The twin express trains of federal and state cannabis policy have been on a collision course for decades. At an unprecedented and well attended FDA meeting on Friday, the conductors stoked the engines.
The gathering was billed as “Scientific Data and Information about Products Containing Cannabis and Cannabis-Derived Compounds.” In attendance were representatives from academia, health care, manufacturing, retail, distribution and, of course, the consuming public.
New FDA Commissioner, Ned Sharpless, opened the meeting with a reminder of the approval pathways available to food and drug manufacturers:
- Food Additive Pathway – A substance that is not naturally occurring in a food cannot be added unless it is Generally Regarded as Safe (GRAS) by qualified experts. Evidence in support of safety for a food additive can be submitted to the FDA, which, if it finds the data supports the request, can approve the additive.
- Dietary Supplement Pathway – A dietary supplement may be cleared by the FDA if sufficient evidence and data are submitted to support its safety. Unproven health claims are not permitted on Dietary Supplement labels.
- Drug Approval Pathway – A drug can be cleared by the FDA when enough evidence in support of safety and efficacy are established through clinical trials or by demonstrating equivalence with another marketed drug.
Additionally, Sharpless pointed out that because CBD is the active ingredient in GWPH’s Epidiolex, the dietary supplement pathway is not available to products containing that substance. We should note that dietary supplements, like fish oil, can become the active ingredient in a subsequently approved drug, but not the other way around. The FDA does have the authority to alter this approach by regulation but Commissioner Sharpless called that “new terrain.”
Over 100 speakers presented including GW Pharmaceuticals (GWPH). Based on questions asked by FDA panelists and scientific evidence presented, the major themes with which the FDA will wrestle in the coming months and years are:
Broad Agreement on Potential Beneficial Effects – Testimony largely supported the widely held belief that cannabis and cannabis-derived products could be determined beneficial if more research is conducted.
Need for More Research – The evidence presented was mixed and often contradictory. In addition to a dearth of scientific evidence on the safety and efficacy of a wide range of cannabis and cannabis-derived products, there is also a demonstrated need to study mode of delivery, dosing, impact on vulnerable populations like the elderly and pregnant women, the cumulative effects of routine use, and drug-drug interactions. Despite the requirements of the 2018 Farm Bill, there were several complaints about permit approval process at the DEA and the quality of samples provided by the University of Mississippi, the DEA’s contracted grower.
Product Integrity Concerns– Evidence submitted by academic researchers and consultants suggest that the product labels frequently do not provide accurate information on the amount of CBD and THC in a product. They also found products that were adulterated with other substances like dextromethorphan. There was broad agreement that the industry must be subject to Current Good Manufacturing Process regulation as soon as possible. One witness suggested the industry was on a “race to the bottom” due to lax practices and false claims.
Preferred Approval Pathway – There appeared to be some consensus that cannabis and cannabis-derived products use the dietary supplement pathway, which contradicts FDA Commissioner Sharpless’ introductory comments.
However, testimony from trade groups suggested that CBD derived from hemp could be safely added as a dietary supplement. GWPH seemed to support a similar idea by suggesting that cannabis or cannabis-derived products that do not require medical supervision should be available to the mass market. Notably, that proposal made its way into a tweet by Dr. Amy Abernathy, the FDA’s point person on cannabis policy.
Urgency – Given the proliferation of state laws decriminalizing and legalizing, in one form or another, cannabis and cannabis-derived products, the absence of scientific evidence and the lack of manufacturing and labeling controls, the need for regulation is acute, according to the witnesses.
WHERE DO WE GO FROM HERE?
The FDA is likely headed toward approval of the use of cannabis and/or cannabis-derived products as a dietary supplement at some concentration they feel is safe enough for mass market consumption and does not run afoul of statutory prohibitions.
To accomplish that task, the FDA will need more research and data on what might constitute safe levels of cannabis and cannabis-derived products. Former FDA Commissioner Scott Gottlieb appeared on CNBC on Friday and suggested that the onus is on industry, specifically calling out packaged consumer product manufacturers as putting pressure on regulators despite lacking the necessary safety data.
The FDA will also need to find a way to overcome the prohibition of allowing FDA-approved drugs, which require medical supervision, to be added to a dietary supplement. The active ingredient in GWPH’s Epidiolex is, of course, CBD. Under currently law, CBD cannot be marketed or sold as a dietary supplement.
The FDA’s options, then, are limited. They could approve a cannabis or cannabis-derived product that does not contain CBD, assuming data on safety could be developed. Witnesses suggested certain hemp products might find this a viable pathway.
The final determined pathway for approval of cannabis and cannabis-derived products is material to the pharmaceutical industry and especially GWPH. Testimony from the National Epilepsy Foundation indicated that patients unable to afford Epidiolex are turning to unregulated CBD. Other witnesses, in response to FDA panelist questions, suggested the freely available CBD could deter research on pharmaceutical applications.
The timing of next steps is unknown but the FDA has previously indicated that they could have a first draft of a regulatory framework - not actual regulation - available later this summer, which appears optimistic in our view. On an aggressive timeline, regulation could be proposed late 2019 or early 2020 which could produce final regulations by late 2020 or early 2021. Depending on the state of the scientific evidence, product approvals may not occur until 2021.
In the meantime, the FDA is getting pressure to enforce current law and regulation, aggravating the conflicts between state and federal jurisdictions.
Of course, Congress could always act. There are a number of bills pending in Congress but none address the issues raised at Friday's meeting. The STATES Act would defer to state-level regulation of cannabis while the SAFE Act would give cannabis-related businesses access to banking services. Neither bill, plus a plethora of efforts dedicated to use of cannabis at the VA have moved very far this year. Only the SAFE Act has secured a committee vote and awaits another before going to the House Floor. The Senate appears committed to indifference on the matter at this point.
How and when the next steps are taken will depend on a variety of factors. Cannabis growers, manufacturers, retailers and distributors are going to have to develop a more sophisticated approach in making their case to the FDA. As the FDA Commissioner noted, the plural of anecdote is not data. The consumer product companies that Dr. Gottlieb indicated are pressuring regulators also need to step into the light. None made presentations and their apparent preference for hiding behind cottage industry participants will not serve them well, in our experience. Finally, it is important to remember that the best funded and best staffed area of the FDA is dedicated to drug approvals. For that reason, there has and will continue to be an institutional bias in favor of pharmaceutical companies like GWPH, especially when they come armed with scientific data derived from randomized clinical trials.
Call with questions. We are in uncharted territory so you must have some.
Emily Evans
Managing Director – Health Policy
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