The US Senate has approved the Comprehensive Addiction and Recovery Act (CARA), a bill that would authorize $181 million in new spending to combat the nation’s opioid and heroin abuse crisis. The vote was 92-to-2. The bill now goes before President Obama, who is expected to sign the legislation. Among the important parts of the bill is a provision that would allow certain nurse practitioners and physicians assistants to administer buprenorphine, an opioid addiction medication, to patients. Current federal law only permits doctors to do so and only 100 patients at a time. The White House’s proposed budget for fiscal year 2017 calls for $1.1 billion to combat drug addiction. And just last week, Democrats in Congress tried to add $920 million in new funding to CARA, but were thwarted by Republicans. Posted July 13, 2016. Via USA Today.
Allowing terminally ill patients the right to try experimental medicines not yet approved by the FDA has been adopted by the Republican Party platform committee. Currently, 31 states have so-called “right to try laws” and similar legislation has been introduced in 18 other states. “We commend those states that have passed Right to Try legislation, allowing terminally ill patients the right to try investigational medicines not yet approved by the FDA. We urge Congress to pass similar legislation, giving all Americans with terminal illnesses the right to try,” the amendment to the platform states. Right now, if terminally ill patients can’t get access to an experimental drug through a clinical trial, federal law allows them to petition the FDA to get the drug through “compassionate use.” The agency typically approves most of these requests, though drug makers must also give the green light. Posted July 12, 2016. Via STAT.
Cheaper versions of expensive biologic medications took a step closer to reality after an FDA advisory committee recommended approval of copycat versions of 2 biologics used to treat arthritis. The FDA’s Arthritis Advisory Committee voted unanimously that the agency should approve Sandoz’s biosimilar of Amgen’s Enbrel (etanercept). The same group also unanimously recommended approval of Amgen’s biosimilar of Abbvie’s Humira (adalimumab). Enbrel is indicated for rheumatoid arthritis, psoriatric arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and plaque psoriasis, while Humira is indicated for rheumatoid and psoriatric arthritis, plaque psoriasis, Crohn’s Disease and ulcerative colitis. Treatment with biologic medicines typically costs tens of thousands of dollars annually, but approval of the 2 biosimilars would cut the cost significantly. Enbrel brought in more than $5 billion in U.S. sales last year, while Humira generated $8 billion. Posted July 13, 2016. Via Reuters.