FDA Recognizes Hydroxychloroquine and Chloroquine Shortages

On Tuesday, March 31, the Food and Drug Administration (FDA) posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage. The shortages are due to a significant surge in demand. The FDA shared the following:

“The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis. All manufacturers are ramping up production, and the agency’s webpage displays current availability. The FDA is working with manufacturers to ensure this can happen expeditiously and safely. The U.S. Department of Health and Human Services (HHS) has also accepted 30 million doses of hydroxychloroquine sulfate to the national stockpile and one million doses of chloroquine phosphate for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. Use of the donated medications is expected to help ease supply pressures for the drugs. This is a fluctuating and dynamic situation and the FDA is actively engaged. The agency is updating its shortages lists regularly and continuing to communicate in real-time so that patients and healthcare providers have the most current information on products in the U.S.”

The Lupus Foundation of America has spent the past several weeks identifying shortages of these medications, and has taken action through many advocacy and communication activities to raise awareness and address the shortage. 

For example, in our joint letter issued on March 23 to the White House Coronavirus Task Force, one of our requests with regard to this drug shortage included working with 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.” The Foundation also specifically urged the federal government to work with manufacturers to step up production of the drugs and has engaged the manufacturers directly in an effort to address the shortages and increase the supply of hydroxychloroquine and chloroquine available to people with lupus.  

Our advocacy efforts are clearly making an impact, but our work is not nearly done. Thank you to the thousands of lupus warriors for sharing their experiences and the impact that not having access to their medications is having on their health. 

As this drug shortage issue continues to evolve, know that we are having ongoing conversations with the FDA about the impact the hydroxychloroquine and chloroquine shortage is having on people with lupus and where we are seeing problems. We have also urged the FDA to ensure that increased production of these medications leads to increased supply to pharmacies and people with lupus. To see the actions we have taken to address access to hydroxychloroquine and chloroquine and for the latest updates on COVID-19 and lupus, visit lupus.org/coronavirus.