In the pharmaceutical industry, regulatory compliance issues governing the development and marketing of drugs are formidable. For Greenwich Biosciences—the US subsidiary of UK-based GW Pharmaceuticals, the company that’s developing medications derived from components of the marijuana (or cannabis) plant—the challenges are twice as difficult.
Marijuana is still classified by the US Drug Enforcement Administration (DEA) as a Schedule 1 controlled substance, or simply, a drug that is currently without accepted medical use in the United States. But GW Pharmaceuticals is conducting promising clinical trials for prescription cannabinoid medicines that, if successful, will result in the DEA’s reclassification of a specific cannabinoid, or cannabidiol (CBD). The company expects to submit a New Drug Application to the US Food and Drug Administration (FDA) in mid-2017 for Epidiolex, a liquid formulation of CBD used to treat rare childhood-onset epilepsy disorders.
If the application is accepted, Epidiolex will be the first plant-derived cannabinoid to obtain FDA approval and be moved to a less restrictive position on the schedule of controlled substances.
GW is the first company in the world to test cannabis-derived medicines with “a scientifically responsible approach,” says Angelique Lee-Rowley, the company’s US general counsel and compliance officer. Having started her career as a scientist for a medical device company, Lee-Rowley has the credibility to make that judgment and to navigate between science and law. Her background is ideally suited for helping the company in its preparation to commercialize novel medicines in the United States.
Of course, developing drugs from a substance that the US government puts in the same class as heroin presents legal challenges and a perception problem. Though marijuana has been legalized in some states for medical and/or recreational purposes, the federal government has not followed suit.
As a result, the burgeoning marijuana industry is in a legal limbo, and it is still not officially accepted by the medical profession.
“We’re constantly having to differentiate the company from the medical marijuana community,” she says. “We’ve had vendors refuse to work with us because their policies don’t allow them to work with medical marijuana companies.”
This complicates efforts to reach contractual agreements. The company must get the word out that it is going through the same rigorous scientific and clinical processes to develop drugs as every other pharmaceutical company. This same rigorous approach cannot be said for medical marijuana, which from a medical perspective, is loosely regulated at best as herbal remedies. While medical marijuana appears to aid some people, the lack of regulation means there are no guarantees of consistency in quality and dosage, as Lee-Rowley points out. And not being subjected to the rigors of controlled clinical trials means that the impact of marijuana on patients hasn’t been fully explored.
“We’ve had vendors refuse to work with us because their policies don’t allow them to work with medical marijuana companies.”
“We are finding that, similar to other pharmaceuticals, there are real side effects—interactions with other epilepsy drugs, for instance,” Lee-Rowley says, adding that these should be closely monitored by a physician.
From a compliance standpoint, this means GW Pharmaceuticals and Greenwich Biosciences have to fully disclose such effects on patients. There have been cases in recent years where pharmaceutical companies have avoided such responsibilities with tragic results.
“The pharmaceutical industry has been under intense scrutiny for its conduct, including putting patients’ lives in danger to promote and sell products,” Lee-Rowley says. “When you work for a company that is pioneering drugs derived from a controversial substance, it’s crucial to uphold the highest standards of integrity.”
Her professional motto, “keep the patient in mind first, and compliance will follow,” guides Lee-Rowley’s approach. As she and the UK-based head of legal affairs hone compliance policy, they are aiming to have personal integrity permeate all areas of the business. Instead of a culture where anything that is not expressly prohibited in writing is fair game, leaders in the company want everyone to take responsibility for compliance and maintaining high ethical standards. Lee-Rowley has witnessed firsthand what can happen when a culture plays fast and loose with compliance. She was the compliance director with Siemens Healthcare Diagnostics, a subsidiary of the German conglomerate Siemens AG, when the latter was embroiled in a bribery and corruption scandal. As top managers investigated the roots of the problem, they discovered a pervasive culture that tolerated corruption, Lee-Rowley says. Company policies were insufficient to combat this atmosphere.
It took years of concerted effort, including extensive training, strong leadership, and new policies to change the culture. Lee-Rowley’s role included developing training programs, customizing corporate policy for US laws and regulations, assessing risk of distributors and business partners, and investigating employee conduct. This work has since become evidently transformative.
“Siemens now has a gold standard compliance culture,” Lee-Rowley says.
Though the scandal and its aftermath was a blow to Siemens, it was a rich learning opportunity for Lee-Rowley. “It was a phenomenal experience to go through as a lawyer,” Lee-Rowley recalls.
Her work during this time yielded bona fides in compliance, which resulted in opportunities to speak at conferences focused on compliance issues.
It was also ideal practice for her current task of helping a young pharmaceutical company ramp up staff to market and distribute new products. Lee-Rowley and other members of company leadership are implementing the foundation for ethical and legal behavior by marketers and salespeople.
She is now working with government affairs specialists to pave the way for marijuana-derived drugs. About 750 patients have been using Epidiolex free of charge under the FDA-authorized Expanded Access Program that permits the use of investigational drugs to the most needy patients on a compassionate use basis.
In states that have legalized marijuana, Greenwich Biosciences has the responsibility of getting the message out to lawmakers that those state laws do not apply to its products, and additional steps must be taken to ensure that patients will have access to its product through pharmacies.
Lee-Rowley and Alice Mead, fellow lawyer and vice president of government affairs, coordinate with a public affairs staff working at the state level to ensure that lawmakers are aware of this important distinction.
GW Pharmaceuticals has other cannabis-derived drugs in the pipeline, including cannabidivarin (CBDV) that shows clinical promise in other forms of epilepsy, as well as autism. There is also Sativex, a drug approved in forty countries outside of the United States for the treatment of MS spasticity. GW Pharmaceuticals recently released its first results in oncology as well, with a study focusing on glioma.
Tapping into her inner scientist, Lee-Rowley looks forward to tracking the progress of drug development through the stages of clinical trials. While she doesn’t long to work with microscopes and test tubes, she enjoys poring through the data. This is where her science background is particularly advantageous, allowing her to scrutinize whether public statements on the drugs are truly supported by the research.
Because lawyers, scientists, and marketers have to achieve consensus on how to promote products, being able to see data through multiple lenses is a highly desirable trait for a general counsel in the pharmaceutical industry. In 2018, GW Pharmaceuticals expects to have an answer from the FDA on its new drug application and the DEA on its new schedule. If all goes well, shortly afterward Greenwich Biosciences, the company’s US subsidiary and exclusive distributor, will likely go to market in the United States. Then, the framework that Lee-Rowley and other leaders are implementing will get its first big test. With her legal background, backed by science acumen, the odds of a positive result are improved.
Katten Muchin Rosenman LLP:
It is a pleasure working with Angelique. Her deep knowledge of the industry and quick understanding of complicated legal issues have been tremendous assets when working with Greenwich Biosciences.
—Bruce G. Vanyo, Partner