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Limits of Woodcock’s Role Highlight Need for Permanent FDA Head

June 1, 2021, 9:12 AM

Acting FDA Commissioner Janet Woodcock is a big proponent of modernizing the clinical trial system, but focusing on such a long-term project will be difficult without a permanent spot as agency leader, FDA advocates say.

There’s a 210-day statutory limit for how long an acting commissioner can work in a Senate-confirmed role. That means the 35-year veteran could only remain in her role until mid-to-late August unless President Joe Biden nominates her or someone else to the spot beforehand, according to the nonprofit Alliance for a Stronger FDA.

“While Janet Woodcock is doing an excellent job running the agency, and is clearly the most qualified Acting FDA Commissioner we have ever had, not having a permanent commissioner presents uncertainty in and outside the agency,” said Ellen Sigal, founder and chairperson for Friends of Cancer Research.

Having a permanent head would help get the agency back on track after a year of diverting resources toward dealing with the pandemic, according to some lawmakers.

“We’d like to get this thing resolved,” Rep. Fred Upton (R-Mich.) said at a mid-May event held by the Alliance for Regenerative Medicine. “We’ve known that President Biden’s won since November. So let’s get with it and get someone in there.”

So far, the Biden administration hasn’t named a permanent head for the agency. Woodcock is one of the frontrunners and one of the most experienced FDA staffers to take on this role.

Lawmakers Are Antsy

Woodcock joined the Food and Drug Administration in 1986 and spent about 25 years running the Center for Drug Evaluation and Research, which is the largest of the agency’s six centers. She has overseen a number of changes through the Critical Path Initiative to revamp the way the FDA regulates medical products.

But as an acting commissioner, she can’t start any initiatives or change the agency’s direction.

Woodcock has called for transforming the U.S. clinical trials enterprise for at least a decade, arguing the system consists of too many small, under-powered trials that don’t generate the evidence needed.

Upton and Rep. Diana DeGette (D-Colo.) have praised Woodcock, who became acting commissioner in January, as a good choice. DeGette also stressed having a permanent leader as “really critical.”

“They need to get somebody in that position who can really take them to the next level and to implement all of the changes we made, not just in 21st Century Cures, but also the breakthrough therapies bill that was expanded by Cures,” she said at the Alliance for Regenerative Medicine event.

DeGette was referring to a landmark law enacted in 2016 that gives the FDA more resources to hire and retain scientists and accelerate drug and device development. Draft legislation to update that law is expected to come out in early June.

FDA’s Future

Career officials run the day-to-day operations of the agency, and commissioners aren’t the only people who decide what priorities the agency will set. But each FDA commissioner focuses on a project or issue they highlight as especially important.

Scott Gottlieb, former commissioner under the Trump administration, focused on regulatory loopholes that exacerbated high drug prices or shortages. Gottlieb’s successor, Stephen Hahn, had his hands largely full dealing with the Covid-19 pandemic, but he said at the beginning of his tenure he was particularly interested in weaving more evidence from real-world situations into policy decisions.

The agency also has to keep up with day-to-day obligations, like approving drugs and devices, hiring scientists and other staff, and inspecting medical product facilities.

The pandemic forced many parts of agency duties to go virtual, like inspections for most facilities. The silver lining, officials say, has been more acceptance of remote work possibilities.

That, paired with more resources from the Cures Act, has given the agency more room to expand hiring because people won’t necessarily have to work at the FDA’s headquarters, CDER Director Patrizia Cavazzoni said last week.

“We are very interested in exploring, obviously within the limitations of the government rules, how we can get to a new normal, where employees have more flexibility to work remotely,” she said.

Technology

Modernizing the agency’s workforce is not all the FDA has to do to remain nimble. It also needs to update its technology infrastructure.

Woodcock has said she wants to create modern clinical trial designs with more advanced technology platforms so data can be stored and used more efficiently. That’s difficult to accomplish in an acting capacity, but that hasn’t stopped her from talking about it publicly.

“What we need to do is really build enterprise-wide platforms using available, off-the-shelf software that we can utilize across the agency, and then transition these processes and databases and everything onto those platforms,” Woodcock said at an event in April.

“Basically, we really have very high-cost systems where we do not get the return on investment that we need,” she said.

To contact the reporters on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com; Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

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