FDA Task Force: Ensuring Access to Safe and Effective Treatments

If the complicated maze of the FDA approval process and clinical trials leave you dumbfounded, join us for a brief introduction to the FDA and its history, and learn more about DFA’s new FDA Task Force. The task force is a group of physicians working together to support and strengthen the FDA to ensure medical products meaningfully improve the clinical outcomes of our patients. The hope is that the FDA Task Force will serve as a counterweight to industry-funded voices (including other medical professional societies) towards ensuring regulatory policies proposed within the agency itself or Congress are based on scientific evidence and prioritize patients above all else. 

We are re-launching the FDA Task Force with support from Arnold Ventures and will be having our kickoff meeting in early March. Learn more about this exciting work and see if you would like to be involved. 

After attending this event, participant should be able to:

1. Understand the workings and history of the FDA
2. Learn about the Prescription Drug User Fee Act (PDUFA) and how the FDA’s budgetary dependence on user fees may advantage PhRMA in negotiating favorable policy changes through PDUFA
3. Recognize how you can translate your clinical experience into advocacy to ensure that all FDA and Congressional regulatory processes are based on scientific evidence

Session speakers:

Aaron Mitchell, MD MPH

Aaron Mitchell is an Assistant Attending at Memorial Sloan Kettering Cancer Center, where he practices as a medical oncologist and health services researcher. After graduating from NYU School of Medicine, he completed his internal medicine training at Duke University Hospital and medical oncology fellowship at University of North Carolina at Chapel Hill. He received an MPH in Epidemiology from UNC’s Gillings School of Global Public Health, and completed a postdoctoral research fellowship at UNC’s Cecil G. Sheps Center for Health Services research. He joined Memorial Sloan Kettering in 2018.

His research interests are in drug pricing, drug regulatory policy, and the determinants of oncology practice patterns, with a particular focus on financial determinants such as reimbursement policy and physician-industry conflict of interest. He seeks to understand how changes to current drug pricing models and reimbursement models for oncology services may be used to achieve better patient outcomes and reduce low-value care. He previously led a study funded by ASCO’s Conquer Cancer Foundation to assess oncologists’ responsiveness to reimbursement incentives to use high-cost, low-efficacy drugs, and he continues to study physician-level factors associated with use of low-value prostate cancer treatments with support from the National Cancer Institute. Additionally, he has led a series of studies analyzing the influence of financial relationships with the drug industry on physician practice patterns, published in JAMA Internal Medicine, JAMA Oncology, and Annals of Internal Medicine.

His clinical interests are in genitourinary malignancies; in addition to his primary appointment in Memorial Sloan Kettering’s Department of Epidemiology and Biostatistics, he holds a co-appointment in the Genitourinary Oncology Service, treating patients with prostate and bladder cancer.

John Powers III, MD FACP FIDSA

Dr. Powers is a physician/investigator on faculty as a Professor of Clinical Medicine at the George Washington University School of Medicine. Prior to his current position, Dr. Powers was the Lead Medical Officer for Antimicrobial Drug Development and Resistance Initiatives at the US Food and Drug Administration. Dr. Powers was co-chair for the US Federal Inter-Agency Task Force on Antimicrobial Resistance. He also was a co-author on the Guidance for Patient Reported Outcomes, and Chair of the ISPOR Clinical Outcomes Assessment task force. Prior to joining the FDA, Dr. Powers was assistant professor in the Division of Infectious Diseases at the University of Maryland School of Medicine and he still is on the faculty there. Dr. Powers also actively cares for patients and attends on the infectious diseases inpatient service.

Dr. Powers has been an investigator on over 60 clinical trials. He has particular expertise in the design, conduct and analysis of clinical trials and has published on various aspects of clinical trial design and outcome assessments. He has won several teaching awards, was nominated for the 2008 Distinguished Clinical Teacher Award by the National Institutes of Health Fellows Committee and recipient of the 2020 Norman P. Salzman mentoring award. He is a recipient of the 2010 and 2020 NIH Director’s Award, the US Veterans Administration public service award, and an award for public service from the Public Health Service.

Dr. Powers received his bachelor’s degree and graduated magna cum laude from the University of Pennsylvania. He received his medical degree and residency training in internal medicine from Temple University School of Medicine, where he also served as Chief Resident. He completed his infectious diseases training at the University of Virginia School of Medicine.

Moderator – Reshma Ramachandran, MD, MPP

Reshma Ramachandran, MD, MPP, (VA Scholar) is a board-certified family physician and second-year fellow within the Yale National Clinician Scholars Program. Her research focuses on the realignment of incentives for healthcare stakeholders including pharmaceutical companies, hospitals, and universities towards prioritizing equitable patient access to safe, effective health technologies. Prior to this role, Reshma worked as research faculty as part of the Innovation + Design Enabling Access (IDEA) Initiative at the Johns Hopkins Bloomberg School of Public Health, where she focused on policies to address the global challenge of antimicrobial resistance and unaffordable access to prescription drugs. Dr. Ramachandran trained in both medicine at the Alpert Medical School at Brown University and in public policy at the Harvard Kennedy School of Government. She completed her family medicine residency at Kaiser Permanente Los Angeles Medical Center. Previously, she served as the first PharmFree Fellow with the American Medical Student Association focused on removing the undue influence of pharmaceutical companies on prescribing behavior and medical education. She serves as Chair of Doctors for America FDA Task Force. She also is a board member of Universities Allied for Essential Medicines (UAEM) North America and the American Medical Student Association Foundation.