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.
The current budgets and proposed funding changes, as set forth in a recent AAAS report on federal R&D (see pages 40 and 42), are as follows:
|Current FY ‘10||House FY ‘11||Senate FY ‘11||White House Request
for FY ‘12
|NIH||$3.12 billion||5.2% cut
to $29.5 billion
|No change||2.4% increase
to $31.8 billion
|NSF||$6.9 billion||5.8% cut
to $6.6 billion
|No change||13% increase
to $7.8 billion
While overall science funding looks to be in for a rough year, other innovation-boosting legislation appears to be gaining support, at least in the Senate. The Small Business Innovation Research (SBIR) program requires 11 federal agencies with large outside research budgets to award at least 2.5% of this spending to small businesses. The Senate’s bi-partisan SBIR/STTR Reauthorization Act would extend the set-to-expire SBIR program through 2019 and increase the percentage devoted to the program by federal agencies to 3.5% by 2023. This bill would also open the program to small-businesses that are majority-owned by venture capital firms, which were previously excluded because they aren’t independently owned.
This would particularly benefit small biotechnology companies, as many more biotech start-ups rely on venture capital funding than software start-ups (pdf). The Senate bill would allow the NIH and the NSF to award 25% of their SBIR funds to venture-owned small businesses. Not surprisingly, the Biotechnology Industry Organization supports the proposal.
However, even if the Senate is able to pass the SBIR reauthorization bill, there is no guarantee that the House will follow, particularly when it comes to opening up SBIR grants to VC-owned small businesses.
DTC Developments. Despite considerable commercial and regulatory uncertainty, the direct-to-consumer (DTC) genetic testing continues to attract new businesses, at least abroad. Australian-based Lumigenix, which launched its first DTC product earlier this year, was profiled this past week by GenomeWeb. Daniel MacArthur and Michael Müller also drew attention to a new (and pricey) DTC offering from Indian company Avesthagen. In Germany, meanwhile, there is at least one new and satisfied 23andMe customer despite recent German legislation that, at least on its face, appears to ban DTC genetic testing entirely. This is a helpful reminder that legislation—even proscription—is only as effective as its enforcement.
Finally, back in the United States, the debate over how to properly regulate DTC genetic tests is set to continue with the FDA announcing this week that it is reopening the docket from last month’s DTC meeting for additional public comment. With that discussion certain to continue for the foreseeable future it was encouraging, therefore, to see the NHGRI highlight regulation of genetic testing, including DTC genetic testing, as one of its new ELSI (Ethical, Legal and Social Implications) research priorities, even if the NHGRI may find it difficult to supply adequate funding for that research (see above).
Medical Technology Caucus. In a new development that could increase the lobbying power of medical device developers and other personalized medicine companies, Senator Scott Brown (R-MA) has joined forces with Senator Amy Klobuchar (D-MN) to form the bipartisan Senate Medical Technology Caucus.
Both Massachusetts and Minnesota have large medical technology industries and the move has been applauded by industry representatives, including the Medical Device Manufacturers Association. The corresponding House Caucus was formed in 1993 and is chaired by Eric Paulsen (R-MN) and Anna Eshoo (D-CA).
Roundup of tweets from the intersection of genomics, personalized medicine and the law:
- GLR Post: The FDA and DTC: Time to Set the Record Straight: http://bit.ly/fWJBg4 #FDADTC
- #FDADTC docket reopens tomorrow, until 5/2: http://bit.ly/i80OKs Chance to set the record straight: http://bit.ly/f9lWgq
- RT @drjonboyg: Newborn screening programs need better consent rules, experts say http://j.mp/eGfdZm
- The impact of human gene patents on genetic testing in the United Kingdom: http://bit.ly/hBHxui from GiM, HT @eurogene
- RT @pgx_reporter: Q&A: Cancer Commons’ Tenenbaum on Building a Patient-Centric System for Personalized Oncology: http://bit.ly/hvqz8K
- Germany’s strict genetic testing law (http://bit.ly/gXMgkg) didn’t stop this @23andMe customer: http://bit.ly/f0zqdE
- More on SBIR/STTR reauthorization progress in Senate, from @gw_dailyscan: http://bit.ly/fawftu
- RT @bachinsky: DARPA Puts Out Call for a DNA-Embedded Genetic Surveillance Machine http://t.co/C6gijo1
- Interesting profile/update by @Xconomy of patent aggregator/licensor Intellectual Ventures: http://bit.ly/erJBLo
- Taming the dragon: genomic biomarkers to individualize the treatment of cancer http://bit.ly/fNDPzE in Nature Med HT @FierceBiotech
- Good to see NHGRI articulate detailed ELSI research priorities/targets: http://1.usa.gov/fYuiGL Better had it come w/ news of add’l $$$
- Petition: “Congress: Don’t Cut Life-saving Funding for the National Institutes of Health”: http://bit.ly/gw30ST >14K signatures so far.
- MT @JohnCFierce: FDA insider allegedly made $119K on Somaxon insomnia drug approval. At least somebody made $$ on it. http://reut.rs/g6OMHN
- Avesthagen DTC product apparently 1.8M SNPs for 45K Rupees (=~$1K). PR focuses soley on disease. No PGx, carrier screening or ancestry incl?
- RT @dgmacarthur: Personal genomics hits India, via local biotech Avesthagen: http://bit.ly/gzeRgK (via @nutrigenomics) More on this soon…
- FDA chemist charged by SEC with insider trading: http://on.wsj.com/h16lBY via WSJ
- RT @GENbio: Legal Challenges to Healthcare Reform Threaten Biopharmaceutical Legislation http://bit.ly/fT16bt
- MT @daphnezohar: Startupamerica @ MIT FDA session takeaways: reduce duplication of failure by cos (use FDA knowledge), increase transparency
- RT @dgmacarthur: Christine Patch and Barbara Prainsack have their considered take on the #FDADTC meeting at BioNews: http://bit.ly/hggIVk
- RT @ldtimmerman: Cambridge, MA’s Epizyme, riding high on 2 pharma deals, zeroes in on personalized cancer therapy. http://bit.ly/g4Vy6H
- GLR Post: Frustrated by NIH Inaction, Fabry Patients Attempt End Run Around Bayh-Dole: http://bit.ly/hUmGwe
- RT @GenCounsNews: Advanced degree options for genetic counselors being explored by @NSGC_Org taskforce http://bit.ly/efjdAV
- RT @JCainHart: Interesting & timely given some recent similar situations in RTP. “Academic bias & biotech failures” | http://bit.ly/esYQ1D
- RT @matthewherper: Why are there so few biotech billionaires? http://ow.ly/4nW55
- RT @wilbanks: When you share data, you make it more valuable. Here comes the science. http://hdl.handle.net/2027.42/78307
- Update on SBIR reauthorization: http://bit.ly/gyubGx VC’s pushing for access. Another house/senate stalemate looming? cc @JCainHart
- Interesting reading: Humana’s coverage policies for genetic testing (http://bit.ly/iav6X1). No surprise: DTC, WGS generally excluded.
- Been on market since at least Jan. RT @GenomeWeb_News: Australia’s Lumigenix Launches DTC Genomics Offering: http://bit.ly/hQyO4p
- (For those actually using twitter, if you have suggestions for how to improve the GLR’s Twitter Roundup please let me know)
- Twitter Roundup: #FDADTC Edition (& a new format): http://bit.ly/dXQ592 Incl. @genomesunzipped/CC0, patent reform & more
- Friday already? RT @genomesunzipped: ‘Disguised’ heritability, mktg personal genomics, deciphering dev. disorders http://bit.ly/eRHTTl
- RT @InheritedHealth: Genzyme hit with more Fabrazyme drug woes http://ow.ly/4lUVx
- Interesting paper in GiM re: “medical & graduate students’ attitudes towards personal genomics” http://bit.ly/gVuHqp
- Thought RNAi litigation was done after last week’s settlement (http://bit.ly/dRjafg)? Think again: http://bit.ly/gvM5m9
- RT @S_O_NYC Signups for #sonyc are near room limit—if you’re coming, sign up now so we can book a larger room. http://bit.ly/hsNU6q
- RT @daphnezohar: .@ldtimmerman asks VCs: “Are you toast?” and reports that Canaan is still doing ok http://bit.ly/fH7nqi
- RT @GenomeWeb_News: Celera Sued Over Plans to Sell to Quest: http://bit.ly/gg11Bb
- RT @GenomeWeb_News: Bill Seeks to Restore Minnesota Genomics Partnership Funding: http://bit.ly/fWaKHS
- Watch @anderson_carl of @genomesunzipped niftily double my UC risk (but reassure me not to lose any sleep over it): http://bit.ly/dYfwnw