FDA’s Hydroxychloroquine Emergency Use Order for COVID-19 Draws Mixed Reactions
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Rheumatologists, rheumatology patients and the organizations who represent both have reacted this week with a mixture of hope and dread following the FDA’s decision allowing the emergency use of hydroxychloroquine to treat some patients hospitalized with COVID-19.
Their hope is based, at least in part, on comments from HHS that the hydroxychloroquine and chloroquine products to be used in this way have been donated to the Strategic National Stockpile (SNS), which the government said would alleviate supply pressures. Since comments regarding its possible — but still untested — potential as a COVID-19 treatment were made public, shortages of hydroxychloroquine have been reported across the United States, leaving many patients with lupus and rheumatoid arthritis in danger of being unable to access necessary treatment.
Scant Evidence, Less Guidance
Patient risks, however, are further compounded by the fact that the FDA has offered very little detail or guidance on hydroxychloroquine’s use in this population. It remains unclear, according to experts, how these drugs will be distributed, leading to fears of possible overuse.
“While it is encouraging for the lupus community that the HHS’ statement indicates that it will help ensure people with lupus have access to these medications, it is still unknown at this point as to exactly how the medications will get distributed and the overall impact of availability of the drugs for those who need the drugs now,” read a statement released by the Lupus Foundation of America, following a request for comment by Healio Rheumatology.
“The Lupus Foundation of America has been talking with key stakeholders and companies involved in the drug supply chain, including state boards of pharmacy, federal government and agencies and other important stakeholders — and our voices are clearly being heard,” the statement continued. “The actions from the FDA and HHS are certainly a step in the right direction, but our work is far from over.”
On March 28, the FDA issued an Emergency Use Authorization, which allowed hydroxychloroquine and chloroquine products that were donated to the SNS to be distributed and used for adolescent and adult patients hospitalized with COVID-19 who cannot be part of a clinical trial.
According to HHS, 30 million doses of hydroxychloroquine sulfate have been donated to the SNS by Sandoz, the genetics and biosimilars division of Novartis, and Bayer Pharmaceuticals donated 1 million doses of chloroquine phosphate to the national stockpile. The drugs have been provided for possible use in treating patients hospitalized with COVID-19, or for use in clinical trials, the department said.
“Use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis,” said HHS in a statement. “Some states and retail pharmacies also have taken action to preserve the supply of these and other drugs for these patients.”
Balancing Potential with Immediate Needs
However, despite these expectations, questions remain regarding what the FDA’s order will mean for patients with RA and lupus, according to the American College of Rheumatology. David Karp, MD, PhD, president-elect of the ACR, told Healio Rheumatology that the full impact of the Emergency Use Authorization will remain unclear until the supply chain is given time to react.
“We are still trying to determine what this will mean for our patients and likely won’t know the impact of the EUA until we see how the supply chain will react,” Karp said. “Until we know more of what this will mean, the ACR remains appreciative of the FDA’s efforts to walk the fine balance between providing hydroxychloroquine and chloroquine as potential treatments for COVID-19, while also ensuring continuity of care for our patients who have relied on these medications for years.”
Further, Alfred H.J. Kim, MD, PhD, of the Washington University School of Medicine, in St. Louis, Missouri, warned that although the FDA’s move seeks to limit hydroxychloroquine’s use to situations when clinical trials are not available, the lack of specifics limits any potential positive impact.
“The major caveat is that there are no appropriate use guidelines since the quality of clinical data supporting HCQ/CQ in COVID-19 is poor and heavily confounded, substantially limiting interpretative value,” he wrote. “The impact of the lack of guidelines for HCQ/CQ use opens up the possibility for overutilization in COVID-19 patients, such as use in any hospitalized patient or more worrisome, in prophylactic use where absolutely no data currently exist for this use.”
Additionally, some state boards of pharmacy, as well as at least four state governments, have taken immediate action to prevent future drug shortages related to potential COVID-19 treatments. Governors in Michigan, Nevada, New Jersey and New York have all announced their own restrictions on hydroxychloroquine and chloroquine to stem the recent run on the drugs.
In one example, New Jersey Attorney General Gurbir S. Grewal, JD, on March 30 imposed emergency, statewide limits on the prescription and disbursement of hydroxychloroquine and chloroquine to ensure availability for patients with RA and lupus. The order mandates that hydroxychloroquine or chloroquine — or any other in short supply due to use as a possible treatment for COVID-19 — may be prescribed and dispensed for treatment of COVID-19 only if supported by a positive test result, which must be documented on the prescription, and limited to a 14-day supply, with no refills permitted.
The order’s limitations do not apply to medications administered for inpatient hospital use, or for use in federal or state clinical trials. It also does not impact prescriptions for preexisting conditions, such as lupus or RA.
Guy Eakin, PhD, senior vice president of scientific strategy for the Arthritis Foundation, said more focus should be afforded to patients currently living with conditions that are appropriately treated with hydroxychloroquine. Their needs, he said, have been drowned out in the excitement surrounding the drug as a possible therapy for COVID-19.
“Lost in all the excitement over a treatment that may or may not work for COVID-19, are the people who depend on that drug to keep their disease under control,” Eakin told Healio Rheumatology. “We know they benefit from it, are more productive, live fuller lives and may even live longer. Rheumatoid arthritis and lupus are serious diseases, and so is COVID-19.”
“This is not about pitting one disease against another,” he added. “We are gratified to see so many rallying to protect supplies of hydroxychloroquine for these patients. The FDA, some state pharmacy boards, professional medical and pharmacy associations and our coalition of patient organizations are using what muscle we have to influence, regulate or hold accountable those who can ensure an adequate supply of the drug for its indicated uses.” – by Jason Laday