Updated: Mar 26, 2021
U.S. Food and Drug Administration (FDA) officials recently announced that Amy Abernethy, M.D., Ph.D., has resigned from her position with the agency. She served as the FDA’s principal deputy commissioner, acting chief information officer and CBD task force leader. An article in Hemp Industry Daily reported her resignation as “another setback” in the process for regulating CBD.
A change in leadership could lead to further delays
Abernethy has been the FDA’s principal deputy commissioner and acting chief information officer since February 2019. Her duties include overseeing the day-to-day functioning of the FDA, directing high-priority initiatives and overseeing the execution of the FDA’s data and technical vision.
She also currently leads the FDA’s CBD working group. This task force was reportedly formed in 2019 to address knowledge gaps surrounding CBD products, explore the ways CBD products could be lawfully marketed and determine the impact CBD products can have on public health.
As leader of the FDA’s CBD working group, Abernethy shared a few words at the opening of the FDA’s Nov. 2020 conference on cannabinoids and gender.
“We are committed to advancing hemp products with available regulatory pathways and we are further exploring what additional steps may be appropriate for hemp products, such as those containing CBD, to protect patients and public health, foster innovation for safe products and promote consumer confidence,” Abernethy reportedly said.
As hopeful as Abernethy’s comments were at this event, her decision to resign may lead to further FDA inaction with regards to CBD regulation. Throughout the hemp industry, FDA regulation of over-the-counter CBD products is generally considered overdue. So far, the agency has only approved one cannabis product, which is a prescription drug used to treat two severe forms of epilepsy.
The FDA did submit to the White House its Cannabidiol Enforcement Policy Draft Guidance for Industry. This was submitted in July 2020, over a year after the FDA renewed efforts to review cannabinoids. However, it was withdrawn early in 2021 after the newly seated Biden administration instructed all agencies to remove pending rules. It is unclear when the FDA intends to resubmit this guidance for approval.
A recent article in Hemp Industry Daily pointed out that this is also a critical time for the FDA because it is still dealing with the increased workload caused by the COVID-19 pandemic, and “President Joe Biden has not yet nominated a permanent FDA commissioner.” The article adds that “[s]ome cannabis industry analysts speculated that Abernethy was a strong candidate for consideration to lead the agency as commissioner.”
A ‘relentless advocate’ for improving the science behind FDA decisions
FDA Acting Commissioner Janet Woodcock released the news of Abernethy’s resignation in a March 23 memo.
She wrote, “I’m very sorry to see the FDA lose a talented and inspiring senior leader like Amy, but I take heart in Amy’s enduring accomplishments at the agency. Amy’s innovative spirit is renowned in the medical field and she has a unique understanding of how to harness new technologies for the benefit of patients and the public health.”
“Amy has been a relentless advocate for improving the science that informs FDA decision-making,” Woodcock added.
Abernethy is a hematologist, oncologist and palliative medicine physician who is recognized internationally as a clinical data expert and clinical researcher. Before joining the FDA, she worked as the chief medical officer, chief scientific officer and senior vice president for oncology at Flatiron Health.
She also spent time teaching as a professor of medicine at Duke University School of Medicine. During that time, she ran the Center for Learning Health Care in the Duke Clinical Research Institute and the Duke Cancer Care Research Program at the Duke Cancer Institute.
Abernethy looks to the future
Abernethy’s last day with the FDA will occur in mid to late April.
“We will use the next couple of weeks to ensure a deliberate, well-planned transition of Amy’s many responsibilities, including the PDC and CIO roles,” Woodcock wrote. “[Her] focus on FDA staff and on core operation excellence will ensure that Amy’s impact on the FDA remains long after she leaves the agency.”
Abernethy, herself, released a few comments regarding her job change.
“It has been an honor to serve as the FDA’s Principal Deputy Commissioner & Acting CIO,” Abernethy wrote in a March 24 LinkedIn post. “Over the last 2+ years, we developed the data & tech modernization plans, made progress in challenging areas like CBD, stood up the Evidence Accelerator, all while ensuring that we are advancing precision medicine in service of the patient.”
She did not explain her reason for the sudden change, but suggested that she is turning her attention to the future.
She wrote, “I leave the agency with humility, gratitude, and a continued commitment to uncovering solutions that will impact patients in the near and long-term. Onwards!”