In 2015 and 2016, ASHG submitted comments to the U.S. Food and Drug Administration (FDA) on two related proposed regulations for Next Generation Sequencing (NGS)-based in vitro diagnostics. Appreciative of being engaged in the process, ASHG submitted comments to further inform and clarify the issue. Related: Comments on “Use of Standards in FDA Regulatory Oversight... Read More
ASHG supports state licensure of certified genetic counselors to help ensure that the public has access to genetic and genomic services provided by qualified health professionals. The rapidly expanding use of genomics in healthcare decisions will increase the need for qualified genetics professionals, and genetic counselors play an important role in treating patients and families.... Read More
S. 2744, the Genetic Research Privacy Protection Act, was introduced in the Senate in 2016. This bill, supported by ASHG, would guard against the inappropriate use of the Freedom of Information Act to gain access to research participants’ genetic information, and would build on existing privacy protections by strengthening Certificates of Confidentiality. Its provisions were... Read More
H.R.1313, the Preserving Employee Wellness Programs Act, a 2017 bill, would fundamentally undermine privacy provisions of the Genetic Information Nondiscrimination Act (GINA) and the Americans with Disabilities Act (ADA). Related: Group Letter to House Leaders Opposing H.R. 1313 (March 2017) Letter to House Leaders Opposing H.R. 1313 (March 2017) Press Release: ASHG Opposes H.R. 1313,... Read More
In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs). With a focus on genetic and genomic testing, ASHG submitted comments on the proposed regulatory oversight of such tests. Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight... Read More