Maintaining Regulatory Compliance When Manufacturing
Twenty-three years ago, California became the first state to legalize medical marijuana. Today, 33 states (plus Washington D.C.) have legalized medical marijuana, while 11 of these states have legalized recreational marijuana as well. Certain states only permit cannabis to be marketed in some sort of therapeutic form, like oils or pills, while others prohibit the sale of cannabis except through state-licensed dispensaries.
But while it’s all but impossible to take a cross-country trip these days without passing through more than a few states that have legalized cannabis, this versatile substance remains unequivocally illegal at the federal level. This raises a unique dilemma for pharmaceutical companies: is it possible to maintain regulatory compliance with federal laws and FDA regulations while meeting consumer demand for cannabis-infused products? In other words, can these companies seek FDA approval for cannabis-derived drugs without running afoul of federal laws and regulations?
Learn more about the FDA approval process for cannabis and cannabis-derived drugs, as well as the important role compliance and quality control specialists play in the process.
Seeking FDA Approval of Cannabis and Cannabis-Derived Drugs
As of mid-2018, there were three cannabinoid-based medications boasting FDA approval. Meanwhile, there are currently more than 100 cannabinoid clinical trials being conducted in anticipation of certain federal regulations being rolled back. With a proposal to remove cannabis from the federal list of Schedule I controlled substances, pharmaceutical companies that are already working on cannabinoid medications will be that much closer to FDA approval once the federal restrictions on cannabinoids are relaxed.
The pharmaceutical companies planning to enter the medical marijuana (MMJ) market in the near future are hoping that the clinical data they’re generating will help change perceptions (and clear up some misconceptions) in the healthcare industry. Many physicians who practice in states with legalized MMJ remain reluctant to prescribe or recommend cannabis to their patients because of the lack of longitudinal data on its effects.
Because so few cannabis-containing products are FDA-approved, the FDA doesn’t receive much (if any) information about negative side effects—and even when this information is passed along, it can be all but impossible for the FDA to determine the dosage and ingredient list of the product that caused someone problems. By expanding the list of FDA-approved cannabis products, the FDA hopes to standardize cannabis dosages and maintain an open line of communication with doctors, patients, and pharmacists to help monitor side effects.
Currently, federal guidelines prohibit an entity (including a hospital or pharmaceutical company) from promoting a drug that is not yet FDA-approved. Pharmaceutical companies also can’t promote an FDA-approved drug for off-label uses. But physicians are legally permitted to prescribe or recommend a non-FDA-approved therapy, and an increase in cannabis demand in the states that have legalized it could eliminate the need for much pharmaceutical marketing.
The Importance of Compliance in Cannabis Manufacturing
Researchers seeking approval of a new cannabis drug are required to submit an IND application to the federal Center for Drug Evaluation and Research (CDER). This application process puts the FDA on notice that a new cannabis drug is being developed and tested, creating a mutually-beneficial partnership that allows the FDA to maintain a 10,000-foot view of the process while encouraging the pharmaceutical company to set certain drug-development benchmarks.
In 2018, the Farm Bill removed hemp from the list of controlled substances under the federal Controlled Substances Act. Hemp, which contains cannabidiol (CBD), is one of the most heavily-researched forms of cannabis, and its removal from the CSA list can speed up FDA approval by largely excising the DEA and other federal drug-interdiction agencies from the review process.
But regardless of whether you’re studying (and hoping to market) THC-containing cannabis, hemp nutraceuticals, or federally-legal CBD, it’s crucial to educate yourself on your company’s compliance responsibilities to avoid running afoul of the FDA’s many rules and regulations. Failing to adhere to these regulations could indefinitely delay FDA approval of a company’s product, even if it has the potential to help millions.
For many companies, hiring a compliance consultant who has specific experience in cannabis compliance can be money well-spent. These consultants are incredibly familiar with FDA cannabis regulations and can ensure that your marketing materials don’t make any claims that violate these regulations (like using the words “treat,” “diagnose,” “prevent,” or “cure”) or fail to include all relevant product ingredients. Unless you’re already well-versed in cannabis regulations, this usually isn’t an area you’ll want to DIY, as these regulations can be tough to digest.