FDA veteran Dr. Teresa Buracchio will temporarily take the helm of FDA’s neuroscience division upon the retirement of longtime head Billy Dunn, who notably oversaw the agency’s controversial approval of the Alzheimer’s treatment Aduhelm.
Background: Buracchio spent most of her career steeped in neuroscience, and notably finished a neurology residency during medical school and a separate geriatric neurology fellowship. After a brief stint in neuroscience clinical development at AbbVie, she joined the FDA in 2013 as a medical officer, first in the gastroenterology division before moving over to neurology, where she worked on drugs in disease areas including Alzheimer’s, dementia and epilepsy.
Buracchio rose through the ranks to oversee the agency’s division of neurology 1, where she has played a leading role in several of the regulator’s recent drug approval decisions, including its debate over an experimental ALS drug from Amylyx Pharmaceuticals.
“We continue to keep in mind the context that ALS is a rare, devastating disease with enormous unmet medical needs,” Buracchio said during a March 2022 advisory committee meeting for the drug. “However, we have considerable concerns that the data may not be sufficiently robust to meet the approval standard for substantial evidence of effectiveness.”
"We hope that the new leadership will continue and accelerate (Dunn’s) efforts and not move backward."
Calaneet Balas
CEO, The ALS Association
The drug was later approved in September 2022 after the company submitted new analyses that supported its benefits, and the same panel of experts voted 7-2 in favor of the therapy’s approval.
In a statement to PharmaVoice regarding Buracchio’s appointment, Calaneet Balas, CEO of The ALS Association, said: “We hope that the new leadership will continue and accelerate (Dunn’s) efforts and not move backward. To make ALS livable we need an FDA that moves as quickly as possible and puts the needs of people living with ALS at the forefront of its decision making.”
Why it matters: Today, the FDA is expected to make another major decision for a rare disease medication — this time for Reata Pharmaceutical’s Friedreich’s Ataxia treatment omaveloxolone — and it remains unclear whether Dunn or Buracchio will sign the agency’s order. According to a spokesperson from the FDA, Dunn’s retirement was effective immediately yesterday.
Making the situation murkier is the fact that the agency scrapped the independent advisory committee meeting for the drug last fall, leaving many in the industry guessing which way its final decision could go. There are currently no disease-modifying treatments for the rare degenerative neuromuscular disorder.
Some are also looking to Buracchio’s comments during the March 2022 adcomm meeting concerning Amylyx’s ALS candidate to draw distinctions between her and Dunn, and predict where the Reata decision could fall.
For instance, Baird analyst Brian Skorney retweeted his own comments yesterday from that meeting, stating: “To listen to Teresa Buracchio talk today about (the) need for replicate studies and risk of spurious findings and contrast to Billy Dunn at the last PCNS AdCom, it’s like they live on two totally different planets.”
Reata’s stock plummeted 30% yesterday upon news of the change in leadership.
