Amit Bhagwandass is a rising third-year student at University of North Carolina School of Law.
New rules adopted by the Federal Communications Commission (FCC) have an appreciable impact on the way that hospitals, nursing homes and other inpatient and outpatient health care providers will monitor their patients in the future. The new FCC rules enable the use of Medical Body Area Networks (MBANs). MBANs are low-power wideband networks consisting of multiple body-worn sensors that transmit various patient data to a control device that collects data from the sensors.
Wireless devices operating on the MBAN spectrum can be used to continuously monitor a patient’s health by measuring indicators such as blood glucose levels, blood pressure and electrocardiogram results. Additionally, wireless health devices can include mobile devices and associated applications of increasing relevance to consumer health and personalized medicine, such as mobile-device enabled sensors that monitor vital signs for any number of traits or conditions like blood pressure, glucose levels or even the early signs of an asthma attack.
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.
Earlier this month an FDA advisory panel met for two days to consider a range of issues pertaining to clinical direct-to-consumer (DTC) genetic testing. The non-voting advisory panel’s discussion (pdf), including whether certain genetic tests or categories of tests should be made available only through qualified healthcare professionals, sparked considerable controversy (see here for a collection of links) and confusion.
In response, the FDA agreed to reopen the public docket in order to receive additional public input on scientific issues concerning DTC genetic tests. The docket will reopen tomorrow and will remain open through May 2nd (pdf).
For those with an interest in the FDA’s oversight of DTC genetic testing, this is the first of several opportunities to be heard. In addition to the newly reopened public docket, the FDA has also announced its next “town hall discussion” with top officials from the Center for Devices and Radiological Health (CDRH), the FDA center responsible for the regulation of medical devices, including genetic tests. Both CDRH director Jeffrey Shuren and OIVD Director Alberto Gutierrez are scheduled to participate in a public question-and-answer session on May 5th in Orlando, FL. An additional town hall discussion is slated for San Francisco, CA later in the year. The Genomics Law Report will post additional details for that meeting as they are made available.
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.
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.
Earlier today, the U.S. Food and Drug Administration (FDA) announced that it will hold a public meeting July 19-20 to “discuss how the agency will oversee laboratory-developed tests (LDTs).” The FDA has made several high-profile announcements over the past month – particularly in the area of direct-to-consumer (DTC) genetic testing – but today’s development, despite its not receiving the same degree of media attention, is likely the most significant development to date.
Why? Until today, the FDA’s recent announcements have involved a series of letters to DTC genetic testing companies, beginning last month with Pathway Genomics and continuing last week with letters to five other prominent DTC companies. Despite all of the attention paid to these letters, the sum total of the FDA’s regulatory focus amounted to only a handful of products. Today’s announcement, on the other hand, declares the FDA’s intent to much more aggressively regulate the entire field of LDTs. While an exact count of the number of LDTs available is impossible, GeneTests.org lists more than 2,000 genetic tests from nearly 600 laboratories, numbers which do not even include genetic tests and other diagnostic products offered DTC. After having been criticized for a policy of case-by-case regulation, the FDA has answered with a move to regulate the entire field of laboratory-based testing.
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Nearly a month ago we reported that the House of Representatives Committee on Energy and Commerce had launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to several of the most prominent DTC companies: 23andMe, Pathway Genomics and Navigenics.
Today the Committee has followed up with another letter, this one directed to 23andMe president and co-founder Anne Wojcicki, inquiring into the circumstances surrounding the company’s recent and widely reported sample swap. The letter (pdf), which is signed by the same four Representatives (Waxman, Barton, Stupak and Burgess) requests the following:
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The FDA has published online letters sent to five personal genomics companies – 23andMe, Navigenics, deCODE Genetics, Knome and Illumina – informing the companies that they are manufacturing and selling medical devices without appropriate FDA premarket review and approval. No surprise that the news that the FDA has sent out letters to some of the most well-known providers of DTC genetic testing products is already making waves. (Daniel MacArthur was the first to point me to the AP story, and Mary Carmichael of Newsweek and Andrew Pollack of The New York Times were among the first to dive into the substance of the letters.)
Below, we will discuss the immediate and long-term implications of the FDA’s most recent regulatory actions for the five companies receiving letters, as well as for the DTC genetic testing industry. First, however, a review of the letters themselves is required. Each of the five two-page letters is signed by Alberto Gutierrez, Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), and follows a similar format throughout. To gauge the impact of these letters we will take them paragraph by paragraph.
Andrew Pollack of The New York Times reports that, in an interview, OIVD Director Alberto Gutierrez indicated that the saliva collection kit Pathway had planned to sell through Walgreens may be a clearer case of a DTC genetic test subject to FDA oversight. According to Director Gutierrez, “Once you take a collection device and you are marketing through a drugstore, it is very easy for me to say whether something would fall under our policy.”
Well that was quick. On Tuesday, Pathway Genomics and Walgreens announced a partnership to sell a saliva collection kit for Pathway Genomics’ direct-to-consumer (DTC) genetic tests in Walgreens’ thousands of drugstores nationwide. Less than forty-eight hours later, after the FDA repeatedly voiced its concerns about the arrangement, Walgreens has hit the brakes.
According to an MSNBC story, the FDA sent a letter to Pathway “asking the test maker to show it has regulatory approval, or prove why [the test] should be sold without the agency’s blessing.” In response, Walgreens is “elect[ing] not to move forward with offering the Pathway product to our customers until we have further clarity on this matter.”
Back to the Drawing Board. Despite its obvious significance, it is hard to be surprised by this latest development. When the Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) tells The Washington Post that you would be selling an “illegally marketed device” if you proceed as intended, you should know the letter is already in the mail and retreat to the drawing board as quickly as possible.