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Civil Society Letter to Gilead to Renounce Remdesivir Orphan Drug Claim

Letter from 51 groups to Gilead renounce remdesivir orphan drug claim

On March 25,  51 civil society organizations, led by Public Citizen, wrote Gilead Sciences to demand the corporation reverse course and renounce its claim to orphan drug designation privileges for remdesivir, one of relatively few medicines being explored as a possible treatment for COVID-19 this year.


The full text of the letter follows below:

Daniel O’Day

Chairman and Chief Executive Officer

Gilead Sciences

333 Lakeside Drive

Foster City, CA 94404

March 25, 2020


Dear Mr. O’Day,

We were shocked to learn that your company sought a lucrative orphan drug designation from the Food & Drug Administration for remdesivir, one of relatively few medicines being explored as a possible treatment for COVID-19 this year.

This is an unconscionable abuse of a program designed to incentivize research and development for treatments for rare diseases. COVID-19 is anything but a rare disease. Some estimates suggest that half or more of all Americans may ultimately contract the disease.

We are writing to demand you reverse course and renounce your claim to orphan drug designation privileges for remdesivir.

As you know, Gilead was able receive an orphan drug designation only by rushing to file its application while there were fewer than 200,000 COVID-19 U.S. cases.

The United States most likely will surpass 200,000 COVID-19 reported cases in a matter of days. The real number of people suffering with the new coronavirus likely already has passed this mark. Calling COVID-19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic.

The orphan drug designation would provide Gilead with seven years of marketing exclusivity, enabling you to exclude competitors and charge high monopoly prices while people struggle to gain access. It would also further subsidize any costs through additional tax credits and allow you to monopolize the supply of the drug during a public health crisis.

Making the claim to special orphan status even more outrageous is the fact that the public already has largely paid for remdesivir’s development through at least $60 million in grants and innumerable contributions from federal scientists. Public agencies around the world are sponsoring remdesivir’s clinical trials, including the National Institutes of Health and the World Health Organization.

America, and the world, has the right to expect better from Gilead.

We await your urgent response. Please contact Peter Maybarduk, Public Citizen Access to Medicines Program Director at pmaybarduk@citizen.org.



ACT UP Philadelphia

AIDS Action Baltimore

AIDS Healthcare Foundation

Alliance for Retired Americans

American Economic Liberties Project

American Medical Student Association

Americans for Democratic Action (ADA)

Americans for Tax Fairness

Center for Health and Social Change (CHSC)

CPD Action (Center for Popular Democracy)


Congregation of Our Lady of Charity of the Good Shepherd, U.S. Provinces

Consumer Action

Demand Progress Education Fund

Doctors for America

End AIDS Now

Faith in Healthcare

Families USA

Global Justice Now

GNP+ (Global Network of People living with HIV)

Health Care Voter

Health GAP (Global Access Project)

Korean Pharmacists for Democratic Society (KPDS)

Labor Campaign for Single Payer

Let’s Kick ASS

Lower Drug Prices Now

Médecins Sans Frontières Access Campaign

National Advocacy Center of the Sisters of the Good Shepherd

National Center for Health Research

National Latino Farmers & Ranchers Trade Association

National Women’s Health Network

NETWORK Lobby for Catholic Social Justice

Open Markets Institute

Patients for Affordable Drugs

People’s Action

People’s Health Institute (South Korea)

Pharmaceutical Accountability Foundation


Project on Government Oversight (POGO)

Protect All Children’s Environment

Public Citizen

Public Eye (Switzerland)



Social Security Works


Treatment Action Group

Universal Health Care Foundation of Connecticut

Universities Allied for Essential Medicines

Yale Global Health Justice Partnership