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FDA Extends LDT Comment Period
On August 19, the Food and Drug Administration (FDA) announced that it has extended the deadline to submit comments in response to its plan to regulate laboratory-developed tests (LDTs) from August 15 to September 15. LDTs refer to tests developed in-house by laboratories and marketed as a clinical laboratory service. Comments may address patient considerations, laboratory challenges, direct-to-consumer marketing of testing, and education and outreach.
Access the notification in the Federal Register
Schwarzenegger Spearheads "Telehealth" System
On Wednesday, August 18, Governor Schwarzenegger and the United States Chief Technology Officer Aneesh Chopra announced the launch of the California Telehealth Network (CTN), the nation's largest telehealth center, which intends to connect hundreds of patients, hospitals, and providers electronically. At the announcement of the program, Governor Schwarzenegger said, "Through a simple broadband link, this state-of-the-art system will save lives by instantly connecting people from across the state, including underserved and rural areas, with the best and brightest doctors. The California Telehealth Network marks the beginning of a new digital highway that will fundamentally change the future of how health care is provided."
While this is the largest telehealth network, it is unlikely to be the last. As stated in the press release, CTN is a public and private, federal and state partnership that can be used as a model across the nation as states strive to fund and establish other networks.
Read or watch the Governor's entire speech
Stem Cell Policy Fails to Hold Up In Court
On Monday, August 23, a federal judge ruled against President Obama's 2009 executive order expanding embryonic stem cell research, citing that the policy violated a ban on federal money to be used for the destruction of embryos. Many scientists are unsure as to how this ruling will impact their work. The National Institutes of Health (NIH) advised researchers to continue their research, having already received the funds for it,; however, 22 projects that were supposed to get their funds in September are currently at a halt. An appeal by the federal government to this law is expected soon.
Read the text of the Ruling
Biden Talks Recovery Act and Genomics
On Tuesday, August 24, Vice President Biden held a press conference to unveil a new report describing how the American Recovery and Reinvestment Act of 2009 (ARRA) will lead to breakthroughs in several critical areas. Congress passed the ARRA on February 13, 2009. The bill was signed into law by President Obama four days later.
Among the successes Vice President Biden touted included increased funding to support innovations for biomedical advancements. The ARRA bill gave a total of $10 billion for the NIH, including $8.2 billion for scientific research, which includes supporting the sequencing of more than 1,800 genomes. NIH director Francis Collins said, referring to ARRA funding, "The Recovery Act funding is not only producing thousands of jobs in the biomedical research community, it is also helping speed important medical discoveries that will benefit the health of Americans nationwide."
Watch Biden's press conference
Discover more about ARRA and its impact
Healthcare Reform: Clinical Trials
Genetic Alliance is dedicated to providing information on how the Patient Protection and Affordable Care Act affects the genetics community. There is no question that clinical trial participation is vital to advancing the development of crucial treatments and therapies. Clinical trials can also be a means by which patients, if eligible, can access new treatments. However, patients often encounter difficulties in obtaining coverage or reimbursement for the treatments they receive as part of participating in a clinical trial. In 2014, the Patient Protection and Affordable Care Act will require insurance companies to cover costs for those they insure that participate in phase I through IV of clinical trials.
Read more about this part of the law