Lupus Research Alliance Thanks FDA for Responsiveness Re Letter Citing Plaquenil Shortages
Lupus Research Alliance Thanks FDA for Responsiveness Re Letter Citing Plaquenil Shortages

May 7, 2020

The Lupus Research Alliance held an informative call with the Food and Drug Administration (FDA) in response to the letter spearheaded by the Lupus Research Alliance (LRA) Scientific Advisory Board Chair, Dr. Gary Koretzky, and co-signed by more than a dozen international leaders in Immunology, Rheumatology and Bioethics representing academia, industry and the American College of Rheumatology.

Dr. Gary Koretzky, along with Kenneth Farber, LRA President and CEO, and Dr. Teo Staeva, LRA Chief Scientific Officer, had a very productive discussion with the FDA regarding the recent hydroxychloroquine|Plaquenil shortages that people with lupus have found amidst the COVID-19 pandemic. The LRA leadership was reassured by the Agency’s ongoing efforts to address this issue for people with lupus and other rheumatic conditions. The FDA urged the LRA to remain in touch with the Agency as the situation continues to evolve.

The LRA expressed our Organization’s concerns about the portrayal of hydroxychloroquine|Plaquenil in the media as highly dangerous and the anxiety this is causing in our patients many of whom have been taking this medication for decades. The FDA acknowledged that it had received several inquiries regarding potential adverse events from hydroxychloroquine in patients on chronic therapy.  In response, the FDA has modified the recent Drug Safety Communication to include “Does not affect FDA-approved uses for malaria, lupus, and rheumatoid arthritis.” The LRA is grateful to the Agency for this swift and important action and hopes it will help alleviate the concerns expressed by patients who use hydroxychloroquine|Plaquenil for lupus.

The Lupus Research Alliance asks our constituents to complete this brief survey about your specific experience with Plaquenil supply. We will compile your feedback and relay it to the FDA. This specific attempt to collect information from the lupus community is entirely envisioned and driven by the LRA. The FDA neither suggested nor expected this input.

“The FDA’s responsiveness to the challenges faced by the lupus community was very encouraging,” noted Mr. Farber. “We urge people with lupus to answer our call for your reports so we can continue to keep the FDA apprised of the situation and request further assistance if needed.”

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