Attorney General Jackley Addresses Research and Development for Medical Marijuana Derivatives with the FDA and DEA
PIERRE, S.D. – Attorney General Marty Jackley continues to work with the FDA and DEA to address research and development for medical marijuana and its derivatives.
“As Attorney General, I am hopeful that research will conclude marijuana derivatives will help treat a child experiencing seizures or the pain of a cancer patient. I am urging the FDA and DEA to consider accelerated research of marijuana for treatment purposes. If marijuana is determined to provide a medical benefit, I believe safeguards for public health and safety can be put in place which include FDA approval, a South Dakota doctor prescribing the drug, and a South Dakota pharmacist dispensing the drug,” said Attorney General Jackley.
On August 19, 2016, Attorney General Jackley provided correspondence to the DEA and FDA urging consideration of an accelerated research and development process for marijuana derivatives. While Attorney General Jackley made clear he was not endorsing a particular area of research or marijuana use, he believes that the public health aspect justifies both the DEA and the FDA revisiting the research restrictions as it relates to marijuana with an eye towards medical research in a controlled environment.
The DEA response on October 13, 2016, outlined several steps that have been taken to address the FDA approval process including with Cannabidiol (CBD). The DEA set forth 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.”
Attorney General Jackley agrees and believes three important conditions must be satisfied for public health and safety reasons: 1) FDA approval for marijuana or one or more of the 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.
In December 2015, the DEA adopted a new policy to waive certain regulatory requirements to those who are conducting research with CBD to include those conducting trials with CBD no longer have to request approval from the DEA before implementing changes to their research protocols.
In August 2016, the DEA adopted a new policy whereby additional entities may apply to become registered to grow marijuana for the purpose of supplying researchers. In addition, the DEA continues to assess the current regulatory requirements for conducting research with CBD to determine whether it can take further steps to reduce the regulatory burden while continuing to protect the public health and safety.
The DEA recognizes the possibility that drugs containing CBD might be proven to be safe and effective for the treatment of certain conditions and with FDA approval for marketing. The DEA closed the correspondence with their assurance they will strive to make it easier for research while keeping the public safe.
Links to letters below: