FDA Regulation about CBD and Cannabis Products: Epidiolex

FDA Regulation about CBD and Cannabis Products

2020 is an excellent year for the cannabis industry as the first FDA approved drug hits the market as a desheduled drug according to FDA and erasing Epidiolex aka CBD from the list of Controlled Substances according to the Controlled Substances Act (CSA).

But what is FDA Regulation about CBD and Cannabis Products: Epidiolex in 2020?

The DEA (US Drug Enforcement Administration) recently announced a descheduling cannabis-derived drug, Epidiolex, from the federal list of controlled substances.

GW Pharmaceuticals goes down in history as the first pharmaceutical to get approval to produce the over the counter drug. 

Understanding Epidiolex

Epidiolex is a drug manufactured to treat rare forms of epilepsy that affect many children.

It’s made of a pure form of CBD, which the company extracts from the marijuana plant.

Before the DEA’s announcement, Epidiolex was classified as a controlled substance in the US.

Thanks to its approval, it can now be sold at most pharmacies.

It was under the Schedule 5 Drugs of those medications that might be abused. 

Patients who use Epidiolex must have a prescription from the doctor, but there is no longer a limit on who the doctors are.

Previously, only those doctors under the DEA Drug Monitoring Program could prescribe this epilepsy medication.

The industry has taken this green light from both the FDA and DEA as a sign of what is to come.

The future seems bright, with the approval of more CBD products to follow. 

Much more needs to be done because most CBD products are yet to be approved by the FDA.

Even though in most states marijuana products are legal, weed is still illegal under federal law.

One reason Epidiolex got the approval is that it contains a high percentage of cannabidiol (CBD), which doesn’t cause a high.

THC is the one responsible for getting high, and it’s not present in Epidiolex. 

The Price of Epidiolex

After getting its FDA and DEA approval, GW Pharmaceuticals rolled it out across the country, recording massive sales.

In 2019, the company announced total global sales of $296 million, which is an impressive number in its launch year.

The company projects even better sales now that it has the go-ahead from the DEA, declassifying it as a restricted substance. 

Epidiolex is still an incredibly expensive drug, and a year of prescriptions can costs patients up to $32500 each.

GW Pharmaceuticals says the price is in line with what other epilepsy medications cost.

The good news is this drug is covered by medical insurance.

Even though insurance companies don’t cover drugs with CBD ingredients, the exception is Epidiolex.

This is fantastic because it is now an FDA approved drug to treat epilepsy. 

Using insurance to purchase this drug is significantly cheaper than buying over the counter with a prescription.

Estimates show that patients who have Medicaid can pay as low as $10 monthly for Epidiolex, which is a welcome relief to many.

Those that have private insurance may have to pay a higher price at $200 per month. 

It means that those that benefit the most from Epidiolex are patients that have medical insurance.

For those that don’t, the price is too steep. Many users still revert to using other CBD products like CBD-oil to treat seizures and other symptoms associated with epilepsy.

Still, many patients are leaning towards Epidiolex, seeing that it is approved by the FDA. 

FDA’s Role in Research on CBD and CBD Products for Medical Use

Every company that seeks to get a CBD product to be used for medical purposes must work with the FDA.

The FDA must be looped in all research regarding the product from start to finish.

To start, each researcher or company has to submit an IND application form to CDER (Centre for Drug Evaluation and Research).

This helps create a roadmap that the company must follow, which includes regular interaction with the FDA. 

In 2018, the Farm Bill came into effect and made it easier for researchers to study marijuana and all its potential uses.

These uses include medical ones. Many people are turning to medical marijuana to treat a wide range of illnesses.

This has necessitated more research and production of better quality products approved by the FDA. 

The process of conducting this research is not easy, as cannabis is still illegal under federal law.

The company has to interact with several agencies and adhere to set rules and regulations.

The FDA oversees its operations and ensures all clinical trial patients are safe and sound. 

This is giving a great image of FDA Regulation about CBD and Cannabis Products which is sure bright and soon will have more open space for better info of people to know more about CBD and its benefits.

The Bottom Line

The future seems bright for the cannabis industry with Epidiolex paving the way for more FDA approved drugs.

The process is long and tedious, but the results are worth it.

More research on the medical uses of marijuana is underway.

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