Almost 70 percent of those products had different amounts of CBD than were specified on the product label, with many testing positive for the psychotropic THC even though the products are legally not supposed to have any THC.
Earlier this year, an FDA advisory panel unanimously recommended that the FDA approve Epidiolex, in large part due to strong research data and evidence of the drug's effectiveness in controlling the violent drop seizures that accompany two rare forms of childhood epilepsy. The FDA granted landmark Federal approval to a marijuana-derived drug to treat pediatric epilepsy. While CBD has purely medicinal purposes, the other compound, tetrahydrocannabinol (THC), is what gives marijuana users the psychoactive effects commonly associated with the plant. The pharmaceutical manufacturer behind the drug, GW Pharmaceuticals, is negotiating prices with health insurance companies.
That means that - just as with any other drug - as long as pharmaceutical companies can demonstrate they've subjected a marijuana-derived candidate to large, well-designed clinical trials, it has a fair chance of being seriously considered for approval by the FDA. The agency is expected to do so within 90 days. The FDA has approved the first medication containing marijuana for patients with rare forms of epilepsy.
"There is some research that indicates that CBD specifically could interact with other medications such as statins, and increases the amount of those medications in the blood", Chadi said. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care.More news: Apple releases iOS 12 Public Beta
Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use.
A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program.
He added, "This is how sound medical science is advanced".
The medication needs to go through several more steps before it's available as a prescription.More news: Furious Maradona wants meeting with Argentina squad
In clinical trials, children with Dravet syndrome who took Epidiolex experienced 39 percent fewer seizures; those with Lennox-Gastaut syndrome saw a 37 percent decrease.
First, the FDA must confer with the Drug Enforcement Administration to decide when to "reschedule" cannabidiol, better known as CBD, Devinsky said.
As a result, Epidiolex's launch remains at the discretion of the DEA, which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, so as to allow GW to begin selling it. ABC News also confirmed this expected timeline with Christy Curran, spokesperson for GW Pharmaceuticals.
For years, families of children with severe seizure issues have been turning to marijuana-based substances to find relief from debilitating episodes, often skirting the law to obtain what they said was their only effective treatment option.More news: Meghan Markle stuns at event with husband Prince Harry and The Queen