The FDA issued new guidelines to speed up the review process for gene therapies; a new report calculates the potential societal benefits of eliminating the opioid epidemic; and one-third of Americans are unaware that the ACA's open enrollment season has begun.
New guidelines will speed up the FDA’s review of gene therapies to get these treatments to market faster. The agency will still require clinical trials, but the process will be faster for these novel therapies, reported The New York Times. In addition, the FDA said it will increase oversight of clinics offering dangerous or unproven versions of treatments involving human cells and tissues. Unregulated procedures have been offered to treat arthritic knees, back pain, heart disease, and other problems.Preventing opioid overdoses, deaths, and substance-use disorders could have saved $95 billion in 2016, according to a new report. The research brief from Altarum calculated the societal benefits of eliminating the epidemic based on productivity gains from saving lives and reducing substance use, averting healthcare costs, and reducing spending on other services that help address the opioid epidemic. In 2016, deaths related to opioids, heroin, fentanyl, and related drugs reached more than 53,000.Nearly one-third of all people are that open enrollment for the Affordable Care Act has begun. Kaiser Health News reported that, despite the high number of people unaware of the enrollment dates, which includes one-third of uninsured people, open enrollment is off to a strong start. So far, 1.5 million people have enrolled through HealthCare.gov. The shorter enrollment season, which is just 45 days this year, may be pushing people to sign up earlier.