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:
Chairman and Chief Executive Officer
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 email@example.com.
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
Demand Progress Education Fund
Doctors for America
End AIDS Now
Faith in Healthcare
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 Health Institute (South Korea)
Pharmaceutical Accountability Foundation
Project on Government Oversight (POGO)
Protect All Children’s Environment
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