Originally Published MDDI April 2002
The genomics revolution requires collaboration
Charles Fort, iconoclast and collector of oddities, observed that when the time comes to build steam engines, steam engines will be built. Once the process starts, nothing can stop it. The same is true of medical technology. Despite all the forces that may sometimes seem arrayed against medical progress, that progress continues.
The real concern, for industry and society alike, is not that technology will not advance, but that we will not be prepared when it does so. If we are to reap the benefits of these inevitable advances, manufacturers and regulators alike must be more creative in balancing innovation with the needs of society.
A dramatic example of this reality can be found in the in vitro diagnostics (IVD) sector of industry, the subject of this month's special supplement. Sparked by the completion of the human genome project, along with advances in miniaturization and information processing, IVDs stand on the brink of a revolution that promises to transform healthcare, and society along with it.
The potential benefits of these molecular diagnostic products are enormous. Already they are speeding the development of new, highly targeted pharmaceuticals. Soon they may also lead to a fundamental change in the practice of medicine, from the traditional approach of diagnosis and treatment to a one of prediction and prevention of disease. But is society ready for such change? How will it deal, for instance, with the complex issues of privacy and ethics in diagnosing an individual's susceptibility to a disease for which there is no cure?
Similarly, how will regulators handle these highly complex products? FDA is keenly aware of the potential of molecular diagnostics, but these new technologies are likely to challenge FDA in several ways.
Given the shortage of expertise in these technologies, it would seem advisable for one center within FDA to have responsibility for all IVD products. But to judge from the response to pending legislation, HR 3580, that would shift the responsibility for regulation of IVD products from CBER to CDRH, there is no consensus for such a change. The proposal, not surprisingly, has raised turf issues between the centers as well as between IVD manufacturers and the blood industry.
Molecular diagnostic products will also test the agency's re-engineered and reformed systems. In an article for Cambridge Health Institute, Joseph Hackett, MD, associate director for clinical laboratory devices at FDA, said, "If you come to us with, for example, a test that has less than 50 analytes, we can handle that. But if you are using thousands of analytes (typical in a microarray), we really do not know what to do in terms of regulatory approval. We have time frames set up based on the old paradigm of device approval, but how can we meet these time frames for high-information-content diagnostics?"
Hackett urges industry to be involved in devising draft guidances and standards that will ultimately help FDA review these products more effectively and in a timely manner.
Despite posing new challenges and ethical issues, the genomics revolution is underway. The agency's internal politics will be unavoidable but need not impede the introduction of new products. The active participation of manufacturers will be critical for creating a new regulatory strategy. It will be equally important for industry and regulators to address societal issues.
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