How Does a Synthetic Medical Marijuana Drug Get Approved By the FDA?

Marinol is an FDA approved medication that is a synthetic THC. It is available in oral form to combat nausea from chemotherapy and also helps stimulate appetite in AIDS patients. The debate between oral Marinol and smoking marijuana for these issues is substantial. The purpose of this article is to provide an overview of the FDA approval process.

In the US, the Food and Drug Administration decides if a drug is safe for human consumption in the marketplace. How does it get there? A clinical trial is conducted and is typically sponsored by the drug sponsor.

Most of the time, that sponsor is a large pharmaceutical company. Some people tend to snub their noses at these companies, but it takes deep pockets to fund modern clinical trials. Plenty of ground breaking medications come out of clinical trials, including chemotherapy breakthroughs and less vital drugs such as Viagra.

The National Institute of Health also funds commercial development of drugs for severe diseases such as AIDS, Cancer, epilepsy, and Multiple Sclerosis. It was through one of these programs that Marinol was invented and studied.

Before a drug ends up in human testing, it is often tested in animals. Animal rights groups do not like this one bit, but it is reality. If you had a loved one dying of cancer, you might think differently about a life extending medication that had its origin being studied in mice originally. When animals are studied, this is the preclinical drug phase.

Let’s say a researcher is investigating appetite in mice. He or she may do this by inducing a disease state in mice that decreases appetite. Then the mice are either given the investigational drug or whatever is considered the “Gold Standard” for increasing appetite. If the investigational drug works in the study, the drug maker submits and Investigational New Drug application to the FDA. The FDA then has a month to either contest the IND, and if not the drug maker may start testing in human beings.

There are typically 3 phases in clinical trials. In Phase 1 the drug is given to healthy volunteers to make sure it is safe and to determine dosing. Phase 2 then is almost like a Pilot Study with patients who have the condition intended for treatment receiving the medication. Safety and side effects are watched. Phase 3 involves a large group of patients confirming efficacy.

How long does all this take? On average, an unbelievable 5 years. If it is a complicated experimental drug, it may take longer. Also, if the condition is rare, it may take a while to enroll enough patients.

How many drugs make it through? About one in five drugs that start the process secure FDA approval. Considering the cost of all 3 phases runs anywhere from $200 million to $600 million, these trials are very risky.

After Phase 3, a New Drug Application is submitted to the FDA for marketing approval. It then takes an average of 1.25 years for the FDA to complete its review. Since 1992 when the FDA was allowed to charge fees it has allowed more staffing and the time for review has dropped from 2 years to 15 months.

The FDA then approves the drug for a specific indication. If the drug maker wants to add an additional indication, there is another application process. Marinol is the only marijuana based prescription medicine available in the US. Marinol moved from Investigational New Drug status to approval in only two years, much less than average.

That initial approval was for nausea and vomiting associated with cancer chemotherapy in 1985. In 1992, the drug maker applied and received FDA approval for AIDS wasting.