FDA Veteran Woodcock Being Considered to Lead Agency Under Biden

(Bloomberg) -- Janet Woodcock, a 30-year veteran of the Food and Drug Administration, is being considered by President-elect Joe Biden to serve as commissioner of the agency, according to people familiar with the selection process.

Woodcock is expected to serve as acting head of the drug regulator after Biden’s inauguration next week, while being vetted by the Biden team for the permanent job along with former FDA principal deputy commissioner Joshua Sharfstein, according to the people.

Earlier this year, Woodcock stepped aside as director of the FDA’s Center for Drug Evaluation and Research to lead an effort to accelerate Covid-19 therapies under Operation Warp Speed. She remains in that role and is advising FDA Commissioner Stephen Hahn, who is expected to depart the agency at the end of President Donald Trump’s term.

Woodcock started at the FDA in 1986, and in recent years there were reports that she could retire. She is relatively new among the names the Biden transition has considered for the role, while Sharfstein has been on the short list since Biden’s electoral victory.

A representative for the Biden transition team didn’t immediately respond to a request for comment. Woodcock and Sharfstein declined to comment.

The FDA has faced intense political pressure during the coronavirus pandemic, particularly from Trump, who has referred to the agency as “deep state” and accused staff of being slow to authorize Covid-19 vaccines and treatments to hurt him in the November election.

Woodcock has steered the agency through numerous high-profile controversies during her career. She led the agency’s drug center when it approved Merck & Co.’s Vioxx, which was taken off the market after the painkiller was linked to heart attacks and strokes, sparking Congressional inquiries and patient lawsuits.

She also led the response to a tainted blood thinner made in China that killed more than 200 Americans, and most recently oversaw recalls of millions of blood-pressure pills and other drugs that contained chemicals that may cause cancer.

Risk Approach

Some critics have faulted how Woodcock approaches drug safety, leaning on companies to ensure the quality of their products rather than ramping up FDA oversight. But she was also responsible for developing a risk-based approach the FDA has taken since 2000 to focus its limited resources on issues that have the potential to cause the most harm.

Woodcock also has pushed to modernize pharmaceutical manufacturing to increase safety and encourage production in U.S. factories rather than overseas. Many companies rely on lower-cost foreign manufacturing to produce medicines, especially generic drugmakers, who make 90% of the drugs Americans take.

Sharfstein worked at the FDA under President Barack Obama and is currently vice dean for public health practice and community engagement at Johns Hopkins University’s Bloomberg School of Public Health. David Kessler, a Biden adviser who oversaw the FDA under Presidents George H.W. Bush and Bill Clinton, was reported by BioCentury to no longer be in the running for the top agency role.

If Biden were to choose Woodcock, it’s unclear whether she would remain acting commissioner during the confirmation process. There have been past instances where an acting head stayed in the post while lawmakers weighed their nomination. Andrew von Eschenbach was tapped as acting commissioner in 2005 and stayed until he was confirmed more than a year later.