Drugs

Reschedule Marijuana to Schedule 3: FDA

FDA has recommended to the Drug Enforcement Administration that marijuana be rescheduled from a Schedule 1 drug to a Schedule 3 drug under the Controlled Substances Act. Attorneys at Keller and Heckman write in a National Law Review post that the final decision ultimately will rest with DEA.

The attorneys explain that Schedule 1 drugs have a high potential for abuse, have no currently accepted medical use (CAMU), and there is a lack of accepted safety for their use under medical supervision. They say that Schedule 3 drugs have a lesser potential for abuse, have a CAMU, and their abuse may lead to moderate or low physical dependence or high psychological dependence.

In its justification, FDA indicated that while marijuana is the most frequently abused federal illicit drug, “it does not produce serious outcomes compared to drugs in Schedules 1 or 2.” The agency also said there is widespread experience with the medical use of marijuana by licensed healthcare providers operating under state-authorized programs and that there was “some credible scientific support” for using it to treat anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy-induced nausea and vomiting, pain, and post-traumatic stress disorder.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome