12.1 The Growing Relationship Between Pharmaceutical and Medical Device Manufacturers and Drug Courts

United States’ pharmaceutical companies and medical device manufacturers are marketing their products directly to drug courts – with controversial results.Footnote ¹ These activities can be associated with court policies and staff beliefs that are anti-agonist – opposed to forms of medications for opioid use disorder (MOUDFootnote ²) containing opioids. Anti-agonist beliefs and policies can harm client outcomes when judges narrow MOUD options to one medication, or partner with providers who prefer one medication.

In the Greenwood City, Indiana, drug court overseen by Judge Lewis Gregory, patients received a neurostimulation medical device called the Bridge to assist them with detoxification before transitioning to Vivitrol. Judge Gregory began using the device in February 2017 after meeting with the manufacturer, Innovative Health Solutions (IHS). His court also only used Vivitrol because he “was certainly not going to do a medication-assisted treatment program with drugs which people used to get high.”Footnote ³ But IHS did not receive FDA marketing authorization until November 2017, and existing research used controversial methodology and lacked IRB oversight.Footnote ⁴ Were such concerns raised with the decision makers? Perhaps not, given that these decisions were occurring in a court rather than in a clinical setting. In the Hocking County Municipal Vivitrol Drug Court near Athens, Ohio, Judge Fred Moses decided to only allow clients to access the non-agonist medication Vivitrol – a choice he made after meeting Vivitrol’s manufacturer, Alkermes, at a professional conference and asking sales representatives to send the court’s affiliated clinician free starter doses.Footnote ⁵ This decision ran counter to medical standards and professional guidance supporting client access to all types of MOUD.Footnote ⁶

Manufacturer relationships with criminal justice institutions and drug courts represent a new frontier. Alkermes sales representatives have marketed Vivitrol to court officials in numerous states, including Missouri, Massachusetts, Ohio, West Virginia, Alaska, and Indiana, and administered injections to parolees in Michigan, Illinois, Wisconsin, Vermont, New Hampshire, and Pennsylvania; it has also lobbied state and national policy makers for laws favoring Vivitrol.Footnote ⁷ As of 2017, Vivitrol was used in 450 publicly funded initiatives, such as court and parole programs, in 39 states.Footnote ⁸ While manufacturer-court relationships are relatively novel, their conventional counterpart, the pharmaceutical sales representative-physician marketing efforts, has generated a robust body of scholarship that is helpful in understanding their potential consequences.

One might assume that effective gatekeepers keep watch over these relationships and their consequences, including the FDA, federal and state legislatures, state court systems, and/or legal and medical professional associations that at least ensure that public officials receive accurate and complete information about MOUD. But these gatekeepers are nonexistent, lack important knowledge, or are susceptible to manufacturer influence. Meanwhile, these industries are attempting – and succeeding – at persuading local communities and states to use limited or less-effective MOUD options.

This chapter examines the growing relationships between medical device and pharmaceutical manufacturers and drug courts, arguing attention must be paid to reveal and interrogate potentially detrimental influences that can harm client outcomes. Section 12.2 describes the manufacturer-drug court relationship, explores treatment team beliefs about MOUD, and explores two examples. Section 12.3 applies a conflict-of-interest framework to assess these relationships and discusses how treatment teams can be “moral entrepreneurs” that make non-evidence-based choices against clients’ best interests. Section 12.4 poses potential solutions to this dilemma.

12.2 The Relationship Between Drug Courts and Medical Manufacturers

States have created drug courts as a therapeutic alternative to incarceration in cases involving nonviolent, low-level criminal charges.Footnote ⁹ Instead of incarceration, drug court clients can live and work in the community if they follow drug court requirements, including treatment policies. Studies suggest that, on balance, drug court program participation is more effective than incarceration at preventing drug use relapse and reincarceration.Footnote ¹⁰ The Trump Opioid Crisis Commission commended drug courts as a “central component of the pretrial diversion process,”Footnote ¹¹ encouraging their implementation in all ninety-three Federal district courts and every US county.Footnote ¹²

12.3 Moral Entrepreneurship and Conflict of Interest

To understand the potential for bias and conflicts of interest in selecting treatment providers and the associated forms of treatment made available to drug court program enrollees, it is helpful to examine these issues in a related context: the industry sales representative-physician relationship. Some experts believe conflicts arise because business and medical ethics differ: businesses, including medical device and pharmaceutical companies, commonly reward vendors to stimulate sales, while such conduct could be problematic or unethical in medicine.Footnote ⁵⁴ The most controversial practices are industry sponsorship of continuing medical education programs (CME) and “detailing,” where industry sales representatives (ISRs) “visit physician offices to discuss the availability and suitability of products.”Footnote ⁵⁵

Advocates of close industry-physician relationships describe them as “a full, honest, fair, and balanced discussion of materials” that gives providers “invaluable assistance” in selecting appropriate medications, and providers reciprocate by giving drugs “preferred status on a hospital’s formulary.”Footnote ⁵⁶ Because physicians cannot keep up with extensive literature and innovations, the ISR visit is an “extremely effective” encounter, providing essential information in five or ten minutes.Footnote ⁵⁷ Thus, pro-industry advocates assert, marketing communications sell products and facilitate “technology transfer.”Footnote ⁵⁸ The potential for bias here is clear; but industry advocates argue that “[a]lthough information coming from a commercial source does present the product in the best possible light, physicians are well aware of this bias and correct for it.”Footnote ⁵⁹ Moreover, they contend, visits from competing ISRs “expose[] physicians to multiple biases,” allowing them to “make a more informed choice.”Footnote ⁶⁰ They concede, however, that physicians make prescription decisions by “relating the decision to a personal value system” to which ISRs can appeal.Footnote ⁶¹

A 2019 study found that pharmaceutical manufacturers alone spent more than $20 billion marketing to health care professionals in 2016, including $5.6 billion for prescriber detailing.Footnote ⁶² This study also acknowledged their statistics significantly underestimated the amount industry spent on professional marketing, as the authors were unable to acquire data on marketing related to devices, meetings, and events. While independent firms produce CME programs, they have been found to “skew training material in favor of commercial interests” to retain business.Footnote ⁶³

Critics of close industry-physician relationships describe a conflict between product promotion and education and assert that patients’ interests are not best served by industry-influenced prescribing practices.Footnote ⁶⁴ Although physicians often believe they are not influenced by marketing, research clearly shows otherwise.Footnote ⁶⁵ These sophisticated promotional activities exploit the professional’s vulnerabilities, often at subconscious levels, to create biasesFootnote ⁶⁶ and influence prescribing habits in ways that may not best serve the care recipient.

12.4 Identifying a Range of Potential Solutions

Much can be done to avoid improper influences that may occur in relationships between pharmaceutical manufacturers and drug courts and defuse any potential resulting conflicts. These solutions range from “light” to “heavy.” In practice, widespread changes in approaches to court-industry relationships may occur gradually.

An effective “light” solution would be to systematically affirm that a judge’s role is overseeing court proceedings as “captain of the ship” and monitoring clients. This role does not, however, include making treatment decisions. Decisions like whether MOUD is appropriate for individual clients, and in which form, must be left to a treatment provider.Footnote ⁸² Judges’ comments that they will not allow forms of MOUD that can be diverted or with opioid ingredients reflect inappropriate encroachment on the treatment provider’s role. Physicians should receive complementary educational messaging through professional medical associations such as the AMA. Drug courts should also be encouraged to include local physicians on treatment teams or as consultants. Logically, the ideal medical professional would be a practitioner offering holistic treatment options to whom the drug court judge refers clients seeking MOUD. This may be difficult in several areas of the country, however, based on qualified providers’ availability and willingness to serve, although new telehealth and expanded methadone rules may extend access to more distant providers. Additionally, since court staff select the health care providers with whom programs partner, they may opt into relationships with providers who have anti-MOUD attitudes.

Another solution would be to provide judges and staff with alternative educational resources free from industry sponsorship. It is not suggested that judges and staff intentionally invited industry representatives to influence court proceedings in earlier years. Rather, courts’ eagerness for informational resources were an educational vacuum that pharmaceutical and medical device manufacturers were prepared to fill. Alternative educational content can be provided online and at professional conferences and are currently coordinated through professional associations such as NADCP and NCSC. Some governmental and non-profit organizations have begun offering MOUD-focused education tailored to judges, including information about the appropriate MOUD decision-making role of court team members.Footnote ⁸³

A more involved solution would be to attach restrictions and requirements to court funding, such as conditioning grant monies on court compliance with best practices of allowing all three kinds of MOUD. Recipients of federal Bureau of Justice Assistance (BJA) grants, for example, have to demonstrate that they will not deny clients access to their programs because of MOUD use.Footnote ⁸⁴ This would provide some federal regulatory oversight enforcing best practices; however, this solution has limited reach as only approximately 200 out of 3,000 drug courts nationwide receive BJA funds. State grants could incorporate similar conditions.

A still more comprehensive solution would be to impose state-level certifications mandating that drug courts adhere to certain standards, such as permitting all three forms of MOUD, agreeing to refer clients to certain licensed facilities that must accept Medicaid, etc. For example, Michigan’s certification programFootnote ⁸⁵ requires courts to comply with several standards and best practices, including the BJA’s Key ComponentsFootnote ⁸⁶ and the National Center for DWI Courts’ Ten Guiding Principles of DWI Courts.Footnote ⁸⁷ These guidelines require drug courts to allow MOUD use “when appropriate, based on a case-specific determination and handle MOUD very similarly to other kinds of treatment” and assert that “the court does not determine the type, dosage, and duration of” MOUD.Footnote ⁸⁸ Similarly, states can pass statutes or regulations prohibiting MOUD bans within courts, as has already occurred in some states.Footnote ⁸⁹

Finally, a model sunshine law for drug courts could be an integral component of an effective solution scheme. Federal court and employee rules require financial disclosures for gifts and reimbursements above a certain threshold.Footnote ⁹⁰ Federal laws such as the Physician Payments Sunshine Act, passed in 2010, make financial relationships between medical industrial corporations and physicians more transparent and reveal COIs, requiring pharmaceutical, medical device, biological and medical supply manufacturers who are covered by Medicare, Medicaid and the State Children’s Health Insurance Program to track financial relationships with teaching hospitals and physicians and report that data to the Centers for Medicare and Medicaid Services. A mandatory disclosure approach acknowledges the role of those seeking to influence system development (the manufacturers) as well as the system participants. A model state sunshine law could encourage states to re-evaluate decisions made years ago, particularly court policies or referral practices prioritizing Vivitrol over agonist treatments.

A sunshine law by itself, however, will have little impact. Disclosure plays a paramount role in avoiding liability for COI but it alone is not a viable solution. If disclosures are made after antecedent acts produce relationships that enable improper influences, the harm has already occurred. An efficacious intervention should take place before acts can lead to partiality.Footnote ⁹¹ Disclosure alone does not eliminate problematic relationships, thwart influence, or prevent partial behavior.Footnote ⁹² Disclosure of judicial beliefs regarding MOUD would do little but expose easy marks for manufacturers to exploit. Thus, sequestration – prohibition of most industry engagement with drug court team members – may be more effective than disclosure, because eliminating problematic relationships eliminates COIs.Footnote ⁹³ Full sequestration need not be imposed due to First Amendment concerns. Instead, state courts administrators could prohibit court team members from meeting with industry representatives, or accepting free lunches or other items from manufacturers.Footnote ⁹⁴ Additionally, state professional licensing boards (e.g., bar associations) could forbid licensees from applying manufacturer-provided training toward required continuing legal education credits.

Of course, the most effective strategy would be to deploy a web involving many of these proposals. Here, policy makers can follow Alkermes’ example, implementing a comprehensive array of educational opportunities and regulatory and oversight measures at local, state, and national levels, in partnership with diverse professional organizations representing law, medicine, and the court system.

The current debate over medical device regulation pits safety against innovation. Those in favor of greater regulation point to the need to protect patients from the harms of insufficiently tested devices. Those in favor of less regulation cite the need to promote innovation and move potentially lifesaving devices to market faster.Footnote ¹ At present, the less regulation, more innovation camp is winning the debate – in part on the argument that postmarket surveillance systems can adequately address safety concerns. But framing the debate this way leaves out key inputs: efficacy and relative effectiveness.

Not all innovation is created equal nor is it equally desirable. The best innovation creates medical devices that are superior to current alternatives, either because they lead to better patient outcomes or because outcomes are just as good, but the care is cheaper. The ideal innovation creates devices that are both clinically better and cheaper. While the potential for devices to significantly improve health outcomes is great – and many devices have had such a positive impact – the prevalence of ineffective devices is nonetheless troubling.Footnote ²

In 2016, the 21st Century Cures Act was signed into law.Footnote ³ The Act was designed in large part to accelerate device development and approval. But even under the somewhat stricter regulatory regime that had been in place prior to the Act, there was evidence that ineffective and expensive medical devices were used pervasively. One study identified nearly forty such ineffective medical devices.Footnote ⁴ As shown in Chapter 1, the use of these devices can harm the health of patients and adds significant costs to an already immensely costly system.

Perhaps none of this is surprising given that market mechanisms can be ineffective at promoting ideal device innovation, the regulatory regime is underpowered (even when the Food and Drug Administration (FDA) requires evidence of effectiveness, the bar is low),Footnote ⁵ and the products liability and tort systems do little to force providers to assess relative efficacy.Footnote ⁶ This chapter describes the serious negative consequences that flow from the use of ineffective medical devices and explores some solutions, focusing on the underexplored role that providers and payors might play in beginning to address this problem.

13.1 The Kind of Innovation We Want Versus the Medical Devices We Get

Sometimes medical devices are brand new innovations in that they do not replace anything that came before them. For instance, the stethoscope was first invented in 1816 to improve upon the only method that existed at the time to listen to a patient’s heart – placing one’s ear on the patient’s chest.Footnote ⁷ More often, however, medical devices purport to be improvements to treatments that already exist – an improvement over an existing device (say a next-generation pacemaker) or an alternative to another practice (for example, substituting device technology to control hypertension for pharmaceutical therapy).Footnote ⁸ But how do we evaluate what type of medical device innovation is most desirable?

There are two primary dimensions to consider: the extent to which the device improves patient outcomesFootnote ⁹ and the effect on cost. The best new medical devices simultaneously improve patient outcomes and reduce cost. But we may also be happy when new devices either improve outcomes or are cheaper. One thing is clear: we do not want devices that score poorly on both patient outcome and cost metrics. To the extent our current system is prompting new devices that simultaneously add cost and do not improve patient outcomes,Footnote ¹⁰ that is problematic. Yet there is a growing body of evidence showing that such devices are getting approved (or cleared) by the FDA and are being used in practice, without patient knowledge.

When medical devices are determined to be unsafe, it is front page news. Consider the plight of surgical mesh used to repair hernias that had severe side effects,Footnote ¹¹ the cement application device used in spinal fusions that grew bone where it was not supposed to,Footnote ¹² or metal-on-metal replacement hips that caused flesh-rotting metallosis.Footnote ¹³ These devices were recalled, class action lawsuits were filed, and policymakers rightly focused on how these harms could have been avoided.Footnote ¹⁴ But the same is not true of ineffective medical devices – those that might not be killing people or causing horrendous side effects, but that can nonetheless cause considerable harm when they do not do what they are supposed to do.

Consider the example of the bispectral index monitor (BIS) intended to address anesthesia awareness, which occurs when surgical patients under general anesthesia are aware of events that happened during the surgery after they awaken, sometimes feeling pain.Footnote ¹⁵ These experiences are associated with posttraumatic stress disorder and anxiety. The BIS monitor was designed to fix the problem by measuring consciousness, allowing the anesthesiologist to titrate anesthesia to avoid awareness.Footnote ¹⁶ The device was approved by the FDA in 1996. Its use spread so much that BIS monitors were in more than half of all operating rooms.Footnote ¹⁷ Then, ten years after FDA approval, a large, randomized trial that compared use of the BIS monitor with standardized monitoring procedures found no benefit of the BIS monitor to anesthesia awareness.Footnote ¹⁸ The monitors were not necessarily unsafe, but they were ineffective and costly.

The story of hip protectors is similar. Hip protectors are devices designed to protect older patients, typically who suffer from osteoporosis, from fracturing their hips in a fall.Footnote ¹⁹ The FDA has approved a number of different hip protector devices.Footnote ²⁰ But now, several postmarket studies have been conducted. None have found evidence that hip protectors are effective in preventing hip fractures.Footnote ²¹ In some studies, patients were more likely to fracture hips when using hip protectors than when not.

Mechanical cardiopulmonary resuscitation (CPR) devices provide a final example. When a patient goes into cardiac arrest, delivering high-quality CPR improves patient outcomes.Footnote ²² CPR, however, can be difficult to perform correctly – both to perform chest compressions at the right rate and to compress the chest to the right depth. Mechanical CPR devices ostensibly reduce human error by performing automated CPR at a specified rate and to a specified depth.Footnote ²³ These devices were originally introduced in the 1960s and have been approved or cleared by the FDA.Footnote ²⁴ They are expensive, at an average price of $15,000 each, and are increasingly being used, particularly by EMS agencies.Footnote ²⁵

Counterintuitively, many studies have now shown that mechanical CPR leads to worse patient outcomes than manual CPR, particularly when used outside the hospital.Footnote ²⁶ Mechanical CPR is both more costly than manual CPR and also leads to poorer health outcomes. Yet its use persists.

These examples are likely the tip of the iceberg. While these devices were studied after adoption, most do not get the postmarket randomized trial treatment.Footnote ²⁷ Nonetheless, the systematic study of medical device effectiveness that has been done provides further reason for concern.

In 2019, authors conducted a comprehensive review of the randomized clinical trials published in three leading medical journals – The Journal of the American Medical Association and the Lancet between 2003 and 2017, and the New England Journal of Medicine between 2011 and 2017.Footnote ²⁸ The study aimed to identify medical reversals, which the authors define as “practices that have been found, through randomized controlled trials, to be no better than a prior or lesser standard of care.”Footnote ²⁹ BIS monitors, hip protectors, and mechanical CPR devices, are all medical reversals.

The authors’ review found close to forty medical reversals involving medical devices.Footnote ³⁰ The authors only studied randomized controlled studies that had been published in leading medical journals, but of those studies, a surprisingly high 13 percent of all randomized trials were medical reversals.Footnote ³¹ These findings are consistent with other analyses that have been conducted.Footnote ³²

The next section explores why it is likely that many ineffective devices have prevailed in the market despite the fact that they do not work (or work less well) than other less-expensive options.

13.2 Why Ineffective Medical Devices Are in Use

How exactly do we end up with ineffective medical devices? In theory, three protections should prevent or at least minimize the occurrence: markets, the regulatory regime, and tort law.Footnote ³³ In practice, however, all are flawed.

13.3 The Harm Caused by Ineffective Medical Devices

The harm that flows from unsafe devices is clear. But ineffective medical devices also cause harm – in worse health outcomes and the waste of valuable financial resources. Also, more subtly but still importantly, ineffective devices provide a false sense that problems have been solved, quelling innovation in necessary areas, and engendering mistrust in the health care system.

13.4 Incentivizing Effectiveness

In the current system, ineffective medical devices (and comparatively ineffective ones) are too frequently approved by the FDA and used on patients. Practices concerning these devices are often difficult to stop once they become a part of the standard of care and they can cause both significant patient harm and unnecessary expense. But in order to fix the problem, ineffective medical devices have to be identified, and if they are adopted before identification, there must be a mechanism for discontinuing them. These are not easy problems to solve.

Many scholars promote stricter regulatory standards for ex ante proof of effectiveness.Footnote ⁵⁷ While this would be a logical solution – requiring manufacturers to prove effectiveness before any patients are harmed and any funds are unnecessarily spent – making this change in practice is difficult. There is a strong movement to reform the 510(k) process, which might address those devices that are cleared without any effectiveness review at all. But as to the Class III premarket authorization process, the FDA is under pressure to get devices to market quicker and at a lower cost, which is at odds with tightening effectiveness standards.

One way to address the cost concerns would be for the government to fund this research. But that does not do anything to lessen the overall cost of the endeavor, nor does it address the time-to-market concerns.

The other commonly proposed solution is to improve the postmarket surveillance process – which is already underway with the 21st Century Cures Act.Footnote ⁵⁸ There are initiatives like the National Evaluation System for health Technology (NEST) – a public-private partnership intended to conduct active surveillance on postmarket medical devices.Footnote ⁵⁹ And the Patient-Centered Outcomes Research Institute (PCORI) already conducts postmarket comparative effectiveness research on drugs and devices.Footnote ⁶⁰

The concept is laudable. But as currently conceived, the postmarket surveillance process largely depends on voluntary reporting. The FDA does not have the resources to police and ensure compliance.Footnote ⁶¹ The postmarket surveillance process is also more likely to identify safety concerns than effectiveness concerns. While the FDA can also order postmarket clinical studies, that is generally only in response to adverse events reports. The process could be improved with a registry that requires reporting of all device-related patient outcomes. The registry would have to be actively monitored and analysed to produce useful information.Footnote ⁶²

PCORI’s medical device research intended to aid doctor and patient decision making is also a step in the right direction. But it lacks a mechanism to incentivize using the results of the work. For instance, the law currently forbids government payors from adjusting reimbursement on the basis of PCORI data.Footnote ⁶³

It may be possible to build on these ideas, but the role that both providers and payors play in constraining the use of ineffective devices also deserves more focus. While providers may not often be held liable when devices are ineffective, they would still benefit from better technology that makes their jobs easier and results in better outcomes for patients. In recognition of this, there are initiatives to involve professional societies in the identification of ineffective devices.Footnote ⁶⁴ For instance, the Choosing Wisely campaign tasked medical societies with preparing lists of ineffective interventions, including medical devices.Footnote ⁶⁵ But Choosing Wisely has to have data on which to base its recommendations. It can be helpful in uprooting ineffective devices when new studies suggest lack of efficacy (or when PCORI data does). But providers are unlikely to run or fund studies of devices themselves. Nonetheless, working to change professional norms can be impactful. More broadly, medical education has started to focus decision making more squarely on evidence and data.Footnote ⁶⁶ If providers can learn to rely less on the imprimatur of FDA approval or clearance and more on reliable studies of devices, it can make a big impact.

Perhaps the most promise, however, lies in an expanded role for private payors – and possibly even for government payors. Payors have the motivation to quell the use of ineffective devices.Footnote ⁶⁷ Profit-motivated insurers, but even government payors, benefit from higher-quality, less-expensive care. Payors could make a huge impact by tying reimbursement decisions to data of effectiveness, as is the practice in most European countries.Footnote ⁶⁸

Admittedly, there are many reasons we might be leery of US payors playing this role. Insurers may take an overly aggressive stance in denying coverage, motivated more by profit maximization than by the betterment of patient health and the banishment of truly ineffective devices. Also, medical device efficacy may be heterogeneous. Even if a device is not effective for certain patients, it may nonetheless be for others. This can be hard to discern from studies, particularly if the test population is not diverse. Payors might also not have as much leverage as they do in other reimbursement decisions in a world of limited alternatives.

But the biggest impediment to tying reimbursement to effectiveness data is the lack of the data on which these decisions might rely. Payors are already engaging private technology assessment organizations to do effectiveness analyses, but those assessments are limited by the lack of published data on which to conduct the analyses. So perhaps the better question is what can payors do to incentivize the creation of the necessary data?

Payors may be able to better mine and use their own data to assess effectiveness. Or they could use their bargaining power to incentivize the study of device effectiveness. Payors negotiate with manufacturers over the price the payor is willing to pay for a device. While refusing reimbursement entirely may be impossible, payors can condition reimbursement on manufacturer agreement to fund or participate in a study of device effectiveness. The Government already does this to a limited degree. The Centers for Medicare and Medicare Services (CMS) may conditionally approve reimbursement for a device while requiring that additional evidence be collected about device effectiveness through a clinical trial or device registry.Footnote ⁶⁹

Payors can also play a more active role in steering providers away from devices that may be ineffective based on the results of those studies.Footnote ⁷⁰ In general, payors have bargaining power that could be better employed to promote the study, not just of device safety, but also of device effectiveness.

14.1 Introduction

Multiple outbreaks of antibiotic-resistant bacteria in recent years have been traced to contaminated duodenoscopes in health care facilities in the United States and Europe.Footnote ¹ These events prompted intensive postmarket surveillance of three large duodenoscope manufacturers, the creation of voluntary hospital-based culturing programs,Footnote ² and US Food and Drug Administration (FDA) safety warnings emphasizing the importance of following manufacturers’ instructions for use (IFUs) for performing high-level disinfection (HLD) or sterilization of equipment, also known as reprocessing.Footnote ³ However, as outbreaks continued, the US Joint Commission made high-level disinfection or sterilization of all reusable scopes and probes a central component of its 2018 hospital accreditation programming.Footnote ⁴ This chapter highlights the regulations governing medical devices, the etiology of the duodenoscope outbreaks, and the policy measures implemented and regulatory challenges persisting in the wake of the outbreaks. Given the proliferation of scopes and probes in medical care – including outbreak settings of highly infectious diseases such as the Ebola virus diseaseFootnote ⁵ and carbapenem-resistant Enterobacteriaceae (CRE)Footnote ⁶ – reprocessing cannot and should not remain an abstract part of device regulation. Amplifying the perspective of infection prevention and control in the medical device regulatory landscape is critical to achieve optimal and sustainable reforms.

14.2 Regulatory History and Duodenoscope Outbreaks

Under FDA regulations, devices fall into three classes. Duodenoscopes are categorized as Class II devices, which confer moderate risk and require regulatory controls such as the establishment of performance standards, postmarket surveillance, patient registries, and/or labeling requirements.Footnote ⁷ Class II devices require only premarket notification through the FDA’s 510(k) pathway.Footnote ⁸ By contrast, Class III devices such as implantable pacemakers, which “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury,”Footnote ⁹ require premarket approval (PMA), the most stringent type of device market application required by the FDA.

Yet despite its classification as a Class II device, duodenoscopes were linked to at least twenty-five outbreaks of CRE between 2012 and 2015.Footnote ¹⁰ The actual toll was likely far higher, but unknown given gaps in reporting and surveillance.Footnote ¹¹ By early 2013, the manufacturer Olympus knew of two independent lab reports, which found that one of their duodenoscope models featuring a difficult-to-access elevator channel could harbor bacteria even after cleaning according to the manufacturer’s instructions.Footnote ¹² Even though the FDA began investigating elevator channels in 2013 in collaboration with the Centers for Disease Control and Prevention (CDC), Olympus did not forward the laboratory reports to the FDA or alert US hospitals, physicians, or patients to the risk of infection until February 2015.Footnote ¹³ Further investigation revealed that two major duodenoscope manufacturers failed to pursue a new 510(k) premarket notification prior to bringing their devices with elevator channels to market. Custom Ultrasonics, the manufacturer of an automated reprocessor that was implicated in some outbreaks, also failed to report critical updates to their device to FDA as required by law.Footnote ¹⁴ Finally, the FDA was also unaware of manufacturer warnings to European regulators that had occurred as early as 2013.Footnote ¹⁵

These events highlighted various inadequacies in manufacturer reporting, hospital investigation, and regulator action, which prompted the CDC and FDA to reexamine reprocessing IFUs. In March 2015, the CDC released an interim duodenoscope surveillance protocol for health care facilities in cooperation with the FDA and the American Society for Microbiology (ASM).Footnote ¹⁶ In October of the same year, the FDA ordered three major duodenoscope manufacturers to conduct postmarket surveillance studies to better understand duodenoscope-transmitted infections.Footnote ¹⁷

However, it was not until June 2017 that the FDA promulgated regulations to require manufacturers of certain high-risk reusable Class II medical devices to include validated IFUs regarding cleaning, disinfection, and sterilization in their premarket notification 510(k).Footnote ¹⁸ These regulations acknowledged that the design of some devices, such as those with lumens or crevices, were higher risk than others.Footnote ¹⁹ Additionally, the regulations emphasized the importance of the validated instructions not only for automated reprocessors and washing devices, but also for such high-risk devices.Footnote ²⁰

Over the next four years, the FDA released six general updates of reprocessing instructions, twelve general communications on duodenoscopes, and sixteen public correspondences to duodenoscope manufacturers.Footnote ²¹ In November 2015, there was a mandatory recall of Custom Ultrasonics reprocessors and in February 2018, the FDA, CDC, and ASM released voluntary standardized protocols for duodenoscope surveillance culturing.Footnote ²² Yet in an August 2019 safety communication, the FDA’s postmarket surveillance report noted a continued “elevated rates of contamination, including the presence of high concern organisms” such as E. Coli and Pseudomonas aeruginosa, highlighting persisting concerns of HLD and complex endoscope design.Footnote ²³

These concerns have helped fuel a growing market for single-use equipment, with manufacturers of varying scopes and probes developing completely disposable designs. In November 2019, the FDA recommended transitioning to duodenoscopes with disposable components and one month later, gave market clearance for the first fully disposable duodenoscope.Footnote ²⁴

14.3 Challenges

Amid this backdrop, several practical difficulties and regulatory challenges remain. First, although IFUs for reprocessing higher-risk medical devices must now be validated in accordance with FDA regulation, processes for validation are not standardized and are often unclear. Current FDA guidance refers manufacturers to technical information reports (TIRs) developed by the Association for the Advancement of Medical Instrumentation (AAMI), specifically AAMI TIR 2 (“labeling instructions for reusable medical device”) and TIR 30 (“compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices”).Footnote ²⁵ However, most AAMI TIRs were last published in 2010 and are in critical need of updating.

In 2015, AAMI published the more rigorous “Standard 91: Flexible and semi-rigid endoscope processing in healthcare facilities,” which outlines facility-level quality control practices, addresses human factors issues related to reprocessing, and comments on the design and flow of reprocessing departments.Footnote ²⁶ Yet full implementation of this standard, including cleaning verification processes, schedules, and tracking and tracing of all related endoscope equipment, remains challenging.Footnote ²⁷ Additionally, given rapid advances in disinfection and sterilization science and changes in regulation, this guidance also requires updating.Footnote ²⁸ Work on this has been ongoing since early 2019, but a new draft document had not yet been released as of December 2020.Footnote ²⁹

Thus, over the past decade, manufacturers have largely been left to author IFUs without clear guidance as to what is an acceptable or standard cleaning protocol,Footnote ³⁰ resulting in widespread variation in how IFUs are structured and written, the methods used to demonstrate that effective disinfection has occurred, and storage and handling practices.Footnote ³¹ For example, there are no agreed-upon standards to assess if proper cleaning (e.g., detection of protein versus blood versus microbial DNA) has occurred,Footnote ³² when older equipment should be sent for maintenance, repair, or replacement, or whether borescopes – an optical device – should be used to detect microscopic rips or tears, particularly in otherwise inaccessible cavities.Footnote ³³

Particularly critical to the disinfection process are manual precleaning steps. Although the FDA requires that reprocessing instructions “should be understandable,”Footnote ³⁴ many IFUs are dense and difficult to follow (some IFUs exceed 100 pages). In mandated human factors postmarketing surveillance studies conducted by Fujifilm and Olympus, “most participants expressed some difficulty adhering to the reprocessing manual,” with one study concluding that the materials “are not sufficient to consistently ensure user adherence in these core reprocessing areas: precleaning, manual cleaning, manual high-level disinfection, rinsing, and storage and disposal.”Footnote ³⁵

IFUs can also contradict guidance from professional societies, which can be in conflict with each other. For example, the Society of Gastroenterology Nurses, the Association for Professionals in Infection Control and Epidemiology, and the Association of Perioperative Registered Nurses all have different recommendations on storage and “hang time” – the maximum duration of storage time before the endoscope is processed for next use.Footnote ³⁶ Recognizing such variability, the Joint Commission recently released its own clarification for hospitals, outlining that the IFU remains paramount to professional society guidance and consensus documents. Yet, gaps remain when IFUs are nonspecific or do not address key concerns, leaving hospitals in the position of having to reach out to manufacturers directly.Footnote ³⁷

The interplay between IFUs can also be a challenge. While device manufacturers create their own IFUs, they typically do so separately from the manufacturers of automated reprocessors and high-level disinfectants.Footnote ³⁸ This creates another layer of complexity for end users in health care facilities, particularly those that use manual methods of disinfection. In reconciling IFUs, a hospital’s ability to swiftly recognize concerns and call attention to appropriate leadership can be hampered.Footnote ³⁹ Some device manufacturers of scopes create their own reprocessing equipment exclusively for their own devices,Footnote ⁴⁰ which can mitigate the burden of IFU coordination but can also result in undue contractual leverage, limiting the ability of hospitals to diversify their inventories.

More broadly, concern exists that HLD may be insufficient for scopes.Footnote ⁴¹ The decades-old Spaulding criteria outlines the use of HLD for semi-critical devices such as scopes and sterilization for critical devices such as surgical instruments.Footnote ⁴² Performing HLD typically results in a 6-log₁₀ reduction of micro-organisms, whereas sterilization results in at least a 12-log₁₀ reduction.Footnote ⁴³ However, flexible endoscopes acquire high levels of microbial contamination or bioburden during each use, and may contain tenFootnote ⁴⁴ enteric micro-organisms after use, with buildup around closed channels.Footnote ⁴⁵ Accordingly, some infection prevention experts refer to HLD as creating a “nonexistent margin of safety” that is unable to achieve disinfection consistently.Footnote ⁴⁶

Challenges also exist with sterilization. Typical scope materials cannot handle the high temperatures required for the most commonly available and robust methods of sterilization (i.e., steam).Footnote ⁴⁷ Additionally, existing sterilants have notable drawbacks. For example, ethylene oxide, a sterilant for rigid scopes, requires lengthy processing and aeration time.Footnote ⁴⁸ In high quantities, it also poses health hazards, including carcinogen risk.Footnote ⁴⁹ Because of this risk, ethylene oxide is unavailable in many US hospitals. In 2019, two large device facilities were closed by state environmental protection agencies in response to higher than acceptable levels of ethylene oxide in the air, creating abrupt shortages of sterilized devices.Footnote ⁵⁰

Finally, while the market for single-use equipment may be viewed as a clear path forward, inadequate attention has been given to associated waste streams. Use of disposable duodenoscopesFootnote ⁵¹ would contribute to the market growth of disposable designs for other scopes and probes, but the environmental footprint of single-use equipment has yet to be modeled nationally and internationally.Footnote ⁵² In one study, single-use laryngoscope handles generated an estimated sixteen to eighteen times more lifecycle carbon dioxide equivalents (CO₂-eq) than traditional low-level disinfection of the reusable steel handle, and single-use plastic tongue blades generated an estimated five to six times more CO₂-eq than the reusable steel blade treated with high-level disinfection.Footnote ⁵³ However, some studies suggest higher emissions of C0₂-eq may be offset by the cost of personal protective equipment (PPE), and that the energy consumption of reprocessing equipment also needs to be considered.Footnote ⁵⁴ These comments underscore the need for further data points to build comprehensive models.

14.4 Solutions and Future Discussion

Addressing the above challenges requires engagement between manufacturers, clinicians, regulators, central processing departments, infection prevention and control leadership, and health care administrators. Inconsistencies between IFUs and the lack of transparency and standardization around validation in all domains – precleaning, disinfection, storage, maintenance, and repair – should be key priorities for the FDA and AAMI. Encouragingly, updates to key TIRs are in progress.Footnote ⁵⁵ While working groups developing these documents include diverse stakeholders, including key manufacturers, regulators, and infection prevention experts, TIRs are not made available for public comment.Footnote ⁵⁶ The AAMI standards are made available for public comment, but are solicited by notice in “appropriate AAMI publications or on the AAMI website.”Footnote ⁵⁷ Making drafts of TIRs under review publicly available for comment, and making AAMI standards more widely available for review may present opportunities for improvement and promote swifter uptake by manufacturers and health care facilities.Footnote ⁵⁸ Additionally, ensuring timely and concordant adoption of TIRs by the CMS could help ensure that health care facilities and manufacturers keep up to date.

Even with updated AAMI standards, however, implementation will remain a challenge. To facilitate optimal execution, health care administrators should seek to invest in competency and training programs for reprocessing staff and consider including them in contracted services with manufacturers and vendors.Footnote ⁵⁹ Coordination of IFUs across vendors requires close coordination of health care facility infection prevention and control, biomedical/clinical engineering, supply chain, and contracting departments. While committees comprised of representatives from these groups may be found at many large acute care inpatient centers, they may not exist in ambulatory settings or surgical centers, where procedures are common.Footnote ⁶⁰ The absence of such committees should be considered in a facility’s gap analysis and should be examined as part of regulatory and reaccreditation requirements.Footnote ⁶¹

Since the outbreaks began in 2012, the FDA has expanded its ability to examine the regulatory controls for medical device regulation. The Medical Device Innovation Consortium (MDIC) is a 501(c)(3) public-private partnership with the objective of advancing approaches that “promote patient access to innovative medical technologies and the use of real world evidence in guiding the needs for all stakeholders.”³⁶ As part of the MDIC, the National Evaluation System for Health Technology coordinating center (NESTcc) aims to conduct “efficient and real-world evidence studies throughout the total product life cycle,” to “develop, verify, and operationalize methods of evidence generation” and data use in both the pre and postmarket space, and to bring together stakeholders, including the voice and preferences of the patient.Footnote ⁶² The MDIC patient-centered benefit-risk framework creates decision analysis models that evaluate tradeoffs such as risk of infection or associated length of stay associated with a device that a patient may consider.Footnote ⁶³ However, the MDIC and NESTcc should ensure the completeness of data to inform such metrics. For example, the risks of device-associated infection cannot be properly quantified without understanding real-world gaps in IFUs related to disinfection and sterilization.

The NESTcc could also elevate its voice in the postmarket space. In partnership with the FDA, the MDIC should continue to support and use evidence from medical device safety reporting by hospitals and device manufacturers through portals like the MedWatch and MedSun.Footnote ⁶⁴ The MDIC and the NESTcc could also offer support in the design and development of postmarket surveillance studies. Though small, the human factors studies mandated by the FDA for Fujifilm and Olympus manufacturers in postmarket surveillance were revealing.Footnote ⁶⁵ In particular, they plainly demonstrated the difficulty in adhering to complex IFUs.Footnote ⁶⁶ If these studies were part of active surveillance in the postmarket period, they could offer critical and earlier insight for manufacturers, health care personnel, and the FDA.

In appreciating the pitfalls of complex IFUs, many infection prevention and control experts have called for the reclassification of scopes as critical devices that require sterilization.Footnote ⁶⁷ There is regulatory precedent for such action. In 1992, the FDA mandated a shift from disinfection to sterilization for dental handpieces, even though there were no documented cases of disease transmission associated with dental hand pieces.Footnote ⁶⁸ Professional societies should support this transition, and accreditation agencies should start developing standards to facilitate institutional accountability.Footnote ⁶⁹

Incentives will likely be needed to encourage further development of sterilization options, including low temperature sterilization technologies (LTSTs). The FDA recently started this process, announcing in November 2019 four participants in an “innovation challenge” to identify disinfection and sterilization alternatives that can be implemented at a large scale and maintain high throughput.Footnote ⁷⁰ Two of these participants will focus on the use of vaporized hydrogen peroxide technology that is currently being used on a large scale to disinfect respirators during the COVID-19 pandemic.Footnote ⁷¹ While participation does not constitute “regulatory acceptance,” manufacturers should expect that the FDA remains committed to expeditiously clearing LTSTs as they are developed if safety and effectiveness standards are met.³⁸ In turn, manufacturers should commit to the FDA’s endorsement of creating scopes with innovative designs, including manufacturing scopes with materials that are compatible with LTSTs.Footnote ⁷²

More recently, the FDA announced a second innovation challenge to decrease ethylene oxide emissions.Footnote ⁷³ In parallel and in light of closures of sterilization facilities due to high ethylene oxide emissions, the US Environmental Protection Agency (EPA) issued a notice of proposed rulemaking to solicit information from industry and the public on strategies for further reducing ethylene oxide emissions from commercial sterilization and fumigation operations. This includes reviewing and updating regulations for sources that emit ethylene oxide and to better understand and address ethylene oxide emissions at facilities.Footnote ⁷⁴ Such interagency coordination will be needed to more identify the optimal role of ethylene oxide in medical device sterilization, the effects of endoscope sterilization, and the impact on the supply chain and transportation operations.Footnote ⁷⁵

Finally, hospitals and clinics will need to consider the far-reaching impacts of incorporating disposable equipment, especially as pathogens of high consequence such as CRE, take hold.Footnote ⁷⁶ Hospitals and clinics will need to partner and engage early with major biomedical waste companies and recycling vendors both in the United States and globally to create a regulated, functional waste stream.Footnote ⁷⁷ These groups will need to understand large throughput hospital- and clinic-based workflows, calculate new labor costs, and consider implications for their supply chains. Corporate social responsibility platforms should expand to account for the impact of such activities and integrate this work into ongoing sustainability efforts, including tracking fleet and incinerator emissions.Footnote ⁷⁸ To more fully weigh complete environmental impact, cradle-to-grave lifecycle assessment and lifecycle costing methods should be used.Footnote ⁷⁹ For example, the EPA’s Tool for the Reduction and Assessment of Chemical and other Environmental Impacts can be used to model environmental impacts of greenhouse gases and other pollutant emissions.Footnote ⁸⁰ As is required to examine ethylene oxide impacts, a sustained FDA and EPA partnership can help, facilitating detailed data gathering to inform national and international economic and environmental analyses. This effort should discuss how to weigh energy consumption of reprocessing departments and facilities, human labor costs, and PPE usage.

While the NESTcc represent the FDA’s efforts to modernize the 510(k) process, the FDA will need to embed both the perspectives of infection control and environmental sustainability to transform its approach.Footnote ⁸¹ In particular, understanding the tradeoffs associated with sustainable production and consumptions practices can shift the FDA approach from reactive to proactive.Footnote ⁸²

14.5 Conclusions

High-level disinfection and sterilization of medical equipment has slowly evolved over the past three decades. The outbreaks of drug-resistant bacteria traced to contaminated duodenoscopes offer a case study in understanding the gaps in medical device regulation. Although the FDA has made strides in closing these gaps, important and critical problems persist; the concerns exposed in the duodenoscope outbreaks expand beyond scopes and spans larger concerns around device design, cleaning, disinfection, management, uptake and care. Together, these experiences call for a greater voice for infection prevention and control in the medical device ecosystem. The NESTcc and the FDA’s ongoing private-public partnership consolidate national efforts for medical device safety: minimizing disease transmission and considering environmental harms should be part of that mission.

In vitro fertilization (IVF) led to approximately 74,590 births in 2018.Footnote ¹ IVF success rates have increased roughly three-fold since the first live birth in 1978. Yet today the chance of giving birth using IVF is barely better than a coin toss, even for the youngest, healthiest patients.Footnote ² Scientists and industry are pursuing methods to improve IVF success rates. However, many clinics seem unconcerned with the effectiveness of new methods. Marketing of these methods, so-called IVF “add-ons,” to vulnerable patients seeking to start a family has led to calls for greater regulatory scrutiny.Footnote ³

Add-ons include methods such as selecting the “best” sperm in a semen sample, or artificially “activating” eggs to prepare embryos for transfer to a uterus.Footnote ⁴ They run from a couple hundred dollars to more than ten thousand dollars. Data on their utilization is limited, but one estimate suggests that 74 percent of fertility patients used at least one add-on.Footnote ⁵

Most notoriously, the practice of preimplantation genetic screening or preimplantation genetic testing for aneuploidies (PGS or PGT-A) is used to identify (and usually discard) embryos that show an abnormal number of chromosomes.Footnote ⁶ Mounting evidence illustrates that the $6,000–$12,000 test is not a good predictor of whether an embryo will develop into a healthy baby; one estimate suggests that approximately 40 percent of healthy embryos may have been unnecessarily discarded based on PGS results.Footnote ⁷ While the test may accurately identify cells exhibiting aneuploidies, many questions remain regarding whether and how those results predict the health of a child resulting from the embryos tested. This means that many patients’ hopes at biological parenthood may have been squandered due to their reliance on an expensive, erroneous test. To date, there has been no regulatory activity in the United States to stop clinics from making claims about, providing, or charging for PGS testing.

This chapter describes the genesis of the direct-to-consumer nature of the US fertility services market that makes consumers uniquely susceptible to offers of unproven technologies in hopes of increasing their likelihood of pregnancy success. It explores the many modes of regulation in the United States and their shortcomings as well as the limits of the Food and Drug Administration’s (FDA’s) lack of jurisdiction over embryos and the tests used to select and modify them. In light of these limitations, the chapter concludes by posing a two-pronged path forward to address the most pressing concerns about add-ons: 1) amendments to existing federal law to require fertility clinics and labs to report a list of all services they offer patients and tie their utilization to rates of success and 2) Federal Trade Commission enforcement action against clinics who make deceptive and/or unsupported claims about add-ons and other technologies.

15.1 Fertility Services Direct-To-Consumer Market

Modern assisted reproduction in the United States is a health care anomaly. First, fertility treatments are not consistently covered by private or public insurance, although coverage has increased in recent years. Consumer patients are cost-sensitive and will select providers based upon particular services offered.Footnote ⁸ Patients do not benefit from signals of necessity or quality from insurance companies’ coverage decisions. People seeking fertility treatments rely heavily on the Internet and fertility center websites to inform their choices.Footnote ⁹ The resulting direct-to-consumer fertility markets makes the veracity of claims made by clinics critical to ensure consumers make informed choices. Yet, most fertility clinic websites do not comply with the guidelines outlined by the American Medical Association or the industry’s own self-regulatory body.Footnote ¹⁰

The medical component of the fertility industry does not act alone. Physician-run clinics interact with other for-profit players including multi-million-dollar sperm banks and agencies that broker provision of sperm, eggs, embryos, and surrogacy services. These transactions take place outside the context of any physician-patient relationship and contribute to the transactional atmosphere of fertility services. The market creates competition for patients and an incentive for providers to distinguish themselves by offering services that could improve patient consumers’ likelihood of success.

Second, fertility innovation has been left to rely on private funds due to a ban on government funding.Footnote ¹¹ Public funding triggers ethical obligations in developing new technologies, including informed consent requirements. Without public funding, fertility innovation occurs free from restrictions placed on most biomedical research. Coupled with its transactional nature, it is no surprise that fertility clinics offer and sell unproven add-ons in order to attract patients. At best, this means that empowered consumers are knowingly subsidizing the development of unproven technologies in hopes they might be lucky. At worst, vulnerable consumers are being exploited to spend significant funds for futile or harmful services they believe increase their odds of success.

The dangers of add-ons seem to be precisely the type of threat to public health that state medical boards and the FDA are designed to address – to eliminate unsafe or unproven medical interventions from the market or to “assur[e] the safety, effectiveness, quality, and security”Footnote ¹² of medical interventions. Could the FDA not regulate these new technologies as medical devices applied to the earliest forms of human life? These questions are addressed in the following sections.

15.2 The US Fragmented Patchwork of ART Regulation

Federal oversight over the Assisted Reproductive Technology (ART) industry is well discussed within the academic literature and the popular press. Many have called the United States the “wild west”;Footnote ¹³ however, as one of the editors of this volume points out, a number of mechanisms moderate behavior in US ART markets, resulting in a fragmented patchwork of regulation.Footnote ¹⁴ In fact, the American Society for Reproductive Medicine (ASRM) claims that “Assisted Reproductive Technologies are among the most regulated medical procedures in the United States.”Footnote ¹⁵

If the United States is the “wild west” of ART, it is not because there are no sheriffs in town. There are multiple sheriffs, mayors, and informally deputized leaders each trying to address their own overlapping concerns. Some of these regulations and private law controls are discussed in this section.

15.3 FDA Regulation of Reproductive Technology Devices (or Embryos?)

The FDA’s regulation of ART is limited to its authority under the Food Drug and Cosmetic Act (FDCA)Footnote ²⁹ and the Public Health Services Act (PHSA).Footnote ³⁰ The jurisdictions of the FDA depends upon how a technology is used and how embryos are characterized. Coherently regulating many facets of ART under the FDCA and/or PHSA would require the FDA to decide: if an embryo is legally equivalent to a human warranting protection and the objects of regulation the devices used to manipulate it, or if the gestating human is to be protected and the embryo the object of regulation as a “biological product” or “drug” used to create a pregnancy. The legal, ethical, and political implications of such a determination may be one of many reasons the FDA has not actively exercised enforcement powers over add-ons and why categorization of embryos and ART innovations remains unclear. Since 2015, Congress has signaled annually that it does not want to empower the FDA to make determinations with such vast societal implications.Footnote ³¹

The FDA has classified one device used to manipulate embryos for implantation. This move implicates its jurisdiction over such devices; it also illustrates that it may be an ineffective regulator even if doing so is a proper exercise of its jurisdiction.

15.4 Moving Consumer Protection (and Innovation) Forward

In many ways, the HFEA in the United Kingdom provides the ideal example for the United States to adopt.Footnote ⁴⁹ It would consolidate oversight into a central, federal agency and provide consumer-centric information to inform decision making. However, federal action to create a new agency charged with overseeing embryos and the fertility industry is not a pragmatic resolution for many of the same reasons a change to the FDA’s charge is unlikely.Footnote ⁵⁰

Similarly, state action to regulate in this space may be difficult. Even if state action is plausible, forum-shopping lessons learned from areas related to ART governed by state law (such as surrogacy) teach us that national-level control is desirable. In light of these limitations, I propose a two-pronged solution: 1) amendments to FCSRCA to require fertility clinics and labs to report a list of all services it offers patients, and 2) enforcement by the FTC. In sum, the approach taken almost thirty years ago to rein in fertility clinics overstating their success rates should be similarly utilized to protect consumers from unproven add-ons that claim to improve success.

First, Congress should amend the FCSRCA to require clinics and labs to report a list of services it offers to its patients, particularly those it lists on its website and in promotional materials. In addition, it should expand reporting to link utilization of those technologies with the success rate reporting already required such as confirmed pregnancy and live births. While such a system would not offer the gold standard of randomized controlled trials for new technologies, it would generate retrospective studies to provide indicators of effectiveness. The additional reporting could provide an imperfect postmarket surveillance mechanism. As noted above, the FDA has underperformed in postmarket activity even in areas in which its regulatory power is clear. If a clinic is consistently selling its patients laser-assisted hatching but there is no evidence that it improved rates of success, clinics could be held accountable for representations made to patients about the value of assisted hatching.

Revisions to the FCSRCA could also include a mechanism by which the CDC, much like the United Kingdom’s HFEA, could grade innovations based upon the data collected, and disseminate the evaluation publicly. This proxy for necessity/value addresses one of the unique problems posed by the direct-to-consumer nature of fertility services and could fill the void left by the lack of insurance providers’ coverage decisions. Fertility market consumers’ propensity to turn to the internet for guidance regarding fertility treatments suggests this could be an effective way to protect them from paying for unproven services. In addition, the data could be used by the FTC to trigger disclamatory language requirements or limit the types of representations that players in the ART market can make to consumers.

Amendments to the FCSRCA are politically feasible. Expanded reporting requirements do not involve governmental judgments regarding when life morally and legally begins. Moreover, the current political moment resembles the conditions that gave rise to the FCSRCA in 1992 – there is growing concern with new technologies thanks to popular press coverage.

To address pushback from the industry due to the cost of additional reporting requirements, Congress could make the legislation more attractive by limiting the FDA’s role as it did regarding in the original FCSRCA, and explicitly place embryos and the devices used to manipulate them outside of the FDA’s wheelhouse. Reporting requirements may seem like an inexpensive price to pay for protection from a more cumbersome regulatory scheme like premarket FDA approval.

Second, the FTC should exercise its enforcement power against clinics and labs that make unsubstantiated claims about the efficacy of add-ons. Given previous FTC activity on the heels of FCSRCA’s passage, amendments to the FCSRCA and the public attention that could follow may be a good catalyst to motivate FTC enforcement. Expending federal funds is justified in light of the size of the fertility market. This work undertaken in conjunction with an updated FCSRCA would allow the FTC to gauge the veracity of claims clinics make about the ways the services they provide improve the likelihood of success. This is strikingly similar to the claims the FTC brought in the 1990s when clinics inflated or used deceptive methods of calculation to inflate about their IVF success rates.

As for those claims that may not go so far as to be deceptive but raise concerns given the consumer reliance on the clinic’s expertise, FTC regulation of over-the-counter drugs and cosmetics advertising may be a helpful analogy to consider; it requires advertising to be truthful and substantiated by evidence.

In addition, FTC enforcement could apply across other parts of the fertility industry, including sperm, egg, and surrogacy brokers, and could be a centralized “sheriff.” For example, sperm and egg banks make problematic representations regarding the traits and anonymity of sperm and egg providers. The FTC could provide an effective mechanism to address these concerns.

15.5 Conclusion

Consumers are willing to pay an unusually high emotional, physical, and financial price to have a chance at becoming a genetic parent. The evolution of the consumer-centric US fertility market and inefficient patchwork of overlapping regulatory bodies and legal systems has left them without sufficient safeguards against purchasing unproven interventions to increase their likelihood of success. The FDA is the familiar actor to protect patient consumers from unproven treatments; however, it is not clear if it is legally empowered to exercise jurisdiction, and it is undesirable and infeasible for Congress to expand its purview.

Greater FTC enforcement and legislation to expand reporting requirements represent politically feasible, appropriately consumer-protective, and innovation-preserving options to address the challenges posed by innovation in this unique industry. Hopefully, these changes will avoid a repeat of the devastating reality faced by many patients whose embryos were perhaps prematurely discarded and protect intended parents from harmful or opportunistic behavior in an already physically, emotionally, and financially draining process.