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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Filed under Badges, FDA LDT Regulation, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Pending Regulation

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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Filed under Direct-to-Consumer Services, FDA LDT Regulation, Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation

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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Filed under FDA LDT Regulation, General Interest, Industry News, Legal & Regulatory

Property Rights and the Human Body

11808967A Canadian court made headlines this month when it decided, as a preliminary matter, that human tissue removed from the body for diagnostic medical tests is “personal property” that belongs to the hospital where the procedure was performed. The case was a medical negligence action brought against two doctors by the estate of Snezana Piljak, a woman who was diagnosed in 2009 with colorectal cancer and died in 2011. At issue in the case is whether the doctors were negligent in failing to diagnose the cancer in 2008 when a colonoscopy was performed on Ms. Piljak. The doctors had petitioned the Canadian court for access to liver tissue biopsied from Ms. Piljak in 2009 at Toronto’s Stonybrook Hospital. The court had to address the matter of tissue ownership before it could consider whether the defendant-doctors had a right to access the liver tissue in order to investigate whether Ms. Piljak had hereditary non-polyposis colorectal cancer (HNPCC or Lynch Syndrome). If the HNPCC were indicated by an examination of the tissue, the defendant-doctors would use that fact to mount a defense against the accusations of negligence. The court ruled that the tissue was personal property of the hospital (though it ultimately denied the defendant-doctors’ request to examine it for technical reasons). The decision that human tissue is “personal property” has important legal ramifications that might affect the biotech industry and genetic research community outside of Canada. The question of ownership of biospecimens has often been tangled up with the status of the biospecimens as personal property, though they are distinct questions.
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Filed under Biobanking, Genomics & Medicine, Genomics & Society, Patents & IP, Privacy

Judicial and Legislative Reactions in California to Maryland v. King, 133 S. Ct. 1958 (2013)

window where the light gets inThis year’s first news in the area of genetics and criminal law comes to us from California, where both the judicial and legislative branches are reacting to the U.S. Supreme Court decision in Maryland v. King. In Maryland v. King, the Supreme Court upheld DNA fingerprinting as a routine booking procedure for serious crimes as authorized by Maryland’s DNA Collection Act. Justice Kennedy’s opinion in King indicated it was intended to be a narrow ruling, focused on the specific facets of Maryland’s state statute. This narrow scope effectively left other DNA fingerprinting schemes open to constitutional challenges if they could be distinguished from the details of the Maryland statute. Among those schemes are California’s Proposition 69 and the Federal DNA Fingerprint Act of 2005. The latter scheme was upheld en banc (all the judges of the circuit sitting together, rather than in the usual three-judge panel) by the Third Circuit Court of Appeals in United States v. Mitchell in 2011 (United States v. Mitchell, 652 F.3d 387 (3rd Cir. 2011) (en banc), pet. for cert. filed (Nov. 22, 2011) (No. 11-7603, 11A384), cert. denied – S.Ct. – (Mar. 19, 2012).
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Filed under Genetic Testing/Screening, Genomics & Society, Privacy

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.

Filed under Badges, Direct-to-Consumer Services, FDA LDT Regulation, Genomic Policymaking, Genomic Sequencing, Industry News, Legal & Regulatory

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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Filed under Badges, Direct-to-Consumer Services, FDA LDT Regulation, Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Pending Regulation, Uncategorized

Troubles keep coming for 23andMe

As if the FDA warning letter wasn’t enough, 23andMe, Inc. now has a lawsuit on its hands. The suit, known as Casey v. 23andMe, was initiated on November 27, 2013, in federal court for the Southern District of California (Case 3:13-cv-02847-H-JMA). The suit is being brought as a class action and on the general basis of breach of implied warranties, unjust enrichment, and misrepresentation.
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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Pending Litigation, Uncategorized

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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Filed under FDA LDT Regulation, General Interest, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Legal & Regulatory

Revisions to the Ethical Standards for Research

HelsinkiThe World Medical Association published revisions to the Declaration of Helsinki (DoH) in JAMA on October 19, 2013. As noted previously on the Genomics Law Report, the DoH was adopted in 1964 and is considered a foundational guiding document for ethical medical research. The DoH has been revised six times previously, and these are the first revisions since 2008. The revised DoH was announced following the Working Group’s public consultation from April to June 2013 on the text of proposed changes, though the Working Group has apparently spent at least two years contemplating revisions and consulting with experts. In the United States, the DoH has been an important foundational document promoting the creation of institutional review boards (IRBs) but has had relatively little practical influence since it was effectively abandoned by the administration of former President George W. Bush. Nonetheless, the DoH continues to exert significant influence over international ethical standards.
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Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Informed Consent, International Developments, International News