RALEIGH – Just over a year after the original bill that legalized cannabis oil for treating intractable epilepsy became law, the General Assembly sent a bill to Gov. Pat McCrory expanding the legal ways patients can get hemp extract oil to control seizures.
House Bill 766 passed the Senate unanimously, and legalizes a hemp oil that contains no or very low concentrations of THC, the chemical that produces a “high” when marijuana is smoked.
One bill sponsor said that while last session’s bill was a good start, changes were sorely needed.
“The biggest feedback we got from parents who were in need of the medication was that access was still very, very limited,” said Susi Hamilton (D-Wilmington). “I am hopeful that this bill will go further in encouraging the research institutions to participate in the program. Most parents are still having to participate out of state.”
Supporters say this year’s bill provides a clearer and easier way for patients to provide the medication than current law, which limits the use to academic studies. Hamilton says she personally knows children who suffer from seizures, and that the experience can be frightening and debilitating.
“When children can’t develop because they’re constantly seizing, this can be a life-altering treatment for them,” she said.
While laws legalizing hemp oil have been passed in a number of states in recent years, some physicians have warned that not enough research has been done to know its true efficacy and side effects. And pharmaceutical research companies are not so sure about short-cutting the rigor of the approval process.
Stephen Schultz, vice president of investor relations for GW Pharmaceuticals, says that FDA approval is necessary to provide a high level of assurance.
“The FDA process yields a fully characterized medicine that is consistent batch after batch and manufactured to the highest quality standards,” said Schultz. “That rigorous process provides physicians and patients with the confidence in the medicine that is being prescribed to them.”
Beyond quality control, Schultz said the trials mandated for FDA approval improve the understanding of side effects and interactions with other medications patients may be taking.
Schultz had not seen House Bill 766. But he said GW Pharmaceuticals, which has an office and lab in Research Triangle Park, is researching cannabinoid medicines. The company says it is in Phase III drug trials that will wrap up late this year or early 2016, and that it will submit the drug for FDA approval in mid-2016. The company expects FDA approval to take 10 months, although a strict timeline is hard to predict.
Hamilton says the lack of FDA approval is outweighed by the critical need, and that the state should allow this treatment while the drug-approval process is ongoing.
“I think it’s legitimate that we follow other state’s leads and truncate that process,” Hamilton said. “The sooner you intervene, and the more success you have with that intervention, the more development the child will experience in that normal range, and they’ll keep up with their peers.”