Joint Statement Urging White House Coronavirus Task Force, the leadership of the U.S. Congress and Nation’s Governors to Ensure Hydroxychloroquine Access During COVID-19 Crisis
Below (or download PDF) is a joint statement by the Lupus Foundation of America, American College of Rheumatology, American Academy of Dermatology, and the Arthritis Foundation urging the White House Coronavirus Task Force and nation's governors to ensure Hydroxychloroquine access during the COVID-19 crisis.
The Honorable Mike Pence
Vice President of the United States
The White House
Washington, DC 20500
Dear Vice President Pence:
We write to you as organizations that represent patients and physicians who have extensive experience with the antimalarials, hydroxychloroquine and chloroquine, which are under investigation as potential treatments for Coronavirus (COVID-19). Both medications have been successfully used to treat lupus and rheumatoid arthritis for decades. We are concerned that increased demand for these drugs attributed to COVID-19 has exacerbated their already limited availability for patients who rely on them to meet their medical needs. Therefore, we urge you to work with us and the broader health care community to help ensure continued availability of these drugs for the patients who are maintained on them to avoid disability, illness and even early death.
Tens of thousands of Americans currently are prescribed hydroxychloroquine and chloroquine for lupus and rheumatoid arthritis, particularly when a patient’s symptoms do not respond to other treatments. In fact, lupus, rheumatoid arthritis and malaria are the only indications for which these drugs are approved by the Food and Drug Administration (FDA). In many cases, there are no alternatives to hydroxychloroquine or chloroquine. For patients with lupus, hydroxychloroquine is the only medication shown to increase survival. Hydroxychloroquine is the cornerstone of therapy, used in most patients unless a contraindication exists. Already today, many of our patients are not able to fill their prescriptions, due to major shortages of hydroxychloroquine, with validated reports across the country of pharmacies having depleted their supplies and half of the drugs’ manufacturers reporting backorders.
To date, limited data supports the efficacy of hydroxychloroquine and chloroquine for COVID-19. While we support rigorous clinical trials to investigate their potential use for COVID-19, it is imperative to preserve access to these medications for those patients whose lives and productivity depend on them. Specifically, we urge you to:
- Work with the pharmaceutical industry, pharmacies and the FDA to:
- increase monitoring and timely reporting of shortages and to mitigate the shortage that has resulted from an increased demand for these drugs;
- utilize existing authorities to increase the production and supply of the drugs; and
- take action to ensure current supplies are allocated for patients taking them for indicated uses and that any increase in supply be available for continued access, not diverted for use in COVID-19.
- Communicate to the public, healthcare professionals, and other stakeholders accurate and up-to-date information about these drugs, their critical role in treatment for the current indications and the status of their use for COVID-19, including clinical trials underway and what is known or not known about the safety and efficacy of these drugs in COVID-19;
- Ensure sufficient supplies for the people who take these drugs for the indicated uses by implementing restrictions to minimize unnecessary prescribing or stockpiling of hydroxychloroquine and chloroquine solely for use in COVID-19;
- Monitor and take action as necessary to prevent unreasonable price increases or cost sharing for the drugs;
- Give patients who take these medications for indicated uses ongoing access to refills of a 90-day supply of these medications to prepare them for emergency in case of sudden shortage and establish policies to assist patients with cost-sharing related to emergency supplies;
- Limit prior authorization and utilization management practices that may delay access to these medications for those for whom the medications are indicated.
We recognize the urgent global need to find treatments for COVID-19 and to minimize the spread of the virus. Our organizations share these priorities. At the same time, we are committed to the health of the patients we serve, which includes making sure that they have timely access to the medications and care upon which they have relied for decades. We stand ready to work with you and other stakeholders in this effort.
Thank you for your consideration of our concerns during this time. If you have any questions, please contact Pat Wildman at email@example.com.
Stevan W. Gibson
President and CEO
Lupus Foundation of America
Ellen Gravallese, MD
American College of Rheumatology
George J. Hruza, MD, MBA, FAAD
American Academy of Dermatology
Ann M. Palmer
President and CEO
cc: White House Coronavirus Task Force
The Honorable Mitch McConnell
The Honorable Charles E. Schumer
The Honorable Nancy Pelosi
The Honorable Kevin McCarthy
United States’ Governors