Adapting to Change

Federal Policy Dynamics and the Pharmaceutical Industry

Molly Klote

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Paperback

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English

CRC Press
23 December 2026

Manufacturing industries; Pharmacy & dispensing; Biology, life sciences; Engineering: general; Pharmaceutical technology

The US pharmaceutical landscape is in the midst of impactful shifts. A series of ambitious, aggressive, and often interconnected federal policy changes—from direct drug price controls and sweeping Pharmacy Benefit Manager reforms to strategic initiatives to reshore manufacturing and rapidly evolving FDA approaches—is creating a new reality for industry leaders, innovators, and strategists.

In this analysis, a federal policy expert unpacks the complex forces reshaping how life-saving therapies are researched, developed, manufactured, and delivered.

By: Molly Klote
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 216mm, Width: 138mm,
ISBN: 9781041159803
ISBN 10: 1041159803
Pages: 120
Publication Date: 23 December 2026
Audience: College/higher education , Professional and scholarly , Primary , Undergraduate
Format: Paperback
Publisher's Status: Forthcoming

Dr. Molly Klote is the former Director of the US Department of Health and Human Services Office for Human Research Protections (OHRP). OHRP is the policy, education and compliance office that oversees federally funded medical research for 21 federal agencies, 13,000 institutions and >6000 institutional review boards in the US and internationally. It is the proponent office for the policy that is called “The Common Rule” (45 CFR 46). Before joining OHRP, Dr. Klote spent six years as the research policy, regulatory, and education lead for the Veterans Health Administration, the largest integrated healthcare system in the United States. Prior to the Veterans Health Administration, she served 30 years in the Army with her final assignment at the rank of Colonel working for the Army Surgeon General overseeing all US Army Human Research policy and compliance. Additionally, Dr. Klote has directed two major research program offices, chaired three Institutional Review Boards, and led a Research Scientific Review Board. She recently launched her own consulting company, Klote Medical Research Advisors, LLC to bring her over 36 years of distinguished military and civilian federal experience to those who need to better understand federal research policy.