Genomic Policymaking
The Business Effects of Regulatory Uncertainty in Genetic Testing
The business of genetic testing has progressed rapidly, if unevenly, over the past several years. Like any business based on new and rapidly developing science, the promise of new products and markets is counter-balanced by the obstacles of developing commercial products from raw science, fostering markets for those products, constructing profitable business models and overcoming novel legal and regulatory hurdles.
The Regulatory Environment Turns Negative. Until May 2010, the regulatory challenges in the genetic testing world seemed relatively benign, with most attention focused on patent and related IP issues (e.g. the Myriad gene patent litigation) and a challenging economic climate which made commercial operations and capital raising difficult for most businesses.
The Cost of Regulating LDTs
Jeffrey N. Gibbs is a director at the law firm of Hyman, Phelps & McNamara and specializes in FDA-related matters.
For many years, the Food and Drug Administration (FDA) has taken the position that while it has the authority to regulate laboratory-developed tests (LDTs) as devices, the agency would exercise its enforcement discretion and not do so. More recently, FDA has taken a series of steps that backtrack from that approach, and indicated that it intends to regulate at least some LDTs as devices. Whether FDA has the legal authority to regulate LDTs or whether the agency can do so without going through notice-and-comment rulemaking will be hotly debated. The issue of whether FDA regulation is necessary or beneficial will also trigger sharply differing views. What is not debatable is that the regulation of LDTs as devices under the existing device regulatory regime, should it occur, would have a significant effect on the laboratories offering the tests that are regulated as devices, and will increase the regulatory costs for assays.
Congress has given FDA the authority to comprehensively regulate medical devices. The imposition of these regulatory requirements upon LDTs will have a profound impact on those tests. The following outlines some of the key elements of FDA’s medical device regulatory scheme, and explores the effects of the application of those requirements to LDTs.
The Genomics and Personalized Medicine Act Returns to Congress
Meggan Bushee is a student at the Wake Forest University School of Law.
This past May, Congressman Patrick Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) re-introduced a personalized medicine bill to the U.S. House of Representatives. The bill was originally introduced in 2006 by then-Senator from Illinois Barack Obama. While HR 5440, also known as the Genomics and Personalized Medicine Act of 2010 (GPMA 2010), has retained the name of the bill originally introduced by Senator Obama, its approach to the regulation of personalized medicine has taken a new direction.
GPMA 2010 is the fourth version of the GPMA since the original bill of 2006, and includes the most ambitious initiatives of all of its predecessors. Why has the GPMA re-surfaced after three prior versions failed to make it out of committee? According to Representative Kennedy, the bill has been re-introduced in response to increased public awareness and use of genomic tests. At present, GPMA 2010 is before the House Committee on Energy and Commerce. This is the same committee that recently conducted high-profile hearings to review the current state of the direct-to-consumer (DTC) genetic testing registry.
Swine Still Soaring: Federal Circuit Judge Expresses Sympathy for Myriad Analysis
Back in March, we headlined our discussion of the district court judgment in the Myriad case “Pigs Fly.” Guess what?—they’re still aloft. On August 4, in a highly technical patent case that, appropriately enough, involved “porcine virus DNA,” one Federal Circuit judge—dissenting Judge Timothy B. Dyk—suggested that he might agree with the basic principle of the Myriad holding: that isolated DNA sequences are not necessarily patentable.
Judge Dyk’s comments were a bolt out of the blue, as he raised an issue that had not been addressed by the parties or the lower court. Because he is a member of the court that will decide Myriad in the next year or so, Judge Dyk’s comments might be more significant than the district court opinion itself. (The case is Intervet Inc. v. Merial Ltd., Fed. Cir. 8/4/2010.)
Resolution in Florida Wrongful Birth Case
Tom Clarkson is a student at the University of Georgia School of Law.
The “Wrongful Birth” debate is in the news yet again. In a pair of previous posts (here and here) the Genomics Law Report highlighted several issues relevant to the debate over what happens when states recognize a cause of action for wrongful birth, wrongful life or wrongful conception. A recent example from Florida illustrates that the debate continues.
Aiden, Caleb and Smith-Lemli-Opitz. In 2002 Aiden Estrada was born with a number of severe birth defects. Despite multiple examinations, Dr. Boris Kousseff, Director of Medical Genetics of the University of South Florida College of Medicine, failed to diagnose the symptoms as Smith-Lemli-Opitz syndrome and informed Aiden’s parents that they could expect a “normal” pregnancy if they conceived again. Relying on these representations, Amara and Daniel Estrada conceived a second child in 2004. This second child, Caleb, was born with symptoms nearly identical to those of his brother Aiden. Within one hour of Caleb’s birth, a geneticist at the University of Florida diagnosed him with Smith-Lemli-Opitz syndrome. The Estradas sued, and a Florida jury awarded them more than $20 million dollars in their wrongful birth suit in July 2007.
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The Past, Present and Future of DTC Genetic Testing Regulation
[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision.
On Tuesday, Carmichael and five commentators examined what can be learned from a DTC genetic test. Yesterday, the topic was whether DTC genetic tests are trustworthy, and whether the results can be cause for concern. Today’s topic is the regulation of DTC genetic tests. In addition to several short commentaries, including a much shorter version of the piece below, Carmichael has also posted a lengthy interview with two top FDA officials on the subject of DTC genetic testing regulation.
The column below is an expanded version of what appears over at Newsweek. To see all of the commentaries in Carmichael’s series, click here.]
The recent media attention focused on direct-to-consumer (DTC) genetic tests has left companies, investors, consumers and even regulators scrambling to figure out what comes next.
As the situation stands today, companies and their investors live in a climate of unprecedented regulatory uncertainty, causing delays in the introduction of new products and rendering an already inhospitable economic climate – for both fundraising and sales – even more challenging. Commentators and regulators caution consumers that some DTC genetic tests may be unreliable or, worse, harmful, but have yet to provide clear tools and guidelines for evaluating competing tests. And regulators, including the FDA, must balance their mandate to protect the health and safety of the public with that same public’s desire for autonomy, while also recognizing that innovation is a prerequisite for a healthcare system that must continue to improve outcomes while reducing costs.
Clearly, something must change. But what will that change be? And how will the field of DTC genetic testing evolve? Will DTC be able to continue its current business while regulators and companies engage in protracted negotiations? Will oversight weed out the “snake oil salesmen” and permit legitimate companies to flourish? Will it drive all genetic testing (temporarily) out of the hands of consumers?
Or will the field change in a dramatic and completely unexpected way?
“From Gulf Oil to Snake Oil”: Congress Takes Aim at DTC Genetic Testing
It has been a busy week in Washington for direct-to-consumer (DTC) genetic testing companies. Following public FDA meetings and a new round of FDA device notification letters earlier in the week, representatives from three major DTC genetic testing companies (23andMe, Navigenics and Pathway Genomics) were hauled in front of Congress today to defend their companies, their industry and the practice of DTC genetic testing.
The hearing on “Direct-To-Consumer Genetic Testing and the Consequences to Public Health” was conducted by the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations. The meeting was chaired by Representative Bart Stupak of Michigan. Materials from the hearing, including a briefing memorandum, opening statements from Stupak and Representative Henry Waxman of California and witness testimony are available on the Committee’s website. Also available are materials from the Government Accountability Office (GAO) investigation into DTC genetic tests. These materials include the report the GAO submitted to Congress – “Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices” (pdf) – as well as a YouTube video featuring excerpts from undercover phone calls made by the GAO to DTC companies as part of their investigation (both of which are discussed in detail below).
While You Were Meeting: FDA Mails Letters to 14 More Genetic Test Providers
Earlier this week the FDA held a widely publicized two-day public meeting to discuss its planned regulation of laboratory developed tests (LDTs) (for more see: Day One Recap and Day Two Recap). Other than Monday morning, when the FDA presented background information on LDTs and some of the considerations that have pushed the Agency to pursue a “risk-based application of oversight to LDTs,” the top Agency officials at the meeting were conspicuously quiet. Elsewhere, however, the FDA was doing plenty of talking.
In letters dated July 19th, the first day of the FDA’s public LDT meeting, the Agency continued its crackdown on direct-to-consumer (DTC) genetic test providers, mailing letters to 14 providers of genetic tests. A list of all 14 companies and tests appears below.
The Conversation Continues: Recap from Day Two of FDA’s Regulatory Meeting
The second and final day of the FDA’s “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs) brought forth many of the same comments and themes as the first. The primary difference was that, whereas the first day began with some comments from the Agency that provided a few hints about what the FDA has in store for LDTs, the second day was notable for the FDA’s near-total silence (although key officials were present and listening). Indeed, perhaps the loudest applause of the day was reserved for Sharon Terry of Genetic Alliance, who remarked that while she was glad the FDA had invited so many comments, “it would be nice [if the Agency] would say something back.”
Something Old, Something New. In addition to a reiteration of yesterday’s themes – especially the need for additional data demonstrating how LDTs are used and what harms, if any, they have inflicted on consumers and patients – a few new areas of discussion emerged over the course of the day. Those included:
The Conversation Begins: Recap from Day One of FDA’s LDT Regulatory Meeting
Welcome to Hyattsville, MD, where we have just completed day one of FDA’s two day “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs). The session was civil, well-organized and largely devoid of surprises. It did, however, mark the official kick-off of the FDA’s highly publicized decision to develop a “risk-based application of oversight” for all LDTs.
If you’re interested in the details of what was said and by whom you’ll find links at the bottom to all of the relevant transcripts, video feeds and Twitter coverage. For my part, here are the three key take-away points from day one:
Timing. Last week I wrote that it was unlikely that this meeting, or any of the other myriad regulatory and legislative proposals for LDT regulation, would produce a significant shift in the legal and regulatory landscape any time soon. One day of FDA meetings has done nothing to change that opinion.
