DOJ Presses for Reforms of APA

The U.S. Administrative Procedure Act (APA) came into being in 1946, but by some accounts hasn’t been subjected to a serious overhaul in the intervening 74 years. However, the Department of Justice has made the argument that the time has come to revisit the language in the APA, and has bipartisan Senate legislation to back the argument.

The Aug. 11, 2020, DOJ statement includes a link to a report that summarizes the findings of a December 2019 summit on the measures that might bring the APA more into line with modern circumstances. The report, titled “Modernizing the Administrative Procedure Act,” is largely a transcription of the discussions at the summit, but the report also cites previous efforts to amend the APA due to concerns that the statute has not worn well with the passage of time.

Among these was a push for reform by the Second Hoover Commission in 1955, but another pressing consideration is the sheer cost of regulation. Deputy Attorney General Jeffrey Rosen estimated that the aggregate annual cost of federal regulation is as much as $2 trillion a year, a sum one speaker said would represent the ninth largest economy in the world if that figure represented a nation’s gross domestic product.

Multiple Legislative Proposals, No Votes

The APA has not gone untouched in the 74 years since its passage, but many of the changes, such as the 1967 Freedom of Information Act, have been additive in nature rather than attempts to substantially overhaul the APA. Several bipartisan bills have emerged in Congress recently to address the drift of the APA toward functional senescence, including the Regulatory Accountability Act of 2017 (S. 951). Among its other provisions, S. 951 would have required federal agencies to conduct public hearings preparatory to development of rules with an anticipated economic impact of $100 million or more.

Another feature of the bill is a requirement that federal agencies must disclose all data and other sources of information used in rulemaking per the Portland Cement doctrine. The administrative requirement of a cost benefit analysis for rules would also become part of the statute via S. 951. That bill never came up for a vote, however.

There is also some interest in the Independent Agency Regulatory Analysis Act (S. 869), which would subject independent federal agencies to the same requirements as other agencies. This includes the economic impact analysis requirement for rules that are estimated to impose an economic cost of $100 million, but this bill was never put to a vote in the Senate Homeland Security and Government Affairs Committee.

Despite the absence of legislation, the Trump administration has taken measures, including Executive Order 13,771, which is said to have led to a reduction in the volume of new federal rules from the average of 279 rules between 2000 and 2016 to 61 in 2017 and 2018. According to the related entry at the Office of Information and Regulatory Affairs, this executive order has eliminated more than $13 billion in costs across government in 2019 and an overall total of nearly $51 billion since 2017.

As might be expected, the Brand memo receives some attention in connection with administrative activities, given that it bans the use of federal agency guidance as an indicator of violations in civil and criminal matters pursued by the DOJ. Rosen said in his presentation that federal agencies are sometimes inclined to issue guidances in lieu of rulemaking in an attempt to avoid the relatively cumbersome rulemaking process, but as a result, private sector entities may find themselves unavoidably in conflict with one or more guidances that may be difficult to locate.

While the summit took place prior to the onset of the COVID-19 pandemic and thus might be counted as a casualty of the pandemic, DOJ’s revival of the question signals an interest in renewing the push for reform of the APA. The impending election suggests, however, that any related legislation will not emerge until December at the earliest, with calendar year 2021 perhaps a more likely target date.

September a Guidance Drop Month for FDA

September was an unusually busy month for the FDA’s device center, which released more than 20 draft and final guidances in the final 30 days of fiscal 2019. Several of these documents are related to the de novo device program, but the agency also updated its approach to the humanitarian device program as required by recent legislation.

Humanitarian Use Guidance Updated
The final guidance for the FDA’s humanitarian device exemption (HDE) program explains how the agency determines whether the sponsor has demonstrated a probable benefit, although the final encodes the new limit for humanitarian use devices of 8,000 per year as seen in the 21st Century Cures Act. Another change due to statutory mandates, in this case the Food and Drug Administration Reauthorization Act of 2017, is that the sponsor need not rely on a local institutional board, a change intended to offer some efficiencies in the conduct of multi-site clinical investigations.

The HDE guidance is applicable to devices reviewed by both the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. HDE applications will be reviewed within 75 days under this policy, a much quicker turn-around than is available to PMA devices at 180 days. Device makers are now allowed to make a profit on these devices unless the volume sold exceeds the annual distribution number limit of 8,000, and manufacturers are required to file an annual report on profitability only if the price charged for the device exceeds $250.

De Novo Program Rates Three Guidances
The agency also released three guidances pertaining to the de novo premarket program, including the final guidance spelling out the actions both device makers and the agency can take in relation to these applications. Also topical for the agency’s purposes is how those actions might affect review goals under the current user fee program.

The FDA said the clock will stop on a de novo application should the agency have questions that cannot be answered in a reasonable amount of time, although the guidance does not provide any metrics for “reasonable.” The hold goes into effect when the FDA issues the request, and the guidance states that a request for additional information stops the review clock and “marks the end of an FDA review cycle.” The clock will resume once the agency is in receipt of a complete response from the sponsor.

De novo submissions are now subject to user fees, and the target turn-around time for de novo petitions is 150 days, although the percentage of applications that must meet that deadline varies by year. For fiscal 2018, the target ratio of applications that met the 150-day target was 50%, but that goes up to 70% in the final fiscal year of this user fee schedule, which is FY 2022. The review staff assigned to that application will be available to discuss any problems with the sponsor if it is still outstanding at 180 days, at which point the reviewers will discuss next steps, including the deadlines for completion of those next steps.

The final guidance for acceptance review of de novo applications employs the same refuse-to-accept (RTA) principles that govern RTA policies for 510(k) and PMA applications. One important difference for the de novo version is that the sponsor has to document that there is no cleared predicate on the market, assuming the device in question is not a class III device. The FDA staff is tasked with determining whether any 510(k) or PMA applications are in process for devices with the same technology and same indication for use.

There are a number of considerations for de novo applications that are combination products, including whether the drug component for a drug-device combination product is the subject of a patent. The guidance includes a checklist which the sponsor is advised to complete prior to filing the application with the FDA. The checklist starts with four questions regarding whether the device in question is a combination product, highlighting the agency’s interest in resolution of any combination product questions before the de novo reaches the FDA.

Three for 2018; New Year Off to a Fast Start

Those in the life science industries know better than to sleep on the courts and the FDA, and the first quarter of 2018 serves to nicely reinforce this lesson. Following are three stories of interest to drug and device makers, but while its clear that the outcomes of these developments are of tremendous importance, it is not at all clear where these three stories will land in the end.

Gilead Moves Closer to Cert 

One of the more notorious cases relating to the Federal Rules of Civil Procedure is Campie v. Gilead, but the Supreme Court will have at least two such cases to choose from thanks to a petition Medical Device Business Services, Inc. v. United States ex rel. Nargol. The problem for this latter case is that it seems to overlap with Gilead, and Gilead has been distributed for conference for April 13, suggesting that Nargol will for now stand as decided at the Court of Appeals for the First Circuit.

Gilead had petitioned for cert on Dec. 26, 2017, while Medical Device Business Services, once known as Nargol v. DePuy Orthopaedics Inc., completed its petition for cert Feb. 5 after requesting an extension in the first half of December 2017. MDBS v. Nargol takes up the issue of the Federal Rule of Civil Procedure 9(b), a dispute triggered by the fact that the two relators in this False Claims Act case never filed a billing claim for the purportedly violative device, and apparently do not even practice medicine in the U.S. The relators, who served as expert witnesses in a case against MDBS, built their claims largely around an extrapolation of one medical claim to all the billings for the company’s Pinnacle hip device, and the petitioner points to a split among the circuit courts as justification for a hearing at the Supreme Court.

Gilead Sciences Inc. petitioned for cert after the Ninth Circuit reversed a lower court’s dismissal of the case, which revolves around the use of an unapproved supplier of an active pharmaceutical ingredient. The company eventually cleared the new API source with the FDA, but not until two years after Gilead started doing business with the supplier. In this instance, the relators are former employers, and Gilead cites the Supreme Court decision Universal Health Services v. Escobar as a precedent, which MDBS does not. All in all, it seems likely that the Supreme Court will take Gilead if it takes either of these cases.

Intended Use Rule Back on Back Burner

The FDA’s intended use problem continues seemingly unabated with the announcement that the agency would suspend the intended use rule indefinitely pending a closer look at some of the underlying issues. The tobacco-related portions of the January 2017 final rule are unaffected, but the portions of the rule dealing with drugs and devices are once again in regulatory limbo. The agency said it has in the meantime reverted to the previous understanding of the question of intended use.

The Federal Register notice regarding this indefinite suspension states that some had criticized the inclusion of the totality-of-evidence standard seen in the January 2017 final rule, principally because that standard had not appeared in the 2015 draft and thus its introduction in the final rule violated the Administrative Procedures Act. While there are a number of other issues raised by stakeholders, the totality-of-evidence standards was perhaps the most contentious, and if anything can be said about the FDA’s current predicament, it’s that the agency cannot afford to sit on this issue indefinitely because some states are moving ahead with their own laws pertaining to commercial speech, federal preemption notwithstanding. Those in the life science industries will want to stay tuned.

Least Burdensome Draft Draws Fire

The docket for the latest draft guidance for the FDA’s least burdensome standard has closed, but a number of observers are quite skeptical as to whether the agency means what it says about the principle of least burdensome.

The FDA’s Center for Devices and Radiological Health released the latest draft guidance at the end of 2017, acknowledging at the outset that the standard was encoded in the statute in 1997 via the Food and Drug Administration Modernization Act. Two subsequent pieces of legislation, including the 21st Century Cures Act, also applied pressure on the agency to formalize the least burdensome standard. Nonetheless, Jeffrey Gibbs of Hyman, Phelps & McNamara said in comments to the docket that the agency has engaged in “boilerplate recitation” of the standard without actually following through.

Gibbs charged that experience has repeatedly shown that the agency has inconsistently, at best, applied the least burdensome standard in a range premarket filings, including 510(k) and PMA submissions. He argued that the agency’s reviewers have routinely failed to explain the need for data beyond that used to clear a predicate device in the case of 510(k) submissions, and similar devices in the context of PMA applications.

Gibbs urged the agency to offer applicants a conference call within five days of the issuance of a request for additional information for premarket filings, a proposal he said builds off a pilot program that offers applicants “a short teleconference” within 10 days of the request. He said this pilot offers only about 15 minutes of teleconference time with the application’s reviewers, an amount of time he suggested is inadequate.

The Medical Imaging & Technology Alliance said the draft invoked the question of medical necessity when the agency has to consider what sort of least burdensome enforcement action is needed to deal with violative devices. MITA’s executive director, Patrick Hope, countered that medical necessity is a standard for payers to determine, and that the association is “concerned about the potential for scope creep” should the medical necessity question play a role in the agency’s decisions.

FDA Introduces Portal for Public Reporting of Regulatory Misconduct

Kate T. Klaus, Esq. | Staff Attorney, Medmarc Loss Control

Earlier this week, FDA launched a new program in which individuals can report, directly to FDA’s Center for Devices and Radiological Health, allegations of regulatory misconduct on the part of medical device manufacturers and marketers. The agency understands very well the vast reach of the medical device industry, but its limited resources have allowed bad actors to market their products while attempting to remain below FDA’s radar. In addition to creating potential risks for patient safety, this flouting of regulations has long been a source of frustration for medical device companies that do operate within the bounds of the law and feel unfairly disadvantaged when competitors skirt the rules.

Examples of reportable misconduct include:

  • Advertising or promoting a device beyond the bounds of its indications for use;
  • Marketing a device without the necessary clearance or approval;
  • Failing to implement or comply with necessary Quality System requirements;
  • Importing devices that do not meet U.S. legal criteria;
  • Failing to register and list with FDA, thus preventing FDA from properly overseeing operations; and
  • Knowingly deceiving FDA in some fashion, whether falsifying documents or hiding information.

Reports are accepted through the FDA webpage, as well as by mail and email. While FDA encourages reporters to include their name and contact information in the event that additional information is required, reports can be filed anonymously. FDA will review the reports, evaluate potential risks to public safety, and determine the appropriate intervention or enforcement action.

What is the takeaway for medical device firms? For those already operating in compliance with FDA regulations, there should not be a burdensome impact. Even if FDA chooses to investigate an allegation, frivolous claims will likely be dispensed with easily when met with strong quality systems and thorough recordkeeping practices. However, for those firms attempting to fly beneath FDA’s radar, they may find themselves on the receiving end of a Warning Letter in short order. Your competitors have been watching your practices for years, but FDA has now empowered them to act.

For more information on compliance with FDA regulations, please see our Life Sciences Guidebook, available for sale on Amazon.

The Yates Memo, One Year Later

The Yates memo hit the trade and legal press with the same kind of resounding thud that accompanied previous DoJ memos such as the Thompson memo, and indeed, more than one prosecution has resulted in the imposition of fines imposed on corporate officers as expected. However, the memo has also affected the way companies think about directors and officers liability insurance thanks in part to the potential for the Yates memo to conquer by dividing.

Deputy Attorney General Sally Quillian Yates inked the memo that bears her name in September 2015, a seven-page document that makes its aims clear in the second paragraph. Yates, whom the Senate confirmed to the position a scant four months earlier, said in the memo, “one of the most effective ways to combat corporate misconduct is by seeking accountability from the individuals” believed to have been involved in the wrongdoing.

Yates stopped short of some of the more extreme prescriptions found in the memo named for one of her predecessors, Larry Thompson, whose January 2003 memo seemed excruciatingly close to requiring that corporations leave their executives and officers without the benefit of their directors and officers (D&O) liability policies, not to mention the hazard Thompson’s memo had introduced to attorney-client privilege.

Nonetheless, the Yates memo might seem to drive a wedge between employer and employee. By some accounts, corporations must divulge any and all information about anyone who was involved in the purportedly violative conduct in order to engender any forbearance at all on the part of a federal prosecutor.

If anyone needed to see evidence of this dual individual-corporate accountability at work, the case of North American Health Care provided that evidence. The Department of Justice announced in mid-September that it and NAHC had come to terms over allegations the company had induced false claims for rehabilitation services. The company agreed to pay more than $28 million to settle the case, but two of the company’s executive staff lost a total of $1.5 million, thus demonstrating that Yates meant what she said about individual accountability.

The size of the NAHC penalty was not conspicuous, given the $1.5 billion fine paid by Abbott Labs in 2012 over the company’s promotion of Depakote for off-label indications. On the other hand, the Yates memo would seem to add a new wrinkle to the question of D&O insurance inasmuch as corporations and individuals might have a different set of incentives regarding cooperation. Depending on the circumstances, corporate officers may feel compelled to seek their own representation, particularly when documents begin to show up in a prosecutor’s briefcase.

In addition to the fact that individuals may have less incentive to cooperate than their employer, more than one director or officer could opt for independent counsel, thus raising the cost of fulfilling contractual obligations to provide counsel. In some instances, the cost of counsel for all the affected parties could quickly exhaust the policy’s liability limits.

These considerations are obviously high on the list for a candidate for an executive position with a company or a seat on the board of directors, and those in the life science industries are keenly aware of the intense government scrutiny of their activities, particularly since the FDA off-label promotion issue is as yet unresolved. One way to deal with some of these considerations might be to add a supplementary policy for directors and officers that will handle issues such as a prosecution of individuals that continues after the corporation has come to terms with federal attorneys. There are other considerations to sort through as well.

The Yates memo might not have a profound effect on the size of penalties imposed on accused companies, but adding corporate officials to the list of those who are subject to prosecution certainly raises the stakes where legal costs are concerned. Companies in the life sciences can’t afford to wait until a federal attorney comes knocking to ensure their policies cover such considerations.

Hot Topics & Technologies in Life Sciences

Medmarc Loss Control

When asked to come up with a list of what’s hot in life sciences right now, Medmarc’s Risk Management team put our heads together and came up with the following list.

  1. Off-label Promotion Revisited
  • Following the recent case involving Amarin Pharmaceuticals, FDA is reconsidering the extent to which it will permit companies to make truthful and non-misleading statements about off-label uses as they relate to clinical decision making, research, and reimbursement.
  • FDA will hold a public hearing on November 9 and 10 as part of a comprehensive review of its regulations and policies regarding off-label promotion.
  1. Unique Device Identifier (UDI) – Extended Deadline
  • Under the UDI directive, Class II devices were supposed to be in compliance with the law’s label and GUDID (pronounced “Good ID”) rules by September 24, 2016. The same provision also eliminated the use of National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers and replaced them with the UDI codes.  Suppliers and pharmacies rely on NHRIC and NDC numbers to identify products, including for reimbursement purposes, and are unprepared to eliminate the use of these numbers.  In response to industry objections, FDA has agreed not to enforce the prohibition against NHRIC and NDC numbers until September 24, 2021.
  1. New Rule on Antibacterial Soaps
  • On September 2, 2016, the FDA issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
  • This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
  1. Point-of-Care Diagnostic Testing
  • Currently, the diagnostic testing model has the provider taking samples for testing and outsourcing the analysis to a diagnostic laboratory (such as Quest Diagnostics), which involves a several day wait for test results. However, in line with the push toward preventive and personalized medicine, medical device firms are seeking to improve upon this model by offering equipment for in-office and portable diagnostic testing.
  • Alere and Roche are the current market leaders, offering point-of-care diagnostic testing for cardiometabolics (e.g., blood gases), infectious disease, toxicology, oncology, women’s health, anticoagulation therapy, and urinalysis.
  • The point-of-care model raises questions about software validation and maintenance as well as the inherent cybersecurity challenges.
  1. The Fall of Theranos
  • Known as the blood-testing start-up founded by Elizabeth Holmes as a 19-year-old Stanford dropout, Theranos was once valued at some $9 billion when a damning report published in The Wall Street Journal alleged that the company was, in effect, a sham—that its core technology was actually faulty and that Theranos administered almost all of its blood tests using competitors’ equipment.
  • The FDA investigated two Theranos sites and issued two 483s, finding that Theranos kept poor records, mishandled complaints, failed to conduct quality audits, and was “unable to produce documented supplier qualifications,” among other observations.
  • CMS imposed sanctions on the company in July 2016, prohibiting it from receiving Medicare and Medicaid payment for lab services and imposing a civil monetary penalty, among other sanctions.
  • The company is also under investigation by the SEC and FBI.
  1. Zika Lab Tests
  • Zika testing is used to detect infection in a person without signs and symptoms or to determine whether a person with signs and symptoms of Zika has been infected after exposure in a region with Zika virus. It may also be used to test people who have had sexual contact with a recent traveler to a region with Zika.
  • Zika infection may be difficult to diagnose without laboratory tests because symptoms may resemble those of other diseases, such as dengue fever or chikungunya infection.
  • FDA has been allowing the emergency use of some yet-unapproved Zika tests. To do so, FDA uses the Emergency Use Authorization (EUA) procedure (under the Food, Drug & Cosmetic Act), which allows use of the unapproved product for a specified duration of time. The FDA website lists ten Zika-related products currently approved on this basis.
  1. Cool New Technology Alert – Augmented Reality
  • Augmented reality—a blend of virtual reality and one’s real-world surroundings—looks like it may have some real beneficial uses in medicine. In 2014, the FDA cleared an augmented reality device for surgeons to use in preparation for surgery, and other devices may appear in surgical suites before long. Using these devices, surgeons can visualize the patient’s anatomy from outside of the body, by constructing a holographic overlay created from CT scan data.
  1. “Dirty” Endoscopes
  • Endoscopes, and particularly duodenoscopes, have long been recognized as high-hazard devices due to their design (i.e., the flexible neck of the scopes allows for bacteria to become trapped, potentially eluding cleaning). Olympus, a major scope manufacturer, was forced to recall thousands of its scopes following the discovery that its devices harbor bacteria that could not be eliminated even when the company’s own instructions for disinfection were followed. As a result, there were several deaths and more than 200 infections of CRE (carbapenem-resistant enterobacteriaceae), which has a significant mortality rate─some reports cite rates as high as nearly 50%.
  • This incident refocused industry attention on scopes. A German company has developed a robotically-assisted, sterile, single-use colonoscope. Because the device is single-use, it eliminates the risk of bacteria transmission between patients – assuming hospitals follow the instructions not to reuse the device, which has been an issue in areas with scarce resources.
  1. Software & Predictive Analytics
  • Several recent studies reveal that certain software and predictive analytics tools can better identify and predict the presence and path of health conditions among patients than trained doctors and pathologists.
  • The capability of the software raises questions about how the FDA will regulate them and to what extent they should be used—merely as clinical support for decision-making, or as independent diagnostic tools.
  • In its mobile medical apps guidance, the FDA specifically declined to address software “that performs patient-specific analysis to aid or support clinical decision-making.” Thus, the Agency has not interpreted such as being medical devices so far. However, if used independently to diagnose conditions, these software programs would likely come under the FDA’s scrutiny as medical devices.
  1. Cybersecurity & Device Breaches
  • Insulin pumps, heart monitors, x-ray communications systems and other medical devices have been shown to be vulnerable to cyberattack. Accordingly, there is much concern about the security of patient information entered or stored in medical devices or the cloud in the “internet of things” in which multiple devices communicate with one another.
  • In light of such concerns, and news of breaches in hospitals and insurance networks, the FDA has published cybersecurity guidance for medical-device makers to ensure the security of patient information the devices gather.

New California and Illinois Opinions Force Drug Companies to Litigate Out-of-State Plaintiff Cases in California and Illinois

Jordan Lipp, Esq. | Partner, Davis Graham & Stubbs LLP

In the last week, the California Supreme Court and the Illinois Court of Appeals have each issued opinions finding that their respective states had personal jurisdiction to hear lawsuits by out-of-state plaintiffs against out-of-state defendant drug companies.

On August 29, 2016, in Bristol-Myers Squibb Co. v. The Superior Court of San Francisco County, — P.3d –, 2016 WL 4506107 (Cal. 2016), the California Supreme Court in a 4-3 decision addressed the issue of personal jurisdiction in a case where 678 individuals, consisting of 86 California residents and 592 nonresidents, all alleged adverse consequences from the use of Bristol-Myers Squibb’s drug Plavix.  Bristol-Myers Squibb is incorporated in Delaware, headquartered in New York City, with substantial operations in New Jersey.  The lawsuits were filed in San Francisco Superior Court.

On the issue of general jurisdiction (i.e., whether a defendant can be sued in the forum regardless of whether the case is related to the forum), the Court stated that “although the company’s ongoing activities in California are substantial, they fall far short of establishing that it is at home in this state.”  However, on the issue of specific jurisdiction (i.e., whether the case-linked conduct occurred in the forum), the Court found that Bristol-Myers Squibb’s national marketing, promotion, and distribution of Plavix in California, coupled with its research and development facilities in California, created specific jurisdiction, even with respect to the out-of-state plaintiffs.  Although the majority opinion stated its decision did “not render California an all-purpose forum for filing suit against [the defendant] for any matter,” the dissent warned that the “the majority [decision] expands specific jurisdiction to the point that, for a large category of defendants, it becomes indistinguishable from general jurisdiction.”

Only a few days earlier, on August 26, 2016, in M.M. v. GlaxoSmithKline LLC, 2016 Ill. App. LEXIS 575 (Ill. App. 2016), the Illinois Court of Appeals for the First District addressed whether the Circuit Court of Cook County, Illinois had specific jurisdiction over GlaxoSmithKline in lawsuits brought by 12 nonresident plaintiffs against GlaxoSmithKline based upon the drug Paxil.  Although GlaxoSmithKline is based in Delaware and does not have corporate or administrative headquarters in Illinois, the Illinois Court of Appeals found that personal jurisdiction existed over GlaxoSmithKline.  The Court reasoned that as the Plaintiffs’ allegations involved GlaxoSmithKline’s alleged errors during its clinical trials of Paxil, which partially occurred in Illinois, these Illinois clinical trial actions established specific jurisdiction.

While Daimler AG v. Bauman, 134 S. Ct. 746 (2014) and other recent decisions have given hope to drug and device companies that they will not be sued in forums other than their home states, especially in cases where the plaintiffs also do not reside in the forum state, neither the California nor Illinois decisions advance this cause.

Life Sciences News Roundup, 6/30/2016

  • Code of Conduct on Privacy for mHealth Apps Finalized by EU – Medical Product Outsourcing
  • Study: Initially CE Marked Medical Devices Have Higher Recall Rate – Mass Device
  • The Defend Trade Secrets Act’s Implications for Medtech – MD+DI
  • China FDA Releases New Self-Assessment Reporting Requirements for Medical Device Distributors – Inside Medical Devices (Covington)
  • Medical Device Companies Feat Parallel Regulation After Brexit Vote – Mass Device

Stepped Up Regulation of Lab-Developed Tests Has Products Liability Implications

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

Significant advances in science, and particularly in genomic medicine, have catapulted lab-developed tests (LDTs)–diagnostic tests designed, manufactured, and used in the same laboratory–past the benign uses they fulfilled decades ago. When LDTs were used with relative infrequency and often for a crucial segment typically neglected by in vitro diagnostic (IVD) manufacturers–namely, rare diseases–they received lax oversight from the FDA under what the Agency deems its “enforcement discretion.”

Now though, in the wake of well-publicized disasters like Theranos and the realities of both (1) the huge cost incentives to use these “home brew” tests over FDA approved tests that can cost as much as ten or twenty times as much; and (2) the transformative effect of genomic testing advances which have meant LDTs are now employed to test everything from birth defects to ovarian cancer, the FDA has undertaken to significantly step up its oversight and require pre-market approval for many such LDTs.

According to the first of three draft guidance documents on the Agency issued on the subject in the last two years, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), it proposes a risks-based oversight strategy under which those tests the wrong result or interpretation of which would have the greatest implications for patient mortality or morbidity would receive the most stringent oversight and have to obtain pre-market approval prior to their use.

This stepped-up oversight isn’t merely burdensome to labs making LDTs; it has real products liability implications. For one thing, a company’s misstep with the FDA in the form of an enforcement action or inspection is often either an initial attractant or a catalyst for plaintiffs’ attorneys. Knowing that these kind of regulatory missteps are helpful at trial to paint a picture of a non-compliant, careless manufacturer, plaintiffs’ attorneys may seek grounds for suits after learning of a company’s FDA trouble.

Additionally, standards and regulations are useful to products liability plaintiffs in establishing a standard of care, one hurdle of a negligence case (the next being showing that the defendant deviated from that standard of care). The more detailed and complex the regulations, the easier it is to find some lapse in consistency with them.

LDT makers must be quick to recognize the burdens of their new regulatory environment and adapt accordingly. Quality assurance/regulatory affairs personnel should be hired or engaged as soon as possible to avoid regulatory and products liability consequences.