Did a dark horse candidate for FDA chief just emerge?

Dr. Amy Abernethy, chief information officer, resigns suddenly; no destination planned

With yesterday’s approval of Dr. Vivek Murthy as the nation’s Surgeon General, the Biden administration’s health care team is largely in place save one critical player: the all-important Food and Drug Administration commissioner.

A battle royal has raged for months between supporters of two FDA officials, one current and one former. They would bring sharply differing perspectives to the commissioner’s office.

The leading candidate, if measured by the noise generated by supporters and the amount of digital space given her possible nomination by reporters covering the agency, is Dr. Janet Woodcock, the 72-year-old acting commissioner. She’s spent much of her 35-year career at the FDA overseeing the approval of new drugs, vaccines and biologics.

She has drawn active and aggressive support from what I like to call the faster cures crowd. They include a phalanx of patient advocacy groups, most of which are heavily funded by the pharmaceutical industry, and many of the leading lights of the academic physician-researcher community, almost all of whom also have close ties to drug and biotechnology firms if they haven’t started their own companies.

Dr. Joshua Sharfstein, 51, a professor at the Johns Hopkins Bloomberg School of Public Health, is the favored candidate for public health and drug safety advocates. He also wins the nod from progressives in the medical community and on Capitol Hill ans has received public endorsements from every minority physician group (African-Americans, Hispanics, Asians and Native Americans), who appreciate his advocacy for health equity and diversity in clinical trials.

A former deputy commissioner during the Obama years, Sharfstein has served atop two public health agencies, first in Baltimore and then for the state of Maryland. While on the faculty at JHU, he’s been a frequent contributor to the medical literature on public health and regulatory issues.

The dark horse

But a potential dark horse candidate emerged yesterday: Dr. Amy Abernethy, who stepped away from her position as chief information officer at the agency after serving a little over two years. The former Duke University researcher spent the five prior years as chief medical officer at the bioinformatics firm Flatiron Health, which was bought by drug giant Roche in 2018 for $1.9 billion. She quit the FDA without a declared destination.

In an interview with Stat’s Matthew Herper, she voiced strong support for Woodcock getting the top job. It was a rather startling breach of protocol for someone holding the highest civil service position (not a political appointee) at the agency. But it might have been smart politics should Biden, feeling heat from the left, decide to pass on Woodcock and seek a more centrist-appearing alternative.  

Full disclosure on all fronts: I first met Dr. Sharfstein in the late 1990s, when I first took an interest in the drug industry and he was a young aide in Congressman Henry Waxman’s office. A decade later, while running the Integrity in Science project for the Center for Science in the Public Interest, I worked under Dr. Woodcock, then head of the Center for Drug Evaluation and Research, as an unpaid consumer representative on several FDA advisory committees. And about a decade ago, I interviewed Dr. Abernethy several times because of her pioneering work in using outcomes data from the off-label use of drugs to improve cancer care. My last interview with her was just two weeks ago for a session at the American College of Healthcare Executives, which was aired online today (no link available yet).

As I noted in a column earlier this month, I believe the Biden team should pick a top-notch public health official for FDA commissioner, someone in the mold of Dr. David Kessler, who held the job from 1990 to 1997 under Republican and Democratic presidents and led the successful fight against the tobacco industry. The agency’s reputation was badly tarnished by last year’s hydroxychloroquine episode and other Trump administration efforts to manipulate or ignore science when considering new drug applications.

It takes an outsider to right the ship

If Biden chooses the former top drug regulator at the agency, especially one who has taken heat for waving through several questionable drug approvals in recent years, it would make the job of rebuilding confidence in the agency that much harder. It would also be the first time since the mid-1960s that someone from inside the agency took over the top job on a permanent basis.

The last time that happened, things didn’t turn out well. In 1968, President Lyndon Johnson appointed Dr. Herbert Ley to run the agency after he spent several years in charge of what was then called the Bureau of Medicine. Over the next two years, he became enmeshed in a series of scandals involving the failure to remove a mislabeled drug from the market, allowing a dangerous additive (monosodium glutamate) in baby food, and delaying the removal of cyclamates from the food supply. The drum beat of bad press led to Congressional hearings and his eventual ouster from the job.

Yet Woodcock still has to be considered the front runner for the job since many of the people closest to the new president come from the patient-advocacy, faster cures world. So does the new president. When vice president, Biden spearheaded the Obama administration’s “cancer moonshot,” which was launched shortly after his son Beau died of brain cancer.

The biggest health problems facing America today are largely social and require comprehensive public health approaches – not better medical interventions. They include the opioid and obesity epidemics, declining longevity from deaths of despair, ongoing alcohol, tobacco and firearms abuse, and emerging environmental health problems. The FDA, which regulates one quarter of all consumer products, has a major role to play in addressing all of those problems through its oversight of food, tobacco and cosmetics, and its statutory authority to regulate product labels and advertising.

In my recent interview with Dr. Abernethy, she had solid ideas on how to apply information technology to advancing the mission at all six centers at the FDA (drugs, biologics, devices, food, tobacco and veterinary medicine). But it would take a major and rapid transformation in her intellectual outlook for her to become a champion for public health.