Supply Agency and the Defense Medical Materiel Board to initiate negotiations with the FDA to make maximum utilization of the resources and facilities of the FDA. A copy of this letter is provided for the record. [Testimony resumes at page 11776. The information referred to follows:] SUBJECT: Quality Assurance System for Centralized Drug Procurement (b) OMB Study Report entitled "Interagency Group Report Referenced documents contain a recommendation that the quality "The department is committed to cooperate with the FDA It is requested that action commence in conjunction with FDA and the For these deliberations the following guidance is provided: Any action proposed under the new system must be procurement process and insure contractor compliance o It is understood that the current methodology employed • DoD will continue to develop item characteristics and The Good Manufacturing Practice (GMP) regulations Recommendations for changes in DoD policy to include Additional implementing instructions regarding this matter are expected in the near future from the Office of Management and Budget (OMB). Additional guidance, as appropriate, to include a firm date for the submission of your plan will be provided at that time. It is not envisioned that the plan will be required earlier than one hundred and twenty (120) days from this date. Lt. Colonel T. D. Wood (telephone 695-4938) is the point of contact on this matter. cc: ASD(Comptroller) ASD(I&L) Chief, DMMB Commissioner, 7DA 54-476 0 - 75 - 10 Vernon McKenzie Acting Assistant Secretary Mr. MCKENZIE. The DSA organized a DOD task group to conduct negotiations with the FDA. This task group met for the first time on June 11, 1974, with appropriate DOD agencies participating. Representatives of my office participated as observers in the task group deliberations. On June 4, 1974, OMB issued guidance on the procurement and distribution of medical supplies and nonperishable subsistence and tasked the Secretary of HEW with the responsibility of developing a quality assurance plan for medical materiel. A briefing for FDA representatives was presented by DOD on June 13, 1974. This briefing provided officials of FDA with an analysis of our quality assurance program for drugs. It provided information concerning our requirements for drugs, their specification development and use, and the relationship of our quality assurance procedures to the DOD drug procurement program. It also highlighted our preaward survey procedures for prospective contractors, our quality assurance program as it affects contract administration, and the quality assurance of drug supplies in government storage. As a result of this briefing, FDA representatives requested that they be afforded an opportunity to visit a representative Defense Contract Administration Services Region and some selected drug firms to witness the DOD quality assurance program in practice. During the week of July 14, 1974, a visit was made to our New York office and three pharmaceutical firms whose DOD contracts are administered by the New York office. This provided FDA with further insights into DOD purchasing procedures, related contract administration and quality assurance. On August 6, 1974, the Commissioner and senior officials of FDA met with me and selected senior officials of Defense agencies to discuss the quality assurance subject. On September 19, 1974, the FDA conducted a briefing and discussion for senior officials involved in Federal contracting. Again, as Dr. Lee has indicated, five interagency task groups were organized on September 24, 1974, to review all aspects of Federal purchasing of drugs and to make appropriate recommendations that would offer a government-wide quality assurance program plan for drugs. These were Task Group 1. Specifications, chaired by DOD; Task Group 2, Standards, Good Manufacturing Practices and related material, chaired by FDA; Task Group 3, Pre-award Surveys and On-Site Inspections, chaired by FDA; Task Group 4, Product Testing, chaired by DOD; and Task Group 5, Certification Lists, chaired by FDA. A sixth task group on nondrug items was recognized but not established at this time. However, on April 2, 1975, this task group was activated under the chairmanship of DOD. The completion of the implementation plan being developed by this last group is expected by September 1, 1975. The interagency groups were requested to cover the assigned areas in considerable depth and to complete their task by the 15th of January. Each group was required to describe the quality assurance systems now in existence and to include the manpower and other resources required to operate these systems. Each group was also charged with the responsibility to design or describe a conceptual system as it would operate under the FDA's direction and to include |