Joe Biden’s massive FDA determination

Whoever chooses President Joe Biden to head the Food and Drug Administration faces a daunting challenge: rebuilding an agency that was demoralized and tarnished during the Trump era.

Restoring the agency’s reputation will be an important part of ongoing efforts to eradicate Covid-19. More coronavirus vaccines are expected to be pending approval in the coming months, and renewed confidence in federal regulators could allay some public concerns about the vaccines. (As a reminder of how bad things had got in the Trump administration, the former president accused the FDA of being part of the “Deep State” for its vaccine review.)

Biden’s advisors told me ahead of the presidential election that, like any operational changes they might make to power, it was his administration’s responsibility to restore public confidence in America’s scientific leadership. That work starts with the FDA.

“Much of their role will be to undo the damage done to the agency’s reputation under the Trump administration,” said Rob Smith, who prosecutes the FDA for investment advisory firm Capital Alpha. “I think it will be important to have a strong commissioner who is seen as independent and has no obligation to the White House or to industry.”

Still, Biden’s election as FDA commissioner should say something about the new administration’s political plans. The field appears to be limited to two candidates, based on various media reports: current acting Commissioner Janet Woodcock and former Deputy Chief Commissioner Joshua Sharfstein, who is now with Johns Hopkins.

Each candidate would be tasked with restoring the FDA’s shine. Beyond this primary goal, they represent two different avenues for the agency under Biden.

Janet Woodcock: The institutional choice

Woodcock will serve as the acting FDA commissioner, assuming the office of new president on the first day of his term until a standing candidate is named and confirmed by the Senate. For the past 25 years she has largely headed the Agency’s Drug Evaluation and Research Center, which is responsible for evaluating prescription drugs.

Given Woodcock’s long tenure and her well-established role in the federal response to Covid-19 – she oversaw Operation Warp Speed’s work on potential therapies – experts aren’t too concerned about the lack of a Senate-confirmed commissioner at the FDA being. Woodcock is a steady hand at the wheel.

The question is, will she get the job full-time? Her experience and influence within the agency seem to be strong points on her résumé.

“She’s a career officer, not a political hack,” said Smith. “In terms of agency morale, it could go a long way if either of you came first.”

Woodcock’s long experience also explains one of her weaknesses: groups focused on the opioid epidemic are urging Biden not to appoint her permanently, given that CEDR has a role in the approval of prescription opioids.

In general, Woodcock would be more likely to represent a “business as usual” approach that has been anchored in the FDA for a quarter of a century. Your experience is your selling point. A Los Angeles Times composed of a group of cancer researchers and patient advocates cited Woodcock’s ability to “restore confidence in the FDA” as campaigning for her nomination.

The next commissioner will have a full plate even if the Covid-19 pandemic is under control. Biogen is in the midst of a controversial evaluation of a drug for Alzheimer’s disease. The FDA must reach an agreement on usage fees with the drug industry and Congress in the coming months. This must-pass legislation, which sets the agency’s budget, is often the vehicle for changes to FDA policy, so the Commissioner plays an important role in these talks.

Joshua Sharfstein: The reformer candidate

Woodcock’s obvious top rival Sharfstein would also bring FDA experience to the top job – but his agenda is also expected to deviate on important points.

The Marylander, who once worked under longtime chairman of the health committee, Rep. Henry Waxman, was the agency’s chief deputy commissioner in the early years of the Obama administration. He left his home state health department in 2011 and joined the Johns Hopkins School of Public Health in 2014.

During his previous tenure with the FDA, Sharfstein released an internal review that challenged the agency’s recent approval of a knee implant. He then tried to revise how medical devices are rated. In academic articles, he has suggested that the FDA commissioner publish data that is not currently published on agency-reviewed drugs. One step he argues could be taken without action by Congress.

“In downtown circles, Sharfstein is something people fear a little,” said Smith. “He will be more open to reform, more to the left-wing section of the Democratic Party.”

He’s also reportedly “bumped into career workers at times,” according to Politico, which reportedly gave Biden’s team a break from making him a commissioner.

Another name has sometimes been rumored for the FDA commissioner: Amy Abernethy, who joined the FDA under Trump and received internal praise for her work in modernizing the agency’s technology. But alongside Sharfstein and Woodcock, she is more of a dark horse than a top contender.

The FDA job will be a central point in the Biden administration. The two best candidates, both with their own clear strengths and potential weaknesses, have good choices.

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