Academic journal article Harvard Journal of Law & Technology

The Optimal Scope of FDA Regulation of Genetic Tests: Meeting Challenges and Keeping Promises

Academic journal article Harvard Journal of Law & Technology

The Optimal Scope of FDA Regulation of Genetic Tests: Meeting Challenges and Keeping Promises

Article excerpt

TABLE OF CONTENTS

I. INTRODUCTION
II. THE STATE OF THE ART
    A. Trends in Technology
    B. Current Oversight
III. SOURCES OF FDA JURISDICTION
    A. Devices
    B. Interstate Commerce
IV. THE PRACTICE OF MEDICINE LIMITATION
    A. The Example of Off-Label Prescribing
    B. A Guiding Principle for Genetic Test Regulation
V. CONCLUSION

I. INTRODUCTION

With the completion of the Human Genome Project and the advent of increasingly sophisticated genetic technologies, the promise that genetic advances will revolutionize medicine appears closer than ever. Soon, tests will function as medical crystal balls, forecasting risks of disease years into the future based on genetic variations. Medical care might soon benefit from tests that accurately predict the risk of common diseases with complex etiologies, such as cancers, Parkinson's disease, or Alzheimer's disease. (1)

Despite these hopes, fears have risen about the potential dangers of genetic testing. For instance, misleading and inaccurate tests can generate false diagnoses and lead to unnecessary treatment such as mastectomies for breast cancer patients. (2) Furthermore, without guarantees of privacy and confidentiality, both accurate and inaccurate genetic information might be used by employers (3) or insurers (4) to discriminate against patients. In response to some of these fears, many states have enacted legislation specifically to safeguard genetic information privacy (5) and to regulate the use of genetic information by health insurers. (6)

Given the risks associated with genetic testing, both the general public and the federal government have focused on perceived gaps in the regulatory oversight of genetic tests. (7) Most new genetic tests are developed and conducted in-house at a single clinical laboratory; these laboratory-developed tests are also known as "home brew" tests. (8) Tests may also be packaged as complete testing systems ("kits") and sold to multiple laboratories. (9) Although the Food and Drug Administration ("FDA") regulates kits, it does not regulate lab-developed tests. (10) This discrepancy drew the attention of federal oversight committees. (11) In recent months, the FDA has taken the first concrete step toward regulating lab-developed tests by issuing preliminary guidance for a subset of such tests known as In Vitro Diagnostic Multivariate Index Assays ("IVDMIAs"). (12)

Despite the FDA's initial efforts toward more sweeping regulation, questions remain about its legal authority and the proper boundaries of increased oversight. (13) This Note investigates the sources of the FDA's jurisdiction over lab-developed genetic tests and provides a guiding principle to ensure that expanded regulation does not nullify the benefits of genetic testing. Part II describes the trends in genetic tests and the current regulatory framework for such tests. Part III explores the constitutional and statutory sources of authority for FDA oversight of lab-developed genetic tests. Part IV argues that the FDA's long-standing policy against interfering with the "practice of medicine" should act as a limiting principle in the regulation of these tests. Part V suggests that such a principled approach will allow the FDA to ensure genetic test quality while avoiding the damaging effects of unbounded regulation on developing technologies.

II. THE STATE OF THE ART

A. Trends in Technology

Before exploring the proper scope of increased regulation, some understanding of the present state of genetic testing and the current regulatory framework may be helpful. Each person's DNA sequence is composed of billions of nucleotides, comprising a genetic code that programs the person's biological makeup. (14) Variations or mutations in the code affecting just a single nucleotide can correlate to a clinical outcome such as disease risk or drug response. (15) In their most basic form, genetic tests consist of two major steps: first, they identify key variations in a patient's DNA, and second, they correlate those variations to a clinical outcome to aid in medical care. …

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