Genetic Testing and FDA Regulation: Overregulation Threatens the Emergence of Genomic Medicine

The January 2015 edition of the Journal of the American Medical Association addresses a November 2014 announcement by the US Food and Drug Administration (FDA) of its intention to regulate thousands of medical diagnostic tests being performed in as many as 11,000 clinical laboratories throughout the United States, focusing especially on genomic medicine. Although the FDA is well intentioned, the current plan for regulation is unnecessary and, if carried out, could result in the closure of many laboratories, undermine innovation, and potentially limit patient choice. Moreover, the proposed regulation, if unchanged, is likely to lead to thousands of laboratory submissions to the FDA, for which its own staffing capacity is tenuous at best. If implemented, the requirements may have the unintended effect of derailing the long-awaited emergence of genomic medicine.

The proposed actions of the FDA could have important negative consequences. As the American Medical Association has stated in its formal comment on the FDA’s plans, “The FDA proposal adds an additional layer of regulatory requirements which may result in patients losing access to timely life-saving diagnostic services and hinder advancements in the practice of medicine.” Academic laboratories, from which much of the innovation in genetic testing derives, have insufficient resources to meet the proposed requirements of the FDA and would essentially be precluded from developing (or even improving) tests in response to patient needs, clinician demands, and changing technology. All that remain may be a few very large laboratories and commercial manufacturers who have the resources necessary to meet the new FDA requirements on each test they perform and pay the inevitable user fees associated with FDA oversight. Such a situation would be particularly difficult for patients with rare genetic diseases, for whom laboratory-developed tests are the only testing option because of insufficient financial incentives to sustain a commercial market.

Too much regulation can be as harmful as too little. A nuanced middle ground must be found that protects the public and allows for innovation. Patients and the public are just beginning to benefit from the long-awaited genomic revolution in medicine. Overly zealous regulation should not impede progress by those who are best prepared to develop the next generation of genetic tests and deliver on the promise of genomic medicine.

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