FOR IMMEDIATE RELEASE: Monday, January 30, 2017
CONTACT: Sara Rabern (605) 773-3215
PIERRE, S.D. – On August 19, 2016, Attorney General Marty Jackley provided correspondence to the FDA and DEA urging both to assist in the determination of whether marijuana presents medical opportunities and further setting forth considerations for public health and safety.
“As Attorney General, I am hopeful for the sake of children and adults suffering medical conditions, that research will conclude derivatives of marijuana will help treat a child experiencing seizures or the pain of a cancer patient. If medical research reaches this milestone, I strongly believe that three important conditions must be satisfied for public health and safety reasons:
1. There needs to be FDA approval for marijuana or one or more of its derivatives
as a safe and effective drug;
2. A South Dakota doctor to prescribe the drug; and
3. A South Dakota pharmacist to dispense the drug,”
stated Attorney General Jackley.
On October 13, 2016, the DEA responded recognizing that:
While the DEA shares your desire to facilitate research with CBD, and to carry out any scheduling actions that are supported by the medical and scientific evidence, as you undoubtedly recognize, the protection of the public health and safety must remain of paramount consideration.
On January 26, 2017, the FDA responded that:
The U.S. Food and Drug Administration (FDA) shares your concern for children and adults suffering from diseases such as epilepsy and cancer, and is committed to advancing the development of new therapies. We agree that the drug approval process represents the best way to help ensure that any medicines derived from cannabidiol (CBD) or other constituents of marijuana are appropriately reviewed for safety and effectiveness, consistent with FDA’s statutory requirements….At present, FDA has approved several drugs for human use which contain active ingredients that are present, or similar to those present, in botanical marijuana….FDA has not, as of now, approved any drug containing marijuana or CBD as safe and effective for any therapeutic use. FDA is working diligently to support scientific studies that may determine the safety and effectiveness of these products….FDA encourages and supports medical research into the safety and effectiveness of marijuana products through adequate and well-controlled clinical trials conducted under an appropriate investigational new drug.
The Attorney General recognizes that there are several proposals being discussed this South Dakota Legislative Session surrounding medical marijuana and cannabidiol (CBD). As set forth above in the Attorney General’s August 19, 2016, letter to the FDA and DEA, the Attorney General strongly believes that there are three significant conditions that are very important for public health and safety reasons.
Attorney General Jackley’s Letter, FDA and DEA Responses