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# Confirm Overton Now: Kathleen Jaeger
- URL: https://www.fdaweb.com/confirm-overton-now-kathleen-jaeger/
- Published: 2026-11-11T23:56:00.000Z
- Updated: 2026-11-11T23:58:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General

Among the many issues facing Congress before the end of the year, it should confirm **Heidi Overton** as FDA commissioner, according to healthcare strategy and consulting firm Medsecurean founder and CEO **Kathleen Jaeger**, who previously was CEO of the Generic Pharmaceutical Association (now the Association for Accessible Medicines). Writing in an online *RealClear Health* opinion piece, Jaeger [says](https://www.realclearhealth.com/articles/2026/11/10/a%5Fstrong%5Ffda%5Fis%5Fessential%5Fright%5Fnow%5F1216116.html?ref=fdaweb.com), “FDA’s responsibilities are too consequential for prolonged uncertainty in its leadership…. \[Overton\] can provide the continuity, accountability, and sustained direction needed to advance the agency’s scientific and public health mission. The importance of that leadership transcends administrations and election cycles.”

The column cites three instances (2019, 2021, and 2026) in which former commissioners came together to urge confirmation of a commissioner so FDA could keep pace with scientific progress in an increasingly competitive world.

She writes that rather than the challenges the agency faced several years ago easing, they have grown more consequential, placing increasingly more complex demands on FDA and underscoring the importance of strong, experienced leadership.

“Today, the United States faces intensifying competition from China in biotechnology, strategic dependence on Chinese key starting materials and intermediates used to manufacture affordable generic medicine, and growing pressure to restore the balance between U.S. pharmaceutical innovation and affordable competition,” she writes. “These are not separate problems. Together, they raise a fundamental question about America’s ability to discover, develop, manufacture, and reliably access innovative and affordable medicines upon which its health and economic prosperity depend. FDA has an essential role in addressing these challenges.”

Jaeger defines the agency’s role as helping to:

- sustain U.S. leadership in biomedical innovation at a time when China is rapidly advancing its biopharmaceutical capabilities;
- strengthen America’s medicine security by mitigating our strategic dependence on China for key starting materials and intermediates used to manufacture affordable generic medicines; and
- restore the fundamental U.S. public bargain established under Hatch-Waxman, rewarding pharmaceutical innovation while ensuring timely access to affordable generic competition.