CPHI Podcast Series: US drug policy – exploring the executive orders

The latest episode of the CPHI Podcast Series provides a timely overview of the recent policy changes in the USA, with President Trump signing excecutive orders to change drug pricing under a 'Most Favoured Nation' scheme.

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. It is the proponent office for the policy that is called the Common Rule (45 CFR 46).  

She recently launched her own consulting company, Klote Medical Research Advisors to bring her over 36 years of distinguished military and civilian federal experience to those who need to better understand federal research policy.  

Dr Klote is a proud graduate of James Madison University in Virginia and the Uniformed Services University of the Health Sciences in Maryland, where she earned her medical degree. She is board-certified in Allergy and Immunology and conducted and published research regarding vaccines and immunodeficiency.

In her final Army career assignment as a physician in the U.S. Army Medical Corps, Dr Klote served as the Director of the Army Human Research Protections Office in the Office of the Army Surgeon General. In this capacity, she oversaw all Army policy and compliance related to academic, biomedical, socio-behavioural, and engineering research. 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.

Dr Klote’s leadership and unwavering commitment to enhancing human research protections and streamlining research regulatory have significantly advanced healthcare and research initiatives throughout her career.

In this episode Molly gives an initial introduction to several acts that are in process in the US, such as the Inflation Reduction Act, and then the more recent executive orders on trade tariffs and drug pricing. 

She highlights how these changes will have an impact on certain fields more than others, such as in R&D and the development of orphan drugs and drugs for rare diseases. She strickes a balance by demonstrating that there are also benefits, in terms of patient compliance if drugs are more affordable. 

Over the coming years we will certainly be seeing several shifts in how the pharmaceutical industry in the USA, and with ripple affects globally, will manifest and the impacts on supply chains. 

For more expert insights, listen to the full episode here.