FDA’s Proposed Guidance for Laboratory Developed Tests: How Should Regulators Balance the Risks and Promise of Innovation in Clinical Genetics?

I. INTRODUCTION

On September 30, 2014, the FDA released draft guidance for the regulation of laboratory-developed tests (LDTs), a previously unregulated class of in vitro diagnostic devices that includes most genetic tests. The new guidance, along with the FDA’s charged interactions with the direct-to-consumer genetic testing company 23 and Me, represent early regulatory attempts by the agency to gain a handle on genetic testing, which will continue to grow in frequency and significance for years to come.

The guidance has attracted much controversy, and stakeholders have been vocal in supporting and opposing the draft guidance. This article analyzes the soundness and significance of arguments for and against the LDT guidance, contending that the debate ultimately centers on a single underlying question: How should regulators balance the risks and promise of medical innovation in the rapidly-evolving area of genetics? The appropriateness of the FDA’s new draft guidance hinges on this question and we provide a clear framework for evaluating the practical and ethical factors at play now and in the future.

In the framework, factors such as the prevention of harm, the appropriate role of public health agencies, available alternatives, and the feasibility of the regulation are considered. Ultimately, in order to justify new regulation in the area of genetic testing, the government must demonstrate a state interest that outweighs the risks posed by increased oversight to innovation, investment, and access to genetic tests needed for clinical care in the era of personalized medicine.

II. BACKGROUND

In the past decade, the cost of sequencing a whole genome has dropped 2000-fold,¹ and the number of genetic tests available has risen to more than 24,000 tests for over 5,000 conditions.² The successful incorporation of these tests into clinical practice is the goal of personalized (alternately, precision) medicine, which is widely viewed as the future of the medical field.³ In fact, as Food and Drug Administration (FDA) Commissioner Margaret Hamburg noted in a 2013 blog post entitled “Personalized Medicine: The Future is Now,” the practice of personalized medicine has already begun.⁴ We are already using genetic testing to screen for and diagnose many diseases, contributing to our understanding of disease pathways and our ability to tailor treatments to the needs of individual patients.⁵

However, significant obstacles to the implementation of precision medicine remain. For instance, studies have indicated that most doctors lack the genetic literacy to be able to interpret and communicate the results of genetic tests.⁶ Furthermore, correctly establishing associations between diseases and gene variants continues to present a considerable challenge,⁷ and there is currently no standard method for assessing when a disease association has been sufficiently established, or clinically validated.⁸ Thus the pace at which genetic tests are being developed and utilized threatens to outstrip the capacity of healthcare professionals, medical societies, and regulators to verify their accuracy and guide their proper use in clinical care.

It is into this context that the FDA introduced its draft guidance for the regulation of LDTs,⁹ which include most genetic tests,¹⁰ on September 30, 2014. LDTs are ubiquitous in American healthcare; while some FDA-approved diagnostic test kits are commercially available, many clinical labs create and offer their own tests. Particularly in medical genetics, thousands of highly specific genetic tests have been developed as LDTs, either in the absence of a commercially available equivalent, or in order to avoid purchasing tests at the high prices set by commercial test manufacturers. According to the American Clinical Laboratory Association, over 11,000 labs are authorized to develop and utilize LDTs, and most of them do.¹¹

Predictably, the FDA draft guidance has precipitated strong responses from both proponents and opponents¹² who question the legal authority of the FDA, the necessity of the regulation, and the impact of the regulation on patients, laboratorians and medical professionals. While there is a growing literature on the benefits and challenges of regulating genetic testing,¹³ the literature is missing a clear method of balancing the policy considerations that arise. Before presenting the key issues and our proposed framework, we summarize the content of the draft guidance.

Outline of Draft Guidance for the Regulation of LDTs

The FDA defines an LDT as “an in vitro diagnostic (IVD) device that is intended for clinical use and designed, manufactured and used within a single laboratory.”¹⁴ According to the draft guidance, under the Medical Device Amendments (1976)¹⁵ of the Food, Drug, and Cosmetic Act (1938),¹⁶ the FDA has the authority to regulate the safety of IVDs. Since 1976, however, the FDA has exercised enforcement discretion for LDTs (i.e., chosen not to regulate) because they were traditionally simple tests (involving no high-tech instrumentation or software) that were used and interpreted within a single institution.¹⁷ Under enforcement discretion, thousands of LDTs, including most genetic tests, were developed and marketed without undergoing FDA review. In the draft guidance, the FDA notes that the nature and use of LDTs have changed, and thus so has its approach towards regulation. Laboratories are often commercial enterprises separated from healthcare delivery, and tests are now complex, offered in high volume, and play a greater role in “guiding critical clinical management decisions for high-risk diseases and conditions, particularly in the context of personalized medicine.”¹⁸

Currently, clinical laboratories are primarily overseen by the Centers for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). While details of the CLIA regulatory regime are beyond the scope of this paper, generally CLIA governs laboratory conditions, staff, and equipment.¹⁹ CLIA also requires that tests be analytically validated (verified for accuracy and precision) before any results are returned. Testing typically begins before verification of analytical validity, though, which occurs in a biennial survey.²⁰

With the new LDT guidance, the FDA aims to require not only more timely and robust verification of analytical validity, but also verification of clinical validity, which it defines as “the accuracy with which the test identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient.”²¹ In order to accomplish these goals, the FDA will require all labs producing LDTs to notify the FDA of the tests they are performing beginning six months after the guidance is finalized. The FDA will employ a risk-based, phased-in approach, meaning that initially (in the first five years), only high-risk tests will have to go undergo FDA review. Moderately risky tests will be phased in six-nine years in the future. According to the draft framework, the highest risk devices are those that are used to direct patient therapy, notably companion diagnostics (“devices that claim to enhance the use of a specific therapeutic product, through selection of therapy, patient population, or dose”), or those that have the same intended use as an FDA-approved device that has already been classified as high-risk.²²

The FDA will continue to exercise enforcement discretion (not regulate) for certain types of LDTs, such as traditional (simple) LDTs, LDTs for unmet needs (when no FDA-approved alternative exists), and LDTs for rare diseases (meaning there are no more than 4,000 total patients a year who would be subject to testing, since it would be difficult to verify clinical validity with such a small patient population). The guidance underwent a 120-day public comment period ending on February 2, 2015.

III. POLICY ISSUES IN DISPUTE

A. Necessity of New Regulation

The FDA has presented a consistent case for why it believes LDT regulation is now necessary and why its proposed guidance represents the proper course of action.²³ Regarding necessity, the FDA has cited several examples in which faulty testing has resulted in harm to patients. In a congressional hearing on the draft guidance, Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH), referred to instances in which ovarian cancer diagnoses and predictions of risk for heart disease were inadequately supported and data on the most suitable therapies for breast cancer were falsified.²⁴ It is unclear how often these kinds of events occur, however. The FDA acknowledges the dearth of data on the subject but contends that regulation will remedy this problem by ensuring that adverse effects of LDT use are reported and properly documented.²⁵ As Shuren stated, “Absence of evidence doesn’t mean there is an absence of a problem.”²⁶

Of course, the absence of evidence also does not indicate the presence of a problem, only that more evidence of harm must be collected before reaching sound conclusions. A mechanism for collecting data on harms caused by the misuse of LDTs (which is included in the draft guidance) could be implemented without beginning to regulate LDTs, so the need to amass more data is not sufficient reason to regulate. However, it may be difficult for the FDA to stand by and watch harms accrue for the purpose of data-collection. Our framework will help elucidate whether passively observing the accumulation of harms would be less desirable than regulating without sufficient data (which may or may not be the case here).

The FDA has also identified perceived gaps in the current regulatory system under CLIA. Most notably, the FDA is concerned that CLIA does not require labs to verify the clinical validity of LDTs. The question, then, is could CLIA perform this function? Some have argued that CMS does not have statutory authority, the will, or the resources to verify clinical validity under CLIA.²⁷ A CMS document delineating the different goals and methods of CLIA versus the FDA’s regulatory scheme²⁸ supports this view and the conclusion that the FDA system would complement rather than duplicate existing CLIA regulations.

Finally, another common objection to the draft guidance is that LDTs have contributed to significant medical successes in the past without regulation, so why regulate now?²⁹ The logic of this objection is flawed, however, since the past success of some LDTs is irrelevant to the question of whether and how LDTs should be regulated now. Surely LDTs have also contributed to past harms, and the fact that some LDTs have been extremely beneficial does not signify that all LDTs should continue to go unregulated.

B. Authority to Regulate

Many have questioned whether the FDA has the legal authority to regulate LDTs at all, or whether regulating LDTs should require congressional approval via an expansion of the agency’s legal authority.³⁰ Some have also objected to the FDA’s use of a guidance document instead of formal rulemaking procedures and assert that the FDA does not have the authority to regulate LDTs because the manufacture and use of these tests constitute a clinical service, or the practice of medicine.³¹ We take up these arguments below.

C. Feasibility of Proposed Guidance

The issue of whether the FDA has either the expertise or capacity to verify the clinical validity of many genetic tests, particularly given the large number of tests, has been raised. It does appear concerning from a regulatory perspective that there is no consensus on the appropriate standards for clinical validation of genetic tests. The FDA’s guidance framework proposes to use “clinical literature to support a demonstration of clinical validity,”³² but does not specify what level of clinical certainty is sufficient. Presumably, standards will need to be negotiated between clinical laboratories and the FDA, guided by the input of clinical geneticists and researchers who have studied the relevant tests. Regarding the feasibility of regulating such a large number of tests, the FDA has responded with a phased-in, risk-based approach, but it is difficult to assess whether the effort to pace implementation will be sufficient.

D. Impact on Innovation and Investment

Many critics are worried that LDT regulation will slow investment and hamper innovation in the burgeoning area of clinical genetics.³³ This is a common objection to government involvement in the marketplace, and the FDA’s regulatory process in particular.³⁴ It seems plausible that investors in clinical genetics will be discouraged by the new regulations, and that the regulatory process will slow the development of new tests and the updating of existing tests, thus bringing harm to patients in need of testing. However, these drawbacks could be outweighed by the possible need for regulation, and some have argued that verifiably accurate tests may result in greater investment long-term.³⁵

IV. RESEARCH AND RESPONSE

While the issues raised in the previous section will be addressed in depth below, it is worth noting that the central issue at stake is whether the benefits of the new regulations, should they come to fruition, outweigh the drawbacks, which are probable, at least to some degree. We have thus arrived at the familiar, fundamental question of how we should balance the need to guarantee the safety of novel medical technologies with the drive to develop new and better clinical tools. In the following section, we will outline a framework for approaching this question, focusing on the case of genetic testing. The framework will then be applied to the four issues of the current LDT debate raised above.

A. Framework for the Regulation of Genetic Testing

There is an extensive literature about regulation, particularly in the academic areas of law, political philosophy, and economics. While many analytic frameworks implicitly include the need to balance various interests and duties,³⁶ we make that view explicit and apply it to the context of genetic testing. In order for the government to justifiably regulate genetic testing despite the tradeoffs, it must demonstrate a state interest in regulation that outweighs the burdens of regulation.³⁷ In this section, we aim to analyze these factors, highlighting the features most relevant for evaluating the benefits and harms of FDA regulation, along with other considerations regarding the interests and duties of the relevant parties. In our framework, we outline the factors contributing to the state’s interest in regulation, and the countervailing interests that must be weighed in order for regulation to be justified.

1. State Interest in Regulating

Prevention of harm

The state must demonstrate that there is a harm that it is seeking to prevent or mitigate, and that the risk the harm will occur is significant with regards to a) magnitude and b) likelihood of occurrence. Taken alone, neither magnitude nor likelihood are sufficient for justifying regulation, since the potential death of a single person or slight discomfort of many thousands may not warrant state intervention. Regulators should ask: What negative health impacts may come about in the absence of regulation of genetic testing? Could health care resources go to waste? How many people may be affected how badly, and how much money might be lost? How likely is it that such harms will come about? Often, but not always, establishing potential for harm will involve demonstrating that harms of sufficient magnitude and frequency have occurred in the past, in the absence of regulation. Regardless of whether they are basing the need for regulation on a demonstration of past harm, regulators should explain the rationale behind their projections of future harm.

Absence of a superior alternate solution

Public health risks alone are not sufficient for establishing the necessity of new regulation; there must also be an absence of a superior alternate means (regulatory or otherwise) of preventing the specified harm that can be expected to take effect within a reasonable timeframe. If there is already an existing solution in place, regulators should consider the options of updating or improving the existing system, weighing the benefits of establishing a more effective system against the burden of designing and implementing a novel regulatory scheme.

Duty to regulate

The state must establish that it has been entrusted with the responsibility to prevent the specified harm. The foundation of the field of public health is that the government has a special responsibility for protecting and promoting the health of the people, which stems from the notion that in a democracy, the public has authorized the government to act for the common welfare.³⁸ It is not always clear, however, how far the state’s responsibility extends, and if the government has a duty to promote public health in a particular instance. For instance, the Supreme Court rejected the FDA’s efforts to regulate tobacco products in the case of FDA v. Brown & Williamson Tobacco Corporation and Congress subsequently passed a law specifically granting FDA jurisdiction over tobacco products. In the case of genetic testing, it must be demonstrated that the government, rather than medical professionals or professional societies, has the duty to prevent the specified harms from occurring. We should take into account that although “fiduciary duty” in the health context typically refers to a professional duty of a physician,³⁹ public health professionals may also have a kind of fiduciary duty to protect the public from harm, originating from the “moral trust society bestows on [public health] professionals to act for the common good.”⁴⁰

Feasibility

The state must demonstrate that it will be able to implement the regulations such that they can be reasonably expected to accomplish the intended goal (the prevention or mitigation of the specified harm). If regulation per se, or regulation given the available resources, is not possible, or is likely to be ineffective, the state interest will not be considered sufficient to outweigh the countervailing interests. Ineffective regulation will also be a waste of finite resources. In the context of genetic testing, the state must show that it has the capacity (e.g. expertise, resources) to effectively monitor, review and regulate genetic tests.

2. Countervailing Interests against Regulating

Harm to individuals and society

The state must consider the foreseeable harms, both direct and indirect, that may come to individuals, as well as to society at large, as a result of regulation of genetic testing. Regulation might limit access to tests, harming individual patients with restricted access to clinically useful tests needed to make informed clinical decisions. Furthermore, innovation in the area of clinical genetics may be slowed, resulting in diminished or delayed benefits to society more generally. Reduced investment in the field could have both short-term impacts on unemployment and long-term impacts on the health and welfare of the population.

Justice

Regulation might disproportionately affect some individuals or groups more than others, fostering or exacerbating inequality. For example, rural or minority communities that struggle with decreased access to novel medical technologies may be disproportionately impacted by a new regulatory framework for genetic testing. Similarly, businesses with fewer resources may be unable to overcome the hurdle of complying with regulation and could be pushed out of the market.

B. Application to Current LDT Debate

The framework presented above outlines the considerations that should be weighed when determining whether government regulation of genetic testing is justifiable. We will now examine whether the FDA’s proposed guidance for the regulation of LDTs meet the criteria for sufficiently weighty state interest in regulating genetic testing.

1. Necessity of New Regulation

The crux of the FDA’s argument for the necessity of increased LDT oversight is that regulations are needed to prevent harm to patients from faulty genetic tests. The FDA has enumerated several instances in which faulty LDTs have caused harm to patients, but it is unclear how grave past harms were, how often such events have occurred, and whether any progress in the development and use of genetic tests might undermine the projection that similar harms will likely come about in the future. Furthermore, nearly all examples of past harm given by the FDA have resulted from analytic inaccuracies or fraud, rather than errors in the clinical accuracy of genetic test results.⁴¹ In order to justify a new regulatory framework largely aimed at ensuring the clinical validity of LDTs, the FDA must demonstrate that serious harm is likely to result from errors in clinical accuracy. Otherwise, the existing CLIA guidelines on analytic validity, if better-enforced or slightly modified, may be sufficient for preventing harm to patients. If, however, lack of clinical validity is likely to cause harm to patients, CLIA would not be sufficient and the new LDT guidance would be necessary to prevent these harms.

2. Authority to Regulate

According to the FDA, the agency has had comprehensive authority to regulate in vitro diagnostic devices since the passage of the 1976 Medical Device Amendments, and LDTs are kinds of IVDs.⁴² While it has not yet chosen to regulate LDTs, the FDA argues that the fact that they previously exercised enforcement discretion does not indicate that they cannot begin to regulate LDTs now.

However, the FDA’s legal argument has been highly controversial. The American Clinical Laboratory Association recently hired Paul Clement and Laurence Tribe to challenge the FDA’s position. Clement and Tribe argue that LDTs are not diagnostic devices, but actually constitute the practice of medicine, which is not within the FDA’s jurisdiction.⁴³ Other legal scholars have similarly argued that the FDA’s proposed regulations upset “longstanding congressional and FDA policies on federalism that respect the primacy of States to regulate the practice of medicine.”⁴⁴ Tribe and Clement also assert that by using a guidance document, the FDA has “bypassed the notice and comment procedures” of the formal rulemaking process, in violation of the Administrative Procedure Act (APA).⁴⁵

While a comprehensive analysis of the legal argument is beyond the scope of this paper, we believe that the FDA’s authority would likely survive a challenge. The objection that the use of LDTs constitutes the practice of medicine appears ripe for dispute. While it is possible to view the interpretation of raw genetic data into clinically meaningful information as the practice of medicine, as this step is increasingly carried out by sophisticated interpretative software, the medical practice objection becomes more attenuated. Furthermore, if medical practitioners functionally rely on the software-generated results as they do other diagnostic tests, it seems reasonable that they should be regulated comparably.

Tribe and Clement raise a colorable claim that the FDA should have used notice and comment rulemaking under the APA rather than a guidance document to put forth a proposed system of regulation for LDTs. When notice and comment rulemaking is required to effect a policy change is the subject of ongoing debate among administrative and constitutional scholars.⁴⁶ Determining whether the use of a guidance document is acceptable in this case requires a careful review of the history of FDA’s assertion of regulatory authority over LDTs. Given the longstanding nature of the FDA’s position of enforcement discretion, we suspect that the FDA’s assertion of jurisdiction over LDTs would be upheld in court, but Clement and Tribe’s objection to the guidance method of regulation could carry some legal weight. Given the mounting political pressure and potential legal challenges, it is always possible that the FDA could elect to significantly modify the proposed guidance, or withdraw and reissue through notice and comment rulemaking. However, the agency may also feel constrained by the limited time remaining in the Obama Administration.

Beyond legal authority, one can also argue that the FDA has a moral duty to regulate LDTs in order to ensure their safety and efficacy. The FDA is charged with the task of “protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices.”⁴⁷ Under this broad mandate, it is reasonable to conclude that the FDA actually has a moral duty to regulate LDTs. This duty is not only derived from the laws defining the FDA’s regulatory role, but also from the corresponding trust and expectations of doctors and patients. If physicians rely on the results of genetic tests as they do other tests that have been analytically and clinically validated by the FDA, the FDA may have a duty to ensure the analytic and clinical validity of genetic tests as well. Especially given the lack of genetic literacy on the part of many physicians, a duty may exist between the FDA public health officials and the doctors and patients utilizing genetic tests.

3. Feasibility of Proposed Guidance

The feasibility of the FDA’s proposed framework could pose a significant obstacle to regulation, though the FDA has taken important steps to reduce its immediate regulatory burden. The phased-in, risk-based approach, with continued use of enforcement discretion in a number of cases, should alleviate feasibility concerns relating to the agency’s limited resources. Some believe that the FDA’s approach is still unrealistic, however, given the rapid rate at which new and improved genetic tests are being developed. Another concern about the feasibility of the regulations is whether the FDA will be able to verify clinical validity, given that establishing the clinical validity of many genetic tests remains an active area of scientific research. What standards will the FDA use to determine if a test is clinically valid, and will a large proportion of tests fall under the “unmet needs” and “rare disease” exceptions until an adequate literature is available? If so, perhaps the FDA will not have an influx of tests to regulate, but the opposite. More information regarding the capacity, aims, and means of regulation is needed before determining whether it will be feasible to implement and enforce the proposed guidance.

4. Impact on Innovation and Investment

The concern about the regulations’ impact on innovation and investment stems from the fear that regulations will decrease access to genetic tests and impede patient care. While this fear is understandable, additional information is necessary to determine how likely it is that this harmful result will come about. We do not have a sense of what level of societal harm might be caused by the proposed regulations with respect to jobs lost, businesses closed and overall investment slowed in the area of clinical genetics. Nevertheless, it seems plausible that patients will have delayed or restricted access to some genetic tests, which could cause harm if inadequate diagnoses lead to suboptimal treatment decisions. The unmet needs and rare disease exceptions are designed to ensure that access to tests is not limited by the new regulations, but if FDA-approved tests are only offered in some healthcare settings or insurance companies restrict coverage to FDA-approved tests, patient access to genetic tests may nonetheless be reduced. Regarding justice considerations, some have argued that the proposal will disproportionately harm small laboratories, which will be unable to compete with large companies with ample resources for preparing and submitting tests for FDA approval. Furthermore, it is possible that if access to LDTs is limited, it would disproportionately affect certain populations, particularly those who already have limited access to the latest medical technologies in rural or poorer urban settings.

V. IMPACT OF POLICY RECOMMENDATIONS

In light of this framework, more information is needed to determine whether the FDA’s LDT guidance stands on firm ground. Specifically, additional information regarding the nature of past harms caused by faulty LDTs (insofar as the FDA has this information), the economic impact of the proposed regulations, and the effects the regulations will likely have on access to clinically useful tests is required. The economic impact of any new FDA policy should be assessed, though conducting such an analysis is particularly important for the regulation of genetic testing, since the field of clinical genomics is in its early stages and may be particularly vulnerable to the economic repercussions of increased oversight. Though the FDA is responsible for supplying the information needed to justify regulation, opponents should also provide more detailed accounts of potential regulatory harms including reduced access to tests and slowed investment and innovation.

In addition, the FDA should inform and cooperate with professional societies’ efforts to educate doctors on the clinical application of genetics. If the safety and efficacy of genetic tests is the FDA’s goal, the agency should support initiatives to improve genetic literacy among medical professionals by making it clear where its role in ensuring patient safety ends and clinicians’ role begins. Verification of the clinical validity of genetic tests does not obviate the need for clinicians to be able to understand and communicate the results of genetic tests well.

Furthermore, the FDA should work, with others, to develop a clear set of standards for determining clinical validity. How many experiments, with how many subjects, with what level of statistical significance are sufficient? Without such standards, it will be difficult for the FDA to establish clinical validity in a reliable and consistent manner. The agency is currently exploring the possibility of using the NIH’s ClinVar database to establish clinical validity via comparison with a large number of samples and held a public workshop on the regulation of next generation sequencing tests on February 20, 2015.⁴⁸ However, the FDA needs clinical validity standards before it pushes ahead with the LDT oversight. Alternatively, it can postpone regulation until professional guidelines establishing clinical validity are available.

Finally, once the regulations are in place, the FDA should monitor access to genetic tests in order to ensure that patients are not excessively harmed and that subsets of patients and businesses are not unduly burdened. This will ensure that the possible harms caused by additional oversight are justly distributed and proportional to the nature of the problem.

VI. CONCLUSION

If the FDA clearly addresses the issues raised in the framework presented here, it will be in a position to make a strong case for the regulation of genetic testing in general, and for the proposed LDT guidance in particular. While the rapid advancement of clinical genetics might pose a particular challenge to regulation in this area, it does not altogether preclude the possibility of responsive, scientifically-legitimate regulation. Although the proposed guidance has generated much controversy in the genetics community, ultimately we all share a common goal: safe and accurate genetic tests that can be used effectively and efficiently to further the aims of personalized medicine.

POLICY RECOMMENDATIONS.

FDA should:

• Produce a comprehensive summary of known past harms caused by faulty LDTs

• Conduct an analysis of the economic impact of the proposed regulations on innovation and investment in the area of clinical genetics

• Develop a clear set of standards for determining clinical validity

• Support initiatives to improve genetic literacy among medical professionals

• Monitor access to genetic tests in order to ensure that patients are not excessively harmed as a result of the new regulations

Biographies

Michelle Bayefsky is a pre-doctoral fellow in the Department of Bioethics of the National Institutes of Health (NIH), where her work focuses on issues related to the regulation of genetic testing, the ethical challenges posed by innovations in genetic technology, and questions that arise at the intersection of genetics and reproductive medicine. She has served as an intern at the Senate HELP Committee and UNESCO’s Bioethics Programme, and a researcher at Yale’s Interdisciplinary Center for Bioethics. She graduated summa cum laude from Yale University in 2014 with a BA in Ethics, Politics and Economics.

Benjamin Berkman is a faculty member in the NIH Department of Bioethics where he is the head of the section on the ethics of genetics and emerging technologies. He has a joint appointment in the National Human Genome Research Institute. He received a BA in the History of Science and Medicine at Harvard University (1999). He subsequently earned a JD and an MPH from the University of Michigan (2005). Mr. Berkman’s research interests span a wide range of topics. His current work focuses on the legal and ethical issues associated with genomic research and emerging technologies.