FDA LDT Regulation

On June 16, 2010, the U.S. Food and Drug Administration (FDA) announced its intention to dramatically expand its regulatory oversight of laboratory-developed tests (LDTs). For years, the FDA had adopted a policy of “enforcement discretion” in declining to closely regulate LDTs. However, an expanding and changing LDT marketplace, along with heightened government and media scrutiny of certain LDTs, including high-complexity tests and tests marketed directly to consumers (DTC), has caused the FDA to reconsider its policy of enforcement discretion. This page aggregates all of the Genomics Law Report’s coverage of the FDA’s ongoing attempt to develop a comprehensive system of oversight for LDTs

Conley Q & A on LDTs and the FDA

FDA v LDTIn her recent post on the FDA’s draft guidance on its proposed oversight of Laboratory Developed Tests (LDTs), Jen Wagner mentioned my interview with Genome Web’s Turna Ray on January 15, 2015. Turna asked me to address some arguments made in a “white paper” written by former U.S. Solicitor General Paul Clement and Harvard law professor Laurence Tribe on behalf of their client, the American Clinical Laboratory Association. The main point that Clement and Tribe made was that the FDA lacks legal authority to oversee LDTs, at least in the way that it’s proposing to do so. As I told Turna, I don’t necessarily disagree with their position; in fact, I’m skeptical about the FDA’s authority to do this. Also, like Jen, I’m not persuaded the proposed FDA initiative is likely to work well from a practical perspective. Nonetheless, I agreed to play along in a devil’s advocate exercise, making the counterarguments I’d make if representing the FDA. Here’s a brief summary of my arguments:
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Groundhog Day: FDA and Proposed Oversight of LDTs

FDA v LDTOnce again, attention in Washington, DC has turned to the Food and Drug Administration (FDA) and its proposed oversight of all laboratory developed tests (LDTs). The occasion for this attention was the FDA’s separate releases on October 3, 2014 of its proposed LDT framework and proposed notification and medical device reporting guidance. The former describes the basic structure for how the FDA intends to exercise its authority over LDTs as medical devices (e.g., risk classification and enforcement discretion categories), and the latter describes the process by which laboratories offering LDTs must notify the FDA of all LDTs (i.e., registration) and the adverse event reporting requirements that would apply to LDTs as medical devices (i.e., reporting of deaths, serious injuries, malfunctions, etc.). The agency hosted a public meeting on January 8-9, 2015 to discuss the proposed guidance and is accepting written public comments until February 2, 2015. [No joke: Comments are, in fact, due on Groundhog Day.]

• Comments on the proposed LDT framework (Docket No. FDA-2011-D-0360) can be submitted here.
• Comments on the proposed notification and medical device reporting (Docket No. FDA-2011-D-0357) can be submitted here.

The public meeting featuring speakers and panelists was organized into six topical sessions covering test components and labeling; clinical validity and intended use; categories for continued enforcement discretion; notification and adverse event reporting; classification and prioritization; and quality system regulation. The FDA has promised to post the transcript (and, in the meantime, some live tweets from the meeting will remain available on @DNAlawyer’s feed). Dr. Jeff Shuren started the meeting with a reminder that the FDA’s proposed guidance was based on discussions held five years ago, in 2010. (Prior GLR coverage is here.)
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Long-Awaited Announcement from the FDA on LDTs

FDA v LDTOn July 31, 2014, the FDA gave Congress notice that in the next 60 days it would be announcing draft guidelines on the regulation of laboratory developed tests (LDTs). This topic has been discussed on the Genomics Law Report frequently for years. [You can access the previous coverage here].

The “Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” mark a large expansion of FDA regulatory activity into industry practices that have been–depending on your perspective on the scope of the agency’s regulatory power—enjoying the FDA’s discretionary forbearance from regulation or taking place just outside of FDA’s regulatory reach. Indeed, aside from a few “it has come to our attention” letters in Summer 2010 and the second, more forceful warning letter issued to 23andMe in Fall 2013, the FDA has not taken action against companies providing individuals with direct-to-consumer (DTC) access to their personal genetic/genomic information.
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FTC Takes Action to Protect Consumers from False Genetic Advertising Claims

600px-US-FederalTradeCommission-Seal.svgFor the past few years, discussions regarding the regulatory oversight of direct-to-consumer (DTC) genetic tests have focused heavily on one agency: the FDA. Attention has grown since 2010 when the FDA began hinting the agency would broadly regulate laboratory developed tests (LDTs) and has only intensified since the issuance of the infamous cease-and-desist letter issued to 23andMe in late 2013. Now 23andMe and the FDA are hitting the reset button to begin the long road to restore 23andMe’s Personal Genome Service® one condition or trait at a time (the company announced on June 20, 2014 that it has filed, and the FDA has accepted for review, its first 510(k) application for Bloom Syndrome). The personal genomics industry continues to wait anxiously for the FDA proposed rules on DTC genetic tests, which are on the FDA’s Draft Guidance “B-List” for FY2014 (i.e., DTC genetic tests are not among the FDA’s top priorities).

Perhaps it’s time another administrative agency is brought into the discussion. This year the Federal Trade Commission (FTC) has taken its first actions to protect consumers of genetic tests. The FTC has broad authority to protect consumers from unfair and deceptive trade practices (including false and misleading advertising claims) under Section 5(a) of the FTC Act, 15 U.S.C. 45(a)(1). The FTC also enforces posted corporate privacy policies. The FTC filed charges against two companies in January (Genelink, Inc. and its former subsidiary foru™ International Corporation) and filed charges against a third company in June (L’Oreal USA, Inc.) for “purported personalized genomics products.” The charges related to the marketing of nutrigenetic and dermagenetic products. The matters against the first two companies were resolved by settlement approved on May 12, 2014. The FTC announced a proposed settlement of the charges against L’Oreal on June 30, 2014.
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What does the FDA Approval of the MiSeqDx Platform Mean for DTC?

FDA v DTCOn November 19, 2013—three days before the highly-publicized warning letter to 23andMe (See here and here)—the U.S. Food and Drug Administration announced that it had given approval for the marketing of four Illumina MiSeqDX medical devices. They include two cystic fibrosis genetic assays as well as the Illumina MiSeqDX instrument platform and Illumina Universal Kit reagents. The FDA’s press release characterizes them as “devices that can be used for high throughput gene sequencing, often referred to as ‘next generation sequencing’” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA (deoxyribonucleic acid).

What does the FDA’s approval of the MiSeqDx platform for the clinical market mean for the DTC industry? For example, does this mean that 23andMe could just switch platforms from the Illumina HumanOmniExpress-24 format chip to MiSeqDx and be free from future FDA meddling? Could new companies enter the industry free from regulatory burdens by using Illumina’s MiSeqDx platform? Don’t bet on it.

It is likely that the FDA would take the position that its 510(k) premarket approval (a process John explained briefly on December 3) of the MiSeqDx instrument and MiSeqDx Universal Kit was not intended to be a blanket “go ahead” for DTC providers to offer a service like 23andMe’s Personal Genome Service®. Rather, it is more likely that the FDA would insist on review and pre-market approval of MiSeqDx as an next-generation sequencing in vitro diagnostic (or NGSIVD) if it were used for any purpose other than return of raw genomic data (i.e., if any interpretation were provided along with that raw data). It is also unclear to what extent these FDA approvals will allow future applicants to rely on the approved MiSeqDX products as “predicate devices” to clear some of the regulatory hurdles more easily. (Specifically, the future applicant would claim that its device was “substantially equivalent” to the already-approved device.)

The FDA’s own press release nowhere mentions a non-patient consumer. The press release emphasizes how next-generation sequencing technologies are “becoming more accessible for use by physicians,” underscoring the FDA’s continued insistence that clinicians be the gatekeepers for accessing information about one’s genome. The press release states front and center: “The new technology also gives physicians the ability to take a broader look at their patients’ genetic makeup and can help in diagnosing disease or identifying the cause of symptoms.”

The FDA’s approval of the MiSeqDx platform is thus intriguing, but the future regulation of DTC genomic testing remains uncertain. The 510(k) approval of the MiSeqDx platform may signal that raw data provided DTC might be acceptable to the FDA but that interpretation of that genomic data in any way related to health would still provoke FDA scrutiny and, possibly, hostility. Could a DTC provider use the MiSeqDx platform and successfully argue that its interpretation of raw data is a Laboratory Developed Test (LDT; a test manufactured and used within a single CLIA-certified lab) and, therefore, potentially outside the reach of the FDA? We can’t say for sure at this point. As for the implications of this for 23andMe, as I reported on December 6, current indications suggest that the company is still trying to gain FDA approval of its Personal Genome Service.

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Update: 23andMe appeases FDA

FDA v LDTIn an effort to quiet the storm, 23andMe has announced that it does intend to continue seeking FDA approval and that, while that process is ongoing, it will no longer provide health-related information to new customers. Customers whose Personal Genome Service® kits were ordered prior to November 22, 2013 will still have access to that information; however, customers whose PGS was ordered after the FDA warning letter will only have access to ancestry information and their raw data. The company also announced that it would offer a refund to those who ordered the PGS on or after November 22, 2013.

So is this a victory for the FDA? Is this a loss for 23andMe? A setback for consumers? A win for anyone?
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Reader Response . . .

James P. Evans, Bryson Distinguished Professor of Genetics & Medicine and Editor-in-Chief of Genetics in Medicine, responds to my post on the FDC “warning letter” to 23andMe:

I liked your piece – with one exception. You say you are “libertarian” in the medical realm. This could make sense if you paid for all of your medical care. But you don’t – and I warrant even Bill Gates doesn’t. We’re all in some kind of insurance scheme, be it private or public. Thus, the libertarian argument (“It’s my body, I want this test/treatment/etc”.) doesn’t fly in my mind.

When medical tests are misused, we all pay – even if you pay for the initial test itself – because of downstream costs. If I give someone antibiotics inappropriately because they make the libertarian argument and even offer to pay for the prescription out of pocket, the problem is that the complications of antibiotic resistance may well cause downstream complications for them that their insurance (and thus I) have to pay for.

By the same token, if people use that argument to get inappropriate complex testing (e.g. a 23andMe profile or a whole-body MRI), we all end up paying for the (inevitable) downstream costs. Simply put, we all have a stake in seeing that complex medical tests are used appropriately. Thus, the FDA’s action was entirely reasonable and appropriate.

So, since your hand is in my pocket when it comes to medical care, I just don’t see the libertarian argument working, even putting aside my concerns about harm to people (which we all, I think, want to avoid) and my (admittedly paternalistic) view that we have to protect people from slick advertisements and themselves.

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If 23andMe Falls in the Forest, and There’s No One There . . .

FDA v LDTGenomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease and desist letter sent by the FDA to 23andMe – in two posts — by Jennifer Wagner and by John Conley.

On November 22, 2103, the Food and Drug Administration issued a “warning letter” to Google-backed 23andMe demanding that the company “immediately discontinue marketing” its Saliva Collection Kit and Personal Genome Service (PGS), a direct-to-consumer (DTC) genomic testing service. The letter states that 23andMe markets the PGS as a source of “health reports on 254 diseases and conditions,” and “specifically as a ‘first step in prevention’ that enables users to take ‘steps toward mitigating serious diseases’ such as diabetes, coronary heart disease, and breast cancer.” Consequently, the FDA concludes, the PGS is a medical device subject to FDA regulation, as opposed to a mere source of information, as 23andMe has long contended. Because 23andMe has not obtained required approvals, the FDA claims the authority to order its removal from the market.

The letter has already generated tremendous interest in the media and among investors. Jen Wagner and I have been deluged with questions from both groups. Here are my thoughts on some of the most frequently asked questions. As you’ll see, my overall reaction is: calm down, take a deep breath, it’s not that big a deal. Jen has posted her views here.
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The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease & desist letter from the FDA to 23andMe.

FDA v LDTGenomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease and desist letter sent by the FDA to 23andMe – in two posts — by Jennifer Wagner and by John Conley.

A brief background for the newcomers

23andMe, Inc. was founded in 2006. Its personal genomics service launched in 2007 and was named Time Magazine’s Invention of the Year in 2008. Just before the Thanksgiving holiday in 2009, 23andMe split its all-in-one service into two separate editions for ancestry and health and raised its price. The following year, just before the 2010 Thanksgiving holiday, 23andMe scratched its business model with separate health and ancestry editions in favor of a return to the all-in-one service with a new mandatory annual subscription fee. By June 2011, the company boasted 100,000 users and in late 2012 lowered its price to $99 to aim for one million users. Recently, 23andMe ramped up its marketing, launching its very first TV ad campaign called “Portraits of Health” in August 2013.

Company’s run-ins with the FDA

On June 10, 2010, the company—along with several other direct-to-consumer (DTC) providers—received a cease & desist letter from the FDA. A full two years later, on July 30, 2012, the company touted it was the first of its kind to
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The FDA, Social Media & Consumer Genomics: A Lot Not to “Like”

pharma-social-mediaLast week, the FDA published on its website a warning letter to AMARC Enterprises, Inc., a marketer of a dietary supplement known as Poly-MVA. (Here is the company’s description of the supplement.) While the letter is not addressed to a high-profile company or product, given that the FDA’s action will likely have broader significance beyond just AMARC and its Poly-MVA supplement, all currently or potentially FDA-regulated entities, including consumer genomics companies, should take note.

The AMARC letter, issued by a regional compliance office and dating to this past December, is unremarkable in most respects. The majority of the letter focuses on website copy, printed information packets, customer testimonials and other materials that appear, at least to the FDA, to represent claims made by AMARC that the Poly-MVA supplement is “intended for use in the cure, mitigation, treatment, or prevention of disease,” thus making it a drug subject to FDA regulatory approval.


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