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Posts in "Genomics"
September 12, 2014
Amid congressional wrangling this week over spending bills and pre-election posturing, a bipartisan group of House Energy and Commerce Committee lawmakers were busy examining options for improving the process for developing and regulating new medical technologies and treatments. The committee on Tuesday hosted a roundtable discussion (view video) with HHS Secretary Sylvia Burwell, top agency chiefs and leaders from several medical research organizations.
National Institutes of Health Director Francis Collins reminded lawmakers that the U.S. took the lead in mapping the human genome, which has led to new technologies. However, China now provides largest current investment in genomics research. Separately, Food and Drug Administration Commissioner Margaret Hamburg and researchers on the panel stressed the need for regulatory improvements to foster the development of personalized medicine, which uses genetic analysis to tailor medical treatments specifically to an individual patient.
September 11, 2014
Genetic testing advances have gotten ahead of federal regulators. That was a message delivered to lawmakers this week in a hearing on personalized laboratory-developed genetic tests. The tests examine genes and DNA to see if they indicate the presence of, or risk for developing, particular diseases or disorders, which can be used to develop treatment plans. A Government Accountability Office report in 2010 critiqued the quality of direct-to-consumer genetic tests and medical groups question the reliability of the information.
The Food and Drug Administration, which is tasked with regulating diagnostic testing, has held off focusing on the tests but has informed Congress that it will soon issue draft guidance regarding the oversight of laboratory-developed tests. However, while the agency is inching toward broader regulation, the process may take years.
CQ HealthBeat’s (@CQHealthTweet) Kerry Young reported on Wednesday on the varying testimony from cancer research groups who are urging stepped-up oversight of the tests and laboratory groups who question the authority and capability of the FDA to regulate testing. The FDA’s director of the Center for Devices and Radiological Health Jeffrey Shuren told the House panel that he will seek input on new regulations but noted, “whatever we come up with, we are not going to satisfy everyone.”
July 15, 2014
The House Energy and Commerce Committee, led by Rep. Fred Upton, R-Mich., over the past few months has been busy examining a range of topics to assist in the development of new legislation to overhaul federal health programs to foster the development of new technologies and medical breakthroughs. The committee is in the process of examining the development and approval process for new drugs and devices. The effort continues later this week with a hearing on leveraging communications technologies.