WASHINGTON — A management shuffle at the Food and Drug Administration Monday moved two officials into high-ranking positions, giving them more authority over the agency’s strategy.

Theresa Mullin is moving up from being the director of the office of strategic programs at the Center for Drug Evaluation and Research — starting Monday, she’s working directly in the office of the CDER director, Janet Woodcock, as the associate director for strategic initiatives, according to an email that Woodcock sent to her staff.

Meanwhile, Keagan Lenihan, a former political appointee at the Department of Health and Human Services and an ally of former HHS Secretary Tom Price, was hired directly into the FDA commissioner’s office, Politico reported. Lenihan will take on the role of associate commissioner for strategic initiatives.


Mullin has been at the agency for years, working as assistant commissioner for planning and then joining CDER in 2007, according to the FDA website. At CDER, she has taken charge of a wide variety of programs, at least some of which she will continue to manage in her new role, according to the email from Woodcock. In the email, Woodcock specifically mentioned Mullin’s work with patient engagement and international collaboration.

“CDER’s stake in these programs has also grown, and Theresa’s new role will ensure that these areas have the leadership and attention needed for continued success,” Woodcock wrote. “These critical initiatives require astute management as our external engagement continues to build.”

Over the past few years, Mullin has led the Patient Focused Drug Development initiative, a program created in 2012 with the goal of “obtaining the patient perspective on certain disease areas,” according to an agency webpage.

Since then, the FDA has held at least 21 meetings, each focused on a different disease, where agency officials have heard feedback from patients “on the impact of the condition on daily life and current treatment approaches,” Mullin wrote in a blog post in October 2016.

“Having this kind of input is extremely valuable for us because hearing what patients care about can help us determine how best to facilitate drug development for a particular disease area,” Mullin wrote. “Hearing the patients’ perspectives also helps us understand how patients view the benefits, risks, and burdens of treatments for their condition.”

Mullin will also continue her work on international cooperation.

In her former role, Mullin headed the FDA’s delegation to the International Conference on Harmonization, which helps drug regulators in different countries standardize procedures so they can more easily work together.

“International harmonization of regulatory standards means that pharmaceutical manufacturers and developers will be held to the same standards in different markets, which will make the development and delivery of quality pharmaceuticals to the public more timely and efficient,” Mullin wrote in an August 2017 blog post.

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