Reaping the Full Health Benefits of the Human Genome: The Duty to Warn and The Need to Establish a Comprehensive Federal Regulatory Structure for Genetic Testing

Abstract

This paper discusses the need for a comprehensive federal regulatory structure governing genetic testing. Particularly, the article proposes a legal standard to govern physicians’ duty to warn their patients about the implications that their genetic test results hold for relatives. The article advocates that this legal standard be tied to clinical guidelines developed by a national legislatively authorized commission. The author also suggests that a limited privilege exist for physicians or genetic counselors to warn family members directly when serious, imminent harm could be avoided thereby. The article also notes that such a legal standard is only justifiable if genetic tests’ safety and efficacy are assured by adequate regulatory oversight by the Food and Drug Administration (FDA) and other relevant federal agencies. The article concludes by discussing policy and legal arguments against greater FDA oversight of genetic testing and asserting that the FDA does have jurisdiction and should exercise it to regulate in-house genetic tests, – the so-called “home brews†– which constitute the majority of genetic tests provided.