Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least the opportunity – of accessing and interpreting their own genetic information. Over the past year, several state legislatures have taken notice.
Following on the heels of legislation passed or proposed in California, Vermont and Massachusetts, the Alabama House of Representatives is considering a bill by Representative Henry (pre-filed on January 23, 2012 and scheduled for first read on February 7, 2012) titled the “Genetic Information Privacy Act” (2012 AL H.B. 78). While the bill is relatively brief, its effects as written may reach far beyond those intended.
A New Bar for Informed Consent. First, the bill in its current form would require signature on separate informed consent documents to obtain, retain, or disclose genetic information. As drafted the bill would provide an exception for the insurance industry, permitting a single, integrated informed consent document if the genetic information is being obtained, retained, or disclosed “for the purpose of obtaining insurance” (Page 4, Line 25).
With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.
Continuing Uncertainty Over FDA’s 510(k) Overhaul. As we have discussed previously, in addition to overhauling the approval process for direct-to-consumer (DTC) and laboratory developed tests (LDTs), the FDA is also in the midst of a comprehensive review of its 510(k) clearance process for medical devices.
Back in December, the National Institutes of Health (NIH) refused to exercise the government’s “march-in” rights under the Bayh-Dole Act with respect to the patent-protected drug Fabrazyme® (agalsidase beta). A group of Fabry disease patients had petitioned NIH to grant licenses to other prospective producers of the enzyme replacement therapy because manufacturing problems at Genzyme, the exclusive licensee of patents held by Mount Sinai School of Medicine, had created severe supply problems.
When NIH refused to act, a larger group filed a class action lawsuit (pdf) in Pennsylvania federal court against Genzyme and Mt. Sinai for damages allegedly caused by their inability to get prescribed dosages of Fabrazyme®. As we reported last month, the suit raises novel legal theories and faces an uncertain future. (Earlier this month Genzyme filed a motion to dismiss (pdf) the lawsuit.)
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.
The Continuing Threat of Decreased Science Funding. At least for the moment, the two houses of Congress appear, finally, to be edging toward a budget compromise that would bridge the $51 billion gap between the House bill (which passed at the beginning of March) and the most recent Senate proposal. That’s a good thing, given that the current continuing resolution is set to expire on April 8.
Nevertheless, it seems increasingly clear that federal science funding is unlikely to increase from its fiscal year 2010 levels, and funding almost certainly will not meet the targets President Obama set in his FY 2012 budget proposal.
Back on January 18, 2010, we reported on the National Institutes of Health’s (NIH) refusal to exercise the government’s “march-in” rights under the Bayh-Dole Act with respect to the patent-protected drug Fabrazyme (agalsidase beta). The drug is an enzyme replacement produced from a recombinant mammalian cell line (i.e., a biologic) and is used to treat the symptoms of Fabry disease, a rare genetic condition that impairs the victim’s ability to metabolize fat and can lead to kidney failure and heart disease. Fabrazyme was developed at Mt. Sinai School of Medicine, which obtained two patents related to its manufacture and granted Genzyme an exclusive manufacturing license. After contamination at Genzyme’s facility led to a severe shortage and Fabrazyme rationing, a lawyer for three patients petitioned the NIH to march in and grant licenses to other manufacturers. As it has in all other cases, NIH denied the request.
Now, those same patients, joined by eight others, have sued Genzyme and Mt. Sinai (which the complaint erroneously describes as part of the public City University of New York, when in fact it is affiliated with the private New York University) over the shortage. The complaint (pdf) was filed on March 9, 2011 in the federal district court in Pittsburgh. The plaintiffs are represented by C. Allen Black, the same Pennsylvania patent lawyer who filed the NIH march-in petition.
In a few hours, the FDA will kick off a two-day public meeting to consider the future of clinical direct-to-consumer (DTC) genetic tests. Few corners of the personal genomics landscape have generated as much attention from regulators, consumers and, especially, the media as DTC genetic testing. Thus, when the meeting was first announced last month, we applauded the FDA’s attempt to examine DTC’s unique set of issues separate from other larger and ongoing regulatory conversations, including whether and how to regulate the far more numerous category of laboratory developed tests (LDTs).
So just what should we expect from the next two-days? 2010 saw a flurry of DTC-related regulatory and legislative activity but, ultimately, little in the way of new oversight or concrete guidance. Both regulators (including the FDA) and industry appear to have responded in 2011 with a more measured approach, and this week’s meeting is an opportunity to thoroughly examine the state of DTC genetic testing and develop a clear, sensible strategy for future oversight of the industry.
Over at Genetic Future, Daniel MacArthur has already weighed in, adopting a tone of cautious optimism in advance of the DTC meeting. Meanwhile, with just a few hours left until the meeting kicks off, here are three key points I’ll be emphasizing in my own talk tomorrow morning (slides):
We have recently summarized efforts by two state legislatures to design regulatory schemes addressing issues raised by the proliferation of genetic information about individuals. New York’s effort addresses questions of insurance coverage for genetic testing. Massachusetts’ goes much further, calling itself a “Genetic Bill of Rights,”a title that accurately reflects its ambitions. In reviewing both of these proposals we have made the point that state-level legislation is no substitute for a coordinated and long-overdue federal-level approach.
But who will lead that coordinated federal effort? As we wrote recently, since the 2008 publication of a SACGHS report identifying major gaps in the regulation of genetic testing, that committee has been disbanded and no clear successor has emerged to champion these issues at the federal level. Last week, the National Human Genome Research Institute (NHGRI), which was originally created by the NIH to support the Human Genome Project, and is today tasked with advancing the understanding and application of human genomics, updated its long-term strategic plan for the first time since 2003 (pdf). Although a “critical part” of the NHGRI’s mission is the “study of the ethical, legal and social implications (ELSI) of genome research,” the Institute’s new roadmap barely touches upon ELSI issues, and dispenses with “legal and public policy issues” in a single sentence by noting the need for “collaborations.”
[Editor's Note: This post originally appeared as a guest column at Xconomy.]
Last week, New York State assemblyman J. Gary Pretlow introduced the descriptively named “act to amend the insurance law, in relation to requiring coverage for genetic testing in accident and health insurance polices.”
While not accompanied by a press release, or widely covered by media outlets, the bill merits close attention. While the substance of the bill is striking, its greater import lies in what it reveals about the United States’ current framework for personalized medicine regulation and in what the bill portends for the future of personalized medicine innovation and investment in this country.
The Bayh-Dole Act was in the news at the end of 2010. Three patients suffering from Fabry disease, a rare genetic condition that impairs the victim’s ability to metabolize fat and can lead to kidney failure and heart disease, petitioned the National Institutes of Health (NIH) to exercise the government’s “march-in” rights under Bayh-Dole (pdf) and compel the holder of the patent on the only FDA-approved Fabry treatment to grant licenses to other manufacturers. Just as it has in response to every previous march-in petition, the NIH refused the march-in request (pdf).
Bayh-Dole, From the Beginning. Enacted in 1980, Bayh-Dole was intended to promote the commercialization of government-funded research by allowing universities and other non-profits that receive federal grants—rather than the government itself—to own any resulting patents. This then-radical change in the law gave rise to the practice of technology transfer, whereby universities conduct sponsored research, patent the results, and then license the use of the patented inventions to spin-offs (which often involve the faculty inventors as principals) and other private companies.
Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked:
1. Will the $1,000 genome live up to the hype?
2. Will personal genomics stay DTC?
3. How will the ongoing gene patent debate affect the progress of personalized medicine?
4. When and where will the next regulatory shoe fall?
5. Who will control the data?
A year later the question that comes first to mind is, has anything really changed?
The short answer is no, not fundamentally, although that is not meant to imply that nothing of note happened in 2010. Far from it, as significant legal, regulatory, policy and technological developments continued to reshape the personal genomics landscape.
With that in mind, we welcome 2011 with a look back at the year that was, and a look ahead at what to expect from 2011 and beyond.