Consuming Genomics: Regulating Direct-to-consumer Genetic and Genomic Information

• Publication year: 2021

92 Nebraska L. Rev. 677. Consuming Genomics: Regulating Direct-to-Consumer Genetic and Genomic Information

Consuming Genomics: Regulating Direct-to-Consumer Genetic and Genomic Information

Kayte Spector-Bagdady, J.D., M. Bioethics and Elizabeth Pike, J.D., LL.M.(fn*)

TABLE OF CONTENTS

I. Introduction .......................................... 678

II. Access to One's Own Genetic Information .............. 684
A. The Human Genome .............................. 684
B. Origins and Evolution of Genetic Testing .......... 686
1. From Discrete Genetic Tests to Large-Scale Testing and Genomic Sequencing .............. 687
2. From Clinician-Provided Testing to Direct-to-Consumer Access .............................. 689
C. Concerns Raised by Direct-to-Consumer Genetic Testing ........................................... 690
1. Investigation by the Government Accountability Office in 2006 ................................. 692
2. Reports of the Secretary's Advisory Committee on Genetics, Health, and Society ............... 693
3. Investigation by the Government Accountability Office in 2010 ................................. 696

III. Regulating Direct-to-Consumer Genetic Testing ........ 697
A. Food and Drug Administration: Regulation of Medical Devices and Engagement with the Direct-to-Consumer Genetic-Testing Industry ............. 698

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1. Food and Drug Administration's Regulation of Medical Devices ............................... 699
2. Exemptions for Genetic Tests Under In Vitro Diagnostic Device Regulations ................. 702
3. FDA Sends Notification Letters to Direct-to-Consumer Genetic-Testing Companies .......... 704
a. Food and Drug Administration Untitled Letters .................................... 705
b. Food and Drug Administration Warning Letter to 23andMe ......................... 710
c. What the Food and Drug Administration Letters Mean for the Industry .............. 713
B. Federal Trade Commission: Regulation of Advertising and Engagement with the Direct-to-Consumer Genetic-Testing Industry ................ 717
C. Centers for Medicare and Medicaid Services and the Clinical Laboratory Improvement Amendments . . . . 719
D. Patent and Trademark Office and the Association for Molecular Pathology v. Myriad Genetics, Inc. . . . 722
E. State Law's Regulation of Direct-to-Consumer Genetic Testing ................................... 726

IV. Regulating Bifurcated Direct-to-Consumer Genetic-Testing Entities ....................................... 728
A. The Bifurcation of Direct-to-Consumer Genetic-Testing Entities ................................... 728
B. Regulating Entities Producing Genetic Data ....... 730
C. The Challenges of Regulating Entities That Provide Genetic Information ............................... 731
1. Regulating DTC Web-Based Genetic Interpretation Services: In Search of an Analogy ....................................... 732
a. WebMD's Symptom Checker ............... 732
b. Mobile Medical Devices .................... 734
c. Software Applications ...................... 735
2. First Amendment Challenges to Regulation . . . . 735

V. Risk-Based Regulation of Entities That Interpret Genetic Information ................................... 742

VI. Conclusions and Implications .......................... 743

I. INTRODUCTION

In 2007, two direct-to-consumer (DTC) genetic-testing companies began offering consumers an interpretation of 0.03% of their genome

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for $1000.(fn1) In the years since, the popularity of, and scientific know-how behind, genetic testing has exploded.(fn2) The healthcare industry has spent an estimated $5 billion on genetic testing to date, with $20 billion more expected by 2021.(fn3) President Barack Obama's Presidential Commission for the Study of Bioethical Issues recently released one report focusing on privacy and progress in whole genome (genomic) sequencing(fn4) and another considering the ethical issues facing the direct-to-consumer industry;(fn5) coverage about the influence of genetic testing on celebrity medical decisions has reverberated throughout the lay media;(fn6) the recent Supreme Court decision of Association for Molecular Pathology v. Myriad Genetics established the nonpatentability of genetic material;(fn7) and a U.S. Food and Drug Administration (FDA) warning sent to 23andMe on November 22, 2013,(fn8) and the company's

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subsequent hiatus from the health-related information market,(fn9) have critically shaped scholarly debate about the science and ethics of, and reinforced the public's interest in access to, health-related genetic information.(fn10) Despite this increasing visibility, DTC genetic testing has met with controversy and complications throughout its short history.

The medical testing of human genetic material began with discrete genetic tests that looked at a single gene to obtain an answer to a targeted question about a potentially devastating medical condition-such as whether a person was at a high risk to develop Huntington's disease.(fn11) It has since transitioned to large-scale genetic testing or genomic sequencing, returning information about many or all of a person's genes, including those for which the function and significance is still unclear.(fn12) During this time, both targeted and large-scale testing moved from being within the exclusive province of the clinic-where healthcare professionals were the gatekeepers of this information-to DTC entities that provide genetic data and interpreted information directly to consumers without a clinician intermediary.

Over the past several years, the DTC genetic-testing industry has been the subject of a number of government investigations, including one in 2006 by the U.S. Government Accountability Office (GAO); two reports by the Secretary's Advisory Committee on Genetics, Health, and Society in 2008 and 2010; and a subsequent GAO investigation in 2010. These reports raised serious concerns about the validity and utility of the genetic testing performed by the companies and the medical information that DTC companies were producing and selling to consumers.

Despite these investigations, the DTC genetic-testing industry flourished until 2010, when Pathway Genomics announced that it was going to partner with Walgreens and sell its DTC genetic tests in drug stores across the country.(fn13) This garnered the attention of FDA,

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which responded by sending twenty-three letters warning companies of potential Food, Drug, and Cosmetic Act violations and stating that DTC genetic tests were medical devices that needed to be cleared or approved by FDA.(fn14) Soon thereafter, many DTC genetic-testing companies either altered their models by requiring a physician order or intermediary or collapsed entirely. 23andMe also began to work with FDA on clearance filings in 2012,(fn15) but in 2013 FDA halted 23andMe's health-related offerings indefinitely.(fn16)

Even before 23andMe stopped marketing its health-related product, however, some DTC companies began to bifurcate into entities that offer genetic data-a file of As, Ts, Cs, and Gs without any interpretation-and entities that interpret and analyze this genetic data to provide medical information-for example the consumer's risk of developing breast cancer.(fn17)

While these bifurcated companies might still be unfamiliar to the public, their influence has played a role, for example, in the well-known case of Henrietta Lacks. The 2010 book The Immortal Life of Henrietta Lacks tells the story of a woman who went to the Johns Hopkins Hospital in 1951 for clinical care for her cervical cancer. Unbeknownst to Mrs. Lacks, her clinicians retained specimens of her cancerous tissue for research purposes.(fn18) The unique and invaluable replicating propensities of her cancer cells enabled the creation of the

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first human cell line, and this "HeLa" line was subsequently distributed across the world, enabling countless research protocols and rendering Mrs. Lacks "the godmother of virology and then biotech, benefiting practically anyone who's ever taken a pill stronger than aspirin."(fn19) The HeLa cells did not, however, benefit Mrs. Lacks's own family any more than any other. The Lacks family did not even know Mrs. Lacks's cells had been taken in the first place. While this part of the Henrietta Lacks story has become popularized, in 2013 researchers at the European Molecular Biology Laboratory sequenced the HeLa cells and publically posted the genomic sequence of Mrs. Lacks's cancer cells without consent from the Lacks family. This raw data file of As, Ts, Cs, and Gs did not convey medical information in and of itself; the European Molecular Biology Laboratory stated in a news release that "We cannot infer anything about Henrietta Lacks's genome, or of her descendants, from the data generated in this study."(fn20) However, the emergence of new DTC web-based genetic interpretation entities transforms the value of raw genomic data-other scientists were immediately able to upload Mrs. Lacks's genomic data into openSNP, a service that interpreted the data and provided access to her medical information.(fn21)

With 23andMe's health-related product currently off the market, bifurcated genetic entities are not only the next frontier, but the only currently viable option for DTC access to genetic health-related information. This Article is one of the first to analyze the effect of the 23andMe...