The U.S. Senate on Wednesday passed the 21st Century Cures Act, which includes $1 billion in new funding to prevent and treat opioid addiction. The House approved the measure last week.
The legislation includes funding for cancer research and mental health treatment, and will help the Food and Drug Administration speed up drug approvals. The measure also aims to improve the use of technology in medicine. The legislation passed 94 to 5, according to The New York Times.
Full story of prevention and treatment of opioid addiction bill at drugfree.org
The Food and Drug Administration (FDA) will determine whether naloxone devices distributed in communities should contain a standard dose of the opioid overdose antidote, according to U.S. News & World Report.
Drug companies that make naloxone devices do not agree on how much naloxone should be administered following an opioid overdose, the article notes. The outcome of a meeting this week between the FDA and naloxone makers could change the drug’s pricing and availability. The average price of naloxone has risen from $1 a dose a decade ago to $40 a dose today.
Full story of FDA on naxolone devices and standard doses at drugfree.org
If a tobacco company changes a label for a product, the Food and Drug Administration (FDA) cannot consider it a new product for regulatory purposes, a federal judge ruled this week.
U.S. District Judge Amit Mehta said changing the quantity of a product in packaging does make it a new tobacco product, and requires FDA approval, according to the Winton-Salem Journal.
The three biggest tobacco manufacturers, Altria, Lorillard and Reynolds-American, sued the FDA and the Department of Health and Human Services in 2015 over new packaging rules.
Full story of tobacco label change at drugfree.org
The Food and Drug Administration (FDA) has approved Probuphine, an implant that contains the opioid addiction treatment buprenorphine. The drug has been available in oral form for 14 years, CNBC reports.
Probuphine consists of four small stick-like implants that are inserted in the upper arm, during a doctor’s visit that typically lasts less than 15 minutes. The implant remains in the arm for six months, and is removed by the doctor, the article notes. It will be available only by prescription.
The implants are designed to provide a constant, low-level dose of buprenorphine in patients who are already stable on low-to-moderate doses of other forms of buprenorphine. Probuphine is designed to be part of a complete treatment program, according to the FDA.
Full story of buprenorphine for opioid addiction treatment at drugfree.org
The Food and Drug Administration (FDA) on Thursday announced it is extending its oversight to all tobacco products, including e-cigarettes, Reuters reports. The agency will ban sales of e-cigarettes, cigars, pipe tobacco and hookah tobacco to people under age 18.
Companies will be required to submit all tobacco products to the FDA for regulatory review. They will have to provide the agency with a list of product ingredients and place health warnings on their product packages and in ads.
The move allows the agency “to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide,” the FDA said in a statement.
Full story of FDA extending oversight on tobacco and e-cigarettes at drugfree.org