Colorado's consequences of the FDA-approved CBD drug will be different from most of the United States

The status of Schedule I marijuana at the Drug Enforcement Administration prohibits doctors from dispensing prescriptions for the plant or the drugs that result from it. Epidiolex, developed by a subsidiary of GW Pharmaceuticals, will still be illegal to prescribe through the DEA designation, but Colorado's decision to legalize medical and recreational marijuana, as well as some recent laws, will allow doctors to ignore this federal law and allow patients to use health insurance to pay for the drug as early as September.

Allowing medical marijuana and being one of nine states to legalize recreational marijuana was not enough protection for Colorado doctors to prescribe, forcing current MMJ physicians to "recommend" the plant to patients while banning pharmacies because it's not approved by the FDA. . Although receiving FDA approval is an essential step for Epidiolex, being made from marijuana always defies the rules of the DEA, so it will still be illegal to prescribe the drug until the status marijuana I be changed or abolished. To get around this hurdle, the Colorado General Assembly passed the HB 1187 in April to allow doctors to prescribe the drug for FDA approval, creating similar protections to those of synthetic THC drugs, such as Marinol.

According to Hoban Law Group lawyer Samantha Walsh, who lobbied for the bill and represents a number of CBD industry clients, Colorado's preemptive movement will allow its doctors to prescribe the drug while other states with legal pot will have to wait. "The 1187 passage lifted earlier prohibitions on pharmacists being able to issue marijuana-based drugs, but similar restrictions in other states must be taken on a case-by-case basis," she says, hoping that Other states will look at the measure as a model.

"I hope this will encourage regulators to focus on the rest of the page with industry and congressional will, and not just on CBD, but on full-spectrum hemp extracts as products." nutritional and well-being. there are prescription supplements and over-the-counter supplements, "she adds.

Although its legality is murky, CBD derived from hemp is available for sale online and throughout the country, with many CBD companies based in Colorado thanks to relatively favorable state laws for cultivation and cultivation. hemp processing. However, not all of these products are regulated, leaving the dosage and effectiveness of CBD products – some of which are used to treat severe cases of epilepsy, chronic pain, anxiety, and anxiety. 39 other ailments – no government supervision. Not all of these products will be regulated as Epidiolex arrives in Colorado, but Tim Gordon, president of the CBD functional solutions manufacturer, thinks there's more than enough room for the hemp industry- CBD to continue its rapid growth.

"This has been under preparation for a long time, it made sense to see these three swimming lanes," he says. "You now have leading cannabidiol products in the pharmaceutical pathway – Sativex, Marinol and now Epidiolex, and you have the natural products route with food and hemp supplements, and you also have the free-market way in the dispensaries.

Gordon says Epidiolex is essentially a tincture of CBD made for oral ingestion, and there are many counterparts available in the retail market. However, it is extracted from marijuana, not hemp, he explains. According to Gordon, most CBD extractors use whole plant infusion techniques and CBD isolates to make their products, while Epidiolex is obtained by refining the marijuana concentrate into a single molecule, which is eliminated from all THC. medication.

Although some members of the hemp industry have been concerned about allowing a pharmaceutical company to engage in CBD trading and draft special legislation to protect it, Gordon thinks the marijuana and hemp industries have no choice but to coexist with the pharmaceutical industry. "It's not a battle we were going to win, it's the creation of these swimming lanes," he adds. "While it's a thorn in my side that's Big Pharma, it's also a feather in my cap because it's cannabis."

Read the full FDA statement on the decision below:

"Over the past decade, we have seen a growing interest in the development of therapies derived from marijuana and its components:" medical marijuana "advocates have announced its use for many diseases such as cancer Multiple Sclerosis The FDA has been supporting research in this area for many years, but marijuana is an Annex I compound with known risks research to show that marijuana or its components could be safe and effective in the treatment of medical conditions should be kept at the same level as other drug compounds.And certainly it should not be held at a lower level, as some advocates suggest.The FDA has an active program to help drug developers who want to study marijuana or its components through well-controlled clinical trials, to demonstrate the potential of using safe and effective.

Today, the FDA has approved a purified form of the drug Cannabidiol (CBD). It's one of more than 80 active chemicals in marijuana. The new product has been approved to treat seizures associated with two serious and rare forms of epilepsy in patients two years of age and older.

The approval of this product demonstrates that the advancement of a solid scientific research to study the ingredients derived from marijuana can lead to important therapies. This new treatment offers new options for patients.

This is an important medical advance. But it is also important to note that this is not an endorsement of marijuana or any of its components. This is the approval of a specific CBD drug for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific disease. Moreover, it is a purified form of CBD. It is administered to patients in a reliable dosage form and by reproducible administration to ensure that patients derive the expected benefit. This is how medical science is advanced.

So today, in addition to celebrating this scientific achievement and the medical advancement it represents for these patients and their families, we should also reflect on the path that made this possible. This is a path that is available for other product developers who want to produce marijuana products through appropriate drug development programs.

This path includes a strong clinical development program, with careful consideration through the FDA's drug approval process. This is the most appropriate way to bring these treatments to patients. This process also includes a review of the purity of a new drug and manufacturing controls. Before a high quality drug can be developed, evaluated, and finally approved by the FDA; It is essential that the necessary work be done to identify drugs that are potentially beneficial to health and to carry out rigorous scientific research through adequate and well-controlled clinical trials. This is true for all drugs, including those derived from plant materials, such as marijuana. And the FDA remains committed to working with federal and state agencies, researchers, and product developers to advance this kind of important and conscientious work.

This research process – from early development to preclinical and clinical research – gives us a global understanding of a new drug. This includes understanding that the new product is safe and effective for treating a particular medical condition, what is the appropriate dosage and for which populations it is safe and effective, how the new compound might interact with other drugs, or if the new medicine has side effects or other safety concerns.

This work also helps product developers identify the appropriate dosage needed to achieve the desired therapeutic effect while minimizing toxicity and risk. Taken in full, the scientific evidence generated by these studies forms the basis of the FDA's benefit / risk assessment. And it is thanks to this painstaking, scientific and factual assessment of the FDA that healthcare providers can rely on a quality product that provides a uniform and uniform dose of an effective drug capable provide predictable treatment to patients. This is especially important when considering a treatment for a serious medical condition that will be used in the clinical care of patients who may have a number of health vulnerabilities. The purified form of CBD drug approved today by the FDA has been shown to meet these stringent standards.

Research on the therapeutic effects of marijuana and its components involves a number of federal agencies in addition to the FDA, including the National Institute on Drug Abuse, a part of the National Institutes of Health and the Drug Enforcement Administration.

The FDA has taken several specific steps to support this research.

We meet regularly with researchers to plan and carry out their tests. We have also formed a team of botanists who provide scientific expertise on botanical issues for researchers developing plant-derived drugs, such as marijuana. This team has published guidelines for the industry on clinical studies involving botanical drugs, as well as quality controls for batch-to-batch consistency. In recent years, the agency has also recommended to the DEA the approval of several hundred research protocol licenses for Schedule I for research on marijuana or its compounds.

In addition, the FDA is also working with companies to provide patients with access to experimental therapies as clinical trials are underway through expanded access provisions. These approaches help protect patients while enabling the collection of data necessary to support FDA approval of safe and effective therapies for use in the wider population. Through this process, hundreds of children have had access to experimental CBD products during the study of this product.

The drugs derived from marijuana are also eligible for several programs that aim to facilitate and accelerate the development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions . Much of the work we have done to encourage research in this area has led to the approval actions we have taken today.

The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific pathways. However, we remain concerned about the proliferation and illegal commercialization of unapproved CBD-containing products with unproven medical claims.

The promotion and use of these unapproved products may prevent some patients from accessing appropriate and recognized therapies to treat serious or life-threatening conditions. The FDA has recently taken action against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as drops of oil, capsules, syrups, teas and topical lotions and creams. These companies claimed that various CBD products could be used to treat or cure serious diseases such as cancer without any scientific evidence to support such claims. We will continue to act when we see the illegal marketing of products containing CBD with unproven medical claims. We are particularly concerned when these products are marketed for serious or life-threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other treatments whose benefits have been proven.

Today's approval demonstrates our commitment to the scientific process and collaboration with product developers to market marijuana products. We remain true to our standard of excellence in product development and overhaul. Such a process ensures that all new therapies for marijuana and its components are safe, effective and manufactured with consistently high quality. And most importantly, that these products have proven to be safe and effective for patients.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country's food supply, cosmetics, dietary supplements, products that emit electronic radiation and the regulation of tobacco products.