Posted on September 11, 2020 at 8:14 PM
The Working Group on Compassionate Use and Preapproval Access (CUPA), a project of the NYU Grossman School of Medicine Division of Medical Ethics
The undersigned are members of a multidisciplinary group comprising bioethicists, clinicians, patient advocates, and representatives from industry and law who for the past seven years have been studying the ethical issues surrounding access to medical products before they have received regulatory approval. We support the U.S. Food and Drug Administration (FDA) as an institution and are concerned that its dedicated staff are facing a historically unprecedented threat to their mission from the White House.
On August 22, 2020, the U.S. president, via Twitter, accused the FDA of intentionally delaying development of COVID-19 vaccines and therapeutics to harm his reelection campaign. This unfounded claim, along with other statements from and actions by the president and members of his administration since the start of the pandemic, are undermining public confidence in the FDA. If American citizens are not confident that the agency is acting according to scientific evidence—and not to advance partisan political interests—they will not trust the products to which the FDA gives its regulatory imprimatur. This is especially dangerous in the context of vaccines, which are designed to be given to healthy individuals as a preventative, as opposed to a therapeutic agent for sick or ailing patients.
The FDA’s work has always relied on its committed and highly trained expert staff. Like all federal officials, FDA employees take an oath to “well and faithfully discharge the duties of the office,” the heart of which for the FDA is “protecting the public health by ensuring the safety, efficacy, and security of…drugs, biological products, and medical devices.” They must not be pressured to compromise their integrity, objectivity, or dedication to this duty by a “warp speed” mentality or artificial deadlines based on election cycles or partisan interests.
We urge the FDA, at every level of leadership, to resist pressures that have the potential to lead the agency away from its fundamental mission. Congress and academia must also stand up for the integrity of the FDA and protect the careful work of its dedicated, highly professional staff to ensure that our nation has access to only the most trustworthy medical products. The FDA has earned the trust of the American people and the world through the vigilance of its scientists and staff. That confidence must not be imperiled by political pressure or interference, particularly in the midst of a pandemic.
Arthur L. Caplan, PhD (CUPA chair)
Alison Bateman-House, PhD, MPH, MA (CUPA co-chair)
M. Sage Gustafson, MA (CUPA project manager)
Hayley M. Belli, PhD, MS
David R. Curry, MS
Nancy Dubler, LLB
Pat Furlong, MS, RN, BSN
Kay Holcombe, MS
Lisa Kearns, MS, MA
Laura Kimberly, PhD, MSW, MBE
Holly Fernandez Lynch, JD, MBE
Regine Nshimiyimana Maniraho, DNP, PharmB, FNP, AGACNP, AOCNP
Andrew McFadyen, BA, B.Ed
Lindsay McNair, MD, MPH
Jennifer Miller, PhD
Kenneth I. Moch, MBA
Christopher Robertson, JD, PhD
David I. Scheer, MS
Lesha D. Shah, MD
J. Russell Teagarden, DMH, MA
David Wallach, MPH, CIP
Tom Watson, BSc
Mary Elizabeth Williams