Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

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A significant change in oversight of blood came with the finalization of new good manufacturing practices for all blood banks, transfusion centers, and blood processing entities. Among other provisions, these required testing all donations for hepatitis, standards were established for tests given to patients prior to the administration of blood or a blood product, any fatality involving a blood donation or administration had to be reported to FDA immediately and required recordkeeping for blood products was extended. A retrospective analysis of plasma derivatives submitted since 1960 up to 1973 indicated that almost all lots of plasma protein fractions had the Hepatitis B Antigen.

In 1975, FDA issued a regulation requiring that all blood, plasma, or serum used for biological products must be tested by the latest, “third generation,” technology. This included reverse passive hemoagglutination and radioimmunoassay, which were 10 to 100 times more sensitive than the most common test required since 1972, counterelectrophoresis. Results from FDA’s contractual partner in evaluating the latest testing procedures, the New Jersey Department of Health, indicated that the new testing technologies would identify and thus eliminate from consideration as many as two times as many units of hepatitis-contaminated blood.

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FDA Inspector Mildred Woodward, at left, reviews processing records with a blood bank lab supervisor (from the FDA Consumer June 1973).

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Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV) was licensed by FDA in 1990. Since an immune-suppressed organ recipient may be unable to fight off the effects of the virus, this action would help to protect kidney transplant patients from the effects of cytomegalovirus that may have been transmitted through the organ of CMV-positive donors.

In July 1986 FDA licensed the first therapeutic monoclonal antibody, Muromonab CD-3, to treat acute rejection of transplanted kidneys. The biologic bound to the T cell CD-3 antigen and rapidly dispatched the T lymphocytes.

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Monoclonal Antibody Production (from CBER’s publication, From a Rich History to a Challenging Future (2002).

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In 1990, CBER approved the use of live bacteria to treat bladder cancer. BCG Live (after bacillus Calmette-Guérin), a freeze-dried suspension, was delivered directly to the bladder via a catheter to treat pathogenic cells lining the inner surface of the organ—and thus a treatment designed for earlier stages of the illness. The patient retained the product for two hours before voiding, and the treatment would be repeated for the next several weeks or months.

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Preliminary Bureau of Biologics testing of BCG Live Intravesical to treat bladder cancer.

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CBER and the National Cancer Institute (NCI) began a collaborative research and clinical project in 2001, the Clinical Proteomics Program, to make a comprehensive study of all proteins in living cells and apply this to the clinical care of cancer patients. Drs. Emanuel Petricoin in CBER and Lance Liotta of NCI led the effort, which was funded for three years about $1 million annually. The two groups had already developed new or improved analytical technology for the purpose, have identified more than 130 different proteins found in several types of cancer. Using the latest microscopic procedures to biopsy cells pre- and post-treatment would allow the team to analyze the impact of different therapies on tumor protein patterns. Among other benefits the Program hoped to achieve was earlier ability to diagnose cancer, a better sense of toxic and beneficial effects from the lab before clinical application, and improved understanding of tumors at the protein level, and better treatments for cancer patients. The following year the Proteomics collaborative reported preliminary results in The Lancet on diagnostic developments they uncovered by using protein patterns found in normal serum and that collected from an ovarian cancer patient.

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Dr. Lance A. Liotta, at right, and Dr. Emanuel F. Petricoin, at left.

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The 2007 Food and Drug Administration Amendments Act gave the agency authority to require a manufacturer to submit and carry out a Risk Evaluation Mitigation Strategy (REMS) for selected biologics or drugs to ensure a product’s benefits outweigh its risks as a condition of the product’s approval. FDA issued its first guidance under this authority in 2009. The elements of a REMS included a variety of communication devices to help inform the patient about using the therapy, such as medication guides and patient package inserts; a communication plan for the healthcare provider; and other elements to ensure safe use of the product aimed at the prescriber, dispenser, and the patient. The draft guidance addressed the format and content of the REMS, its assessment, and a timetable for submitting it.

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Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

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