A New Policy Platform for ASHG

Posted by: Derek Scholes, PhD, ASHG Director of Science Policy

We are delighted to announce that ASHG has a new policy platform! Developed with the help of members and approved by the Board of Directors, the platform articulates where ASHG stands on a variety of policy issues – which issues are of key importance and our positions on those issues. It will provide direction for the Society’s policy and advocacy activities, and will be essential for communicating our policy perspectives to lawmakers and other stakeholders.

The platform covers four different policy categories that collectively capture the broad scope of ASHG’s policy interests. They are the conduct of genetics research, genetics in healthcare practice, societal uses of genetics, and the teaching of genetics and genetic literacy. Within each of these categories are highlighted a number of key issues, together with relevant statements that the Society has published. We define key issues as those that are consistent with our mission and where we can have an influential role.

Altogether, 17 key issues are listed. Of course, it will not be possible to address all of these at the same time. Rather, we’ll focus our energies according to the evolving policy environment and the prevailing needs of members. For example, in the past month, we’ve partnered with other societies within the Federation of American Societies for Experimental Biology to advocate for increased funding for biomedical research on Capitol Hill, especially timely given proposed cuts to NIH funding by the Trump Administration. We have also been drumming up opposition to the Preserving Employee Wellness Programs Act (H.R.1313), a bill introduced last month that would fundamentally undermine important provisions in the Genetic Information Nondiscrimination Act. Plus, we’ve been speaking out about the potential impact of proposed new travel restrictions to the U.S. on the international scientific community and the research enterprise.

In order to be successful in any of these advocacy activities, we need your help! To facilitate this, we have created a new Take Action page. Currently, you can visit the page to sign on to a letter opposing H.R.1313 and also let us know how the proposed immigration restrictions are impacting you. We’ll keep you updated as we continue to develop this.

Derek Scholes, PhD, is ASHG’s Director of Science Policy. For questions regarding ASHG’s policy and advocacy activities, email policy@ashg.org.

ASHG Policy and Advocacy: 2017 Highlights

Posted By: Derek Scholes, ASHG Director of Science Policy, and Jillian Galloway, Science Policy Analyst

As the year comes to an end, we thought it timely to reflect upon the Society’s many policy and advocacy accomplishments in 2017.

First, with the help of members and approval by the Board, we established a new policy platform. It will provide direction for ASHG’s policy and advocacy activities for the next several years. This is essential for communicating our perspectives to lawmakers and other stakeholders.

Early in the year, we took action to preserve the genetic privacy protections outlined by the Genetic Information Nondiscrimination Act (GINA). As strong supporters of GINA, we opposed the Preserving Employee Wellness Programs Act (H.R. 1313), a bill allowing employers to ask employees invasive questions about their and their families’ health, including genetic tests they may have undergone. We also encouraged members to contact their legislators and sign on to the ASHG opposition letter. More than 1,000 of you did so and it had a real impact: Our opposition to H.R. 1313 was widely reported in the media and since then, the bill has not moved forward in Congress.

In addition, ASHG supported a $2 billion increase in funding for the National Institutes of Health (NIH). We have seen a $2 billion increase in the NIH budget for 2018 and we ask that Congress continue the progress we have made. As we all know, we need robust, predictable, and sustainable federal funding to fuel scientific advances. Currently, federal agencies are operating under a “continuing resolution” (CR) set to expire December 22. With the deadline fast approaching, Congress needs to pass another CR to keep the government running into the new year.

20171219_FASEBHillDay
ASHG, along with representatives from other FASEB societies, participated in FASEB’s Hill Day this spring. (Credit: Dr. Scholes)

More recently, we opposed any changes to the tax-exempt status of tuition waivers within the U.S. Congress tax bill called The Tax Cuts and Jobs Act (HR 1), as proposed by the House (but not the Senate). The House provision changed the tax-exemption status of tuition waivers commonly granted to graduate students, and taxing them would create financial hardship for individuals with already modest incomes. Thanks to the efforts of concerned members and other scientists, the final version of the tax bill does not include such a provision.

Also, this year the Society released a position statement on germline genome editing. This statement is the latest in a series that the Society issues periodically on a range of genetics policy issues and uses of genetic information. Written by a workgroup led by Kelly Ormond and Doug Mortlock, and including perspectives and feedback from members, the statement gives the Society’s perspective on the use of CRISPR/Cas9 or similar tools to alter the genome of an embryo or germ cell.

To help you learn more, share current policy information, and contact legislators directly, we also launched a new Advocacy Center. This site makes it easy for members to take action by sending customizable messages to Congress on important science policy issues, as well as learn when ASHG is speaking out and how to get involved. It links to ASHG statements, blogs, and press releases on pending genetics policy issues.

ASHG is working hard to keep you informed and empower you to influence science policy. In the new year, it will take all of us becoming engaged to build on the Society’s advocacy progress in 2017.

Derek Scholes, PhD, is Director of Science Policy at ASHG, and Jillian E. Galloway, MS, is a Science Policy Analyst at ASHG. Learn more about ASHG’s activities in Policy & Advocacy. and share your thoughts on policy issues or ASHG’s efforts by emailing policy@ashg.org.

Just Launched: A New Advocacy Center for ASHG

Posted By: Jillian E. Galloway, Science Policy Analyst at ASHG

We are delighted to announce that ASHG has a new online Advocacy Center! Developed with members’ needs in mind and the Society’s desire to become more involved in policy and advocacy, the site provides tools and channels for members to learn more and share their views directly with legislators.20171013_advocacy-center

The Advocacy Center makes it easy for members to take action by sending customizable messages to Congress on important science policy issues. Members and others can also stay current with press releases and news clips related to ASHG advocacy activities, read recent letters and comments to policymakers, explore blog posts related to policy and advocacy, and check out helpful tools and resources.

ASHG advocates for policies consistent with its policy platform that support scientific discovery, the translation of scientific discoveries into health advances, and the appropriate application of genetics within society. We further support policies that advance the understanding of genetics by healthcare professionals and the public.

To reach these goals, we need your help! Visit our Advocacy Center to connect with Capitol Hill and get your voice heard on a number of significant issues, including supporting NIH funding and opposing genetic discrimination!

Jillian E. Galloway, MS, is a Science Policy Analyst at ASHG. Learn more about ASHG’s activities in Policy & Advocacy.  

FDA Takes Steps to Advance Genomics Technology, Encourage NGS-based Test Innovation

Guest Post: Laura M. Koontz, PhD, U.S. Food and Drug Administration 

20180504_FDA-Koontz
Laura M. Koontz, PhD, U.S. Food and Drug Administration (courtesy Dr. Koontz)

Genomics is advancing at an unprecedented pace, a fact that will come as no surprise to members of ASHG who work on the front lines of this exciting field. Over the past few years, the FDA has been working with stakeholders from across the genomics community, including ASHG, with the goal of applying our regulatory authorities to genomics in ways that encourage innovation and ensure that tests provide accurate and meaningful results to patients. Recently, we announced two new FDA Guidances on next generation sequencing (NGS)-based in vitro diagnostics that are intended to encourage further development of these powerful tests and enable more efficient regulatory review by FDA.

The first guidance, “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics,” describes an approach where test developers may rely on clinical evidence from FDA-recognized public databases to support clinical claims for their tests and provide assurance of the accurate clinical evaluation of genomic test results. Using FDA-recognized databases will provide test developers with an efficient path for marketing clearance or approval of a new test. Further, FDA believes that this guidance will encourage crowdsourcing of NGS evidence generation, curation, and data sharing, advancing the development of high quality precision medicine treatments and diagnostics.

The second guidance, “Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)–Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases,” discusses FDA’s considerations for analytical validation of NGS-based tests intended to help diagnose suspected germline diseases. The Agency believes the analytical validation recommendations laid out in this guidance could spur the creation of consensus standards for NGS-based tests that will be developed by the community and potentially recognized by FDA. Moreover, the guidance articulates FDA’s belief that NGS tests for germline diseases could potentially be classified in class II (moderate risk)  based on conformance to the recommendations in this guidance or to standards that address these recommendations, which would allow FDA to consider exempting them from premarket review.

The Agency believes these guidances will provide test developers with a more efficient path to market, improving FDA’s ability to protect public health by ensuring these tests provide accurate and meaningful results, while at the same time speeding patient access to NGS assays by lowering barriers to innovation. And importantly, the guidances will help to give patients, payers, researchers, and clinicians greater confidence that NGS platforms can reliably be used to inform critical treatment decisions and improve patient outcomes.

To learn more about these two guidances, please join the FDA for a webinar on Thursday, May 24, from 2:00-3:30 p.m. U.S. Eastern Time.

Laura Koontz, PhD, is a member of the Personalized Medicine Staff in the Center for Devices and Radiological Health at the U.S. Food and Drug Administration. She has a PhD in Molecular Biology and Genetics and was the 2012-2013 ASHG-NHGRI Genetics & Public Policy Fellow.