Open letter to President Trump from biopharma innovators, investors, and patient advocates regarding proposed FDA budget and personnel cuts.

The US is the undisputed global leader in medical product innovation thanks in no small part to the Food and Drug Administration’s (FDA) scientific expertise and regulatory transparency. US consumers are most likely to have first access to the world’s newest medicines. Consumers living in Europe, Canada, Japan, and Australia often must wait more than a year after the FDA approves a new drug before their foreign regulatory agencies approve the same medicine for their own consumers.

Efficient and effective U.S.-led biomedical innovation is a goal we all share. We want to help your Administration be the most pro-biomedical innovation in US history. We want to help you pursue policies that strengthen and modernize the FDA. With continued investment, our country has the potential to finally cure costly diseases like cancer and Alzheimer’s if we retain our competitive advantage with a functioning innovation ecosystem.

However, we are very concerned that public health will be put at risk if arbitrary and excessive staffing cuts are made to the FDA. Such cuts will threaten and delay the approval of new medicines, diagnostics and devices, jeopardize the safety of our food supply and animal products (medicines and feed), leave us ill-prepared to address emerging health issues, and risk the safety and quality of everyday products like cosmetics, dietary supplements and over-the-counter medicines.

Many of the potentially impacted staffers are experts working on important, breakthrough science that allows them to review and approve first in class new medicines and devices, oversee the U.S. blood supply, address shortages of life-saving drugs, inspect the farms and facilities that produce the foods we eat and coordinate responses to pandemics. Small drug companies that represent more than 70 percent of Phase 3 clinical trials are particularly reliant on FDA’s experienced and highly specialized personnel. We urge your Administration to look at ways to retain and expand FDA’s capabilities as they are not easily replaced.

FDA’s staffing is still not nearly commensurate with the level required to support the careful review of the pipeline of new innovative treatments in development. The biopharmaceutical industry already supports the agency by paying fees so FDA has the resources it needs to do thorough, high quality work and meet its performance goals.

We request a stop to cuts to the agency’s staffing and request that the FDA be empowered to continue to perform its critical work of ensuring the safety and efficacy of food and medicines for all Americans. Without a fully staffed agency, the US biopharmaceutical industry will be put at risk and American patients may have to wait longer for new treatments.

There is room for improvement and greater efficiency at FDA. We and fellow executives, investors, innovators, providers, and patient advocates would happily volunteer to help your Administration ensure that the US remains the global leader in biopharmaceutical innovation and regulatory expertise. Please let us know how we can work with you to successfully improve the nation’s health.

To join us in signing this statement, click here.

Shehnaaz Suliman, MD, MBA, MPhil

CEO | ReCode Therapeutics

Julia Owens, PhD

CEO | Verto Therapeutics | Executive Chairman, Sena Therapeutics

Amanda Banks, MD

Chief Development Officer | Ovid Therapeutics

Jeremy Levin DPhil MB BChir

Chairman and CEO | Ovid Therapeutics

G Diego Miralles, MD

CEO | AZURNA Therapeutics

Gina S. Chapman

CEO | CARGO Therapeutics

Adam Rosenthal, PhD

CEO & Founder | Star Therapeutics

Alise Reicin MD

President and CEO | Tectonic Therapeutic

Andrew Levin, MD/PhD

Partner | RA Capital Management

Grace E. Colón, PhD

Biotech CEO, Board Member | Fellow, American Institute for Medical and Biological Engineering

Ken Drazan MD

Chair & CEO | Arsenal Biosciences

Maria Fardis

Chair and CEO | Lassen Therapeutics

Nikole Kimes, PhD

CEO & Co-founder | Siolta Therapeutics

Charlene Liao, PhD

CEO and Board Chair | Immune-Onc Therapeutics, Inc.

Lyn Baranowski

CEO | Avalyn Pharma

Peter Kolchinsky, PhD

Managing Partner | RA Capital Management

Daniel Dornbusch

CEO | Excision BioTherapeutics

Ken Drazan

Chairman & CEO | ArsenalBio

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“Efficient and effective U.S.-led biomedical innovation is a goal we all share. We want to help your Administration be the most pro-biomedical innovation in US history. We want to help you pursue policies that strengthen and modernize the FDA. With continued investment, our country has the potential to finally cure costly diseases like cancer and Alzheimer’s if we retain our competitive advantage with a functioning innovation ecosystem.”

We request a stop to cuts to the agency’s staffing and request that the FDA be empowered to continue to perform its critical work of ensuring the safety and efficacy of food and medicines for all Americans. Without a fully staffed agency, the US biopharmaceutical industry will be put at risk and American patients may have to wait longer for new treatments.”