The U.S. Food and Drug Administration (FDA) recently took steps to streamline its operations, which is designed to give the agency a methodology for quicker response to regulatory action about a food or drug and could become a major benefit for their future work in cannabis.
In 2014, The Program Alignment Group, made up of senior FDA officials, was charged with identifying and developing plans to modify FDA’s functions, processes, and structure in order to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that are regulated, and new legal authorities.
In 2016, the resulting action plans to modify FDA’s functions and processes in six different areas – biological products, bioresearch monitoring, human and animal foods, medical devices, pharmaceuticals, and tobacco – were set in motion.
Cannabis researchers hoping to work with the FDA are encouraged by this alignment action, noting that, when the agency considers any regulatory work on cannabis, it would have to investigate, test and approve the cannabis plant compound by compound – 400 by some estimates – in a long process that could take up to ten years. Anything that can speed up the process is an undeniable benefit toward regulation and the eventual advancement of the industry.
The alignment came about because of a real concern that the agency couldn’t keep up with its mission of inspecting, testing and regulating on a timely basis.
As manufacturing and production operations in all of the FDA-regulated entities around the country became increasingly complex, FDA leaders recognized the need to try and have a field force specialized in the same way that the people at the FDA headquarters were specialized.
For example, with this alignment, people on the drug side who are reviewing drug applications, or approving drug applications, or creating adverse event reports, or issuing warning letters about compliance actions, are the same people who only deal with drug products. They would not also deal with food products.
And, according to a source close to the FDA, this alignment will be the first time that FDA has had a programmatic specialization for bioresearch monitoring, a relatively new field with rapid technological advances.
The good news is that this streamlining, or alignment, may soon become a benefit for the cannabis industry when the agency gets around to diving deeper into the kind of federally-approved lab testing many legislators look to when researching medical marijuana.
Experts have said that when the FDA gets more involved in the approval of any product containing or derived from botanical marijuana for research and regulation – some say that it has already taken symbolic steps with the approval of similar but synthetic cannabis products – this streamlining will create a more rapid rollout of regulations.
For the cannabis industry, this new alignment model is good news though it may not appear that way at first.
The fact that more and more clinical research is being done with medical marijuana and extracts, along with the fact that FDA will now have a dedicated cadre of specialized bioresearch monitoring investigators, means that there could be more FDA inspections and enforcement in this space, according to the FDA source. That doesn’t appear to be a positive outcome.
If that were to happen, it might look like FDA is suddenly paying more attention or cracking down on medical marijuana research.
But according to the FDA source, it’s just a reflection of increased research in the industry and greater inspectional expertise by the FDA investigators, which could enable the FDA to find issues that might be overlooked by less experienced investigators.