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

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Regulation of the biologics marketplace can take many different forms and must be equipped to pivot quickly to address countless threats to public health. For example, Congress appropriated $300,000 for FDA to hire 48 temporary investigators to help prevent the diversion of DBS-cleared lots of licensed Salk polio vaccine from legitimate distribution channels—those used by the six producers to ship vaccine to the states and then to public and private distributors. FDA provided the training, oversight, and on-site assistance for the temporary staff. Though unclear how long this program would last, the agency did not encounter any missing vaccine. A case from 2003 illustrated another turn the regulation of biologics could take. FDA’s Office of Criminal Investigations, established only shortly before, announced the discovery of counterfeit Procrit (epoiten alfa) in the marketplace. Some samples were contaminated with bacteria, and FDA laboratories found others completely lacking in active ingredient. Both the manufacturer and FDA alerted healthcare providers and patients as well to the problem and the lot numbers in question. Four months later Criminal Investigations announced three convictions in this case, though it was unclear if patients had been injured by the counterfeit product.

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Manufacturer Warning (Ortho Biotech Products) Noting Box Printing Flaw of Counterfeit Procrit.

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Manufacturer Warning (Ortho Biotech Products) Noting Lot Numbering Flaw of Counterfeit Procrit.

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

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