Is the 21st Century Cures Act Bad for Your Health?

Texas will receive more than $27 million to fight the opioid epidemic when the first funds are released from the 21st Century Cures Act. The announcement came April 19, five months after the law was signed by President Barack Obama.The Cures Act continues to spark intense disagreement among patient advocacy groups, doctors and scientists. Some say the law jeopardizes patient safety as it aims to speed up the process of discovery and drug approval.Opponents also argue that the law gives too much leeway to drug companies seeking approval for new uses of existing drugs. And some say the entire drug and medical device approval process needs to be streamlined.The law promised $5 billion to boost former Vice President Joe Biden’s “cancer moonshot” initiative that aims to double the speed of cancer research; $1 billion in state grants to fight the opioid epidemic; and almost $5 billion for the National Institutes of Health.The act's reforms in mental health care, such as suicide-prevention programs, are based on the Mental Health and Safe Communities Act co-sponsored by U.S. Sen. John Cornyn, R-Texas.But some health-care programs will take financial hits, and certain agencies could be stripped of their regulatory powers. The act cuts $3.5 billion from an Affordable Care Act prevention fund, which combats hospital-associated infections and dementia. The Food and Drug Administration, which oversees the safety of medicines and medical devices, will lose some of its authority, experts say.The end of clinical trials?Under the Cures Act, medicines could be approved more quickly and without the rigorous testing they currently undergo, said Dr. Giuseppe Giaccone, associate director for clinical research at Georgetown University.“It’s pretty bad for the FDA and very bad for patients, but it’s good for drug companies,” he said. “They’ll have more freedom to do whatever they like.”The law allows the FDA to approve new uses for medicines based on “real world" evidence — the kind provided by patients using the medication in a real-world setting as opposed to carefully designed and controlled trials. That means the use of clinical trials — the gold standard for testing a drug’s efficacy and safety — could fall.  Continue reading...