The FDA has done an adequate job of preparing for novel technologies in the past. The FDA's experience in regulating products based on early biotechnology, artificial intelligence, and advanced biotechnology products demonstrate that the agency is able to acquire the scientific expertise necessary for effective regulation.
The FDA was able to equip itself for effective regulation of early biotechnology products. The biotechnology revolution was launched in 1976 when a human protein was expressed from recombinant DNA in E. coli. Recombinant DNA technologies resulted in products such as synthetic insulin to treat diabetes and interferon to treat leukemia, and the biotechnology industry began to take flight in the 1980s. The FDA responded to the emerging industry in several ways. First, the FDA decided not to create a new Center for biotechnology, but to incorporate biotechnology products into the current regulatory structure.70 Each product was regulated on a case-by-case basis for safety and efficacy. The Office of Biologics Research and Review (OBRR) became the FDA's "expert" in biotechnology review. OBRR hired specialists in molecular biology, protein chemistry, and immunology; almost all biotechnology products, including drugs and devices, were sent to OBRR
for review.71 The agency also began to draft documents called "Points to Consider" in the early 1980s.72 Although not regulations or guidelines, they were intended to facilitate dialogue and understanding between the FDA and the emerging industry. The FDA has continued to promulgate Points to Consider as the industry has advanced,73 and they are now considered "dogma in the field of biotechnology."74 Biotechnology advancements also led the agency to establish the Office of Biotechnology in 1990. The purpose of the Office was to "to enable [the] FDA to meet the new challenges presented by advances in the area of biotechnology."75 The Office advised the commissioner and other FDA officials on biotechnology science and policy, directed agency research and training, attempted to recruit and retain scientists with needed expertise, and represented the FDA on biotech matters to other agencies, industry, academia, and Congress.76 The establishment of the Office was lauded as effective in putting the FDA "at the forefront of recent advances in the industry."77 Having served its purpose of equipping the agency with the ability to effectively regulate biotechnology, the Office of Biotechnology was abolished in 1994.78
The FDA also took steps to enhance its science base in preparation for technology based on artificial intelligence. Scientists at CDRH began studying artificial intelligence and preparing for review long before they were presented with any applications. Neural networks, which use biological systems to process information, are now being used to create "smart" devices such as automatic Pap smear readers to do repetitive pattern recognition analysis. As one FDA official explains, "Our scientists saw that the use of artificial intelligence in medical devices was on the horizon and that we needed to have expertise in the area. As a result of our investment in this area, when the first application came in the door, we were ready for it."79
In the late 1990s and early 2000s, the FDA was faced with a wave of advanced biotechnology products. Breakthroughs in genomics, proteomics, gene therapy, and tissue engineering resulted in a significant increase in applications for clinical testing of novel technologies. In attempting to keep pace with the explosion of new technologies, the FDA has initiated four policies to improve the agency's effectiveness.
1. Former FDA Commissioner Jane Henney decreed several initiatives to improve the quality of the FDA workforce. She contracted with an outside group to work with the scientific staff and the office of human resources to determine the necessary composition of the scientific workforce in the near future.80 The contractor was also directed to investigate ways to improve recruitment and retention at the agency.
2. The FDA has made efforts to improve internal training. For example, the Centers put on monthly training sessions, the agency has established an alumni program to keep former staff involved in consulting and training efforts, and there have been efforts to cross-train staff through a scientific exchange program.81
3. The FDA has pursued an aggressive leveraging program involving collaboration with outside experts. There have been numerous "joint training" sessions with industry, where FDA staff tour manufacturing sites to learn about cutting edge research.82 There are also various Cooperative Research and Development Agreements (CRADAs) between the FDA and different companies,83 and CBER and CDRH have established "vendor days" to allow manufacturers to provide information about their products and research to FDA staff. The FDA has also pursued partnerships with universities84 and fostered its relationships with other public health service agencies,85 existing advisory panels and consultants, professional societies,86 and domestic and international standards organizations.87
4. The agency has taken steps to improve its regulatory science. Research activities allow the FDA to obtain independent laboratory information in reviewing applications, set standards for regulatory assessment, establish test methods, monitor products, and study emerging risks.88 The FDA highlights the success of its Tissue Proteomics Program as evidence of its ability to engage in cutting edge regulatory science.89 The research, which involves collaboration with the National Institutes of Health (NIH), focuses on developing proteomic tools for the early detection of cancer and other diseases.90 The FDA can also boast of cutting edge laboratory research in other areas.91
These reforms and initiatives have been relatively successful in enabling the FDA to regulate advanced biotechnology products. The agency has been able to spend some time developing a regulatory framework for genetic testing,92 tissue engineering,93gene therapy,94 and other novel technologies. Not only has the FDA worked diligently to establish regulations, notices, and guidelines regarding testing and manufacturing procedures, but there is evidence that it has been able to more efficiently review applications and better monitor clinical trials and manufacturing.95 As senior scientist Donald Marlowe explains, the "Centers can rely on their advisory panels and an array of outside experts to obtain expertise in any area."96
However, despite its best efforts to keep pace with advancing medical technologies, there is evidence to suggest that the FDA may begin to experience difficulties in maintaining expertise. In January 2004, a study from the Tufts Center for the Study of Drug Development warned that the FDA will face increased pressure to maintain staff expertise as experienced agency personnel retire or change jobs.97 Indeed, maintaining technical expertise in the coming years will be "a difficult task in the face of rapid technological change, staff turnover, and the broader context of high employment and movement of knowledge workers."98
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