Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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Up in Smoke
By Bob Pollock | April 29, 2016
Well, not really-but on April 12, 2016 (my birthday), the FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER) gave a presentation (here) entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.” It is quite interesting to note that FDA has been actively involved in the regulatory assessment of cannabinoid products for quite some time. For instance, FDA has approved two products, Marinol (dronabinol) in 1985 for nausea from chemotherapy and Cesamet (nabilone) (in 1985 and new indication in 2006) for nausea and neuropathic pain. There are currently generics approved for Marinol, but none yet for Cesamet.
The presentation outlines FDA’s goal to support the scientific development of products sourced from cannabinoids. As the virtues of marijuana are professed by the community, FDA also has a duty to assure that products placed into interstate commerce that claim to contain cannabinoids are properly regulated and that no false claims are made; thus, they have a strong enforcement posture relative to illegal products and products that make unsubstantiated claims, even if they profess to contain such ingredients and, in fact, don’t.
Scientific study continues and there are other new products in development, as well as some approved in Europe. The presentation indicates that there are 23 states that have recognized “medical marijuana,” 4 states (AK, CO, OR, and WA) and the District of Columbia that have approved the recreational use of marijuana, and 13 states recognizing cannabidiol for medical use.
Despite the relative easing of state laws, marijuana is still a Schedule I drug (with no recognized medical use) and is illegal from a federal statutory perspective.
There is lots of interest in the medical community, as well in the pharmaceutical industry. There are “high” expectations from many, but the “budding” scientists must deliver on the clinical goods before there is widespread planting of this method of treatment in the community. There are interesting things on the horizon, such as use in pediatric epilepsy, for cancer pain and spasticity, infantile spasms, and many other conditions.
）。相当有趣的是提到FDA在相当长的一段时间一直积极参与大麻产品的监管评估。例如，FDA已经批准两个产品，1985年批准Marinol（屈大麻酚）用于因化疗引起的恶心呕吐，和Cesamet（大麻隆）（1985年批准，2006年批准新适应症）用于恶心和神经性疼痛。目前Marinol已有仿制药获批，但Cesamet还没有。