On Tuesday, Sen. Ted Cruz (R-TX) co-authored a letter to Commissioner Stephen Hahn of the U.S. Food and Drug Administration (FDA) calling out the agency and requesting more information regarding its revocation of the Emergency Use Authorization (EAU) for hydroxychloroquine and chloroquine in treating COVID-19.
U.S. Sens. Ron Johnson (R-WI) and Mike Lee (R-UT) also signed the letter.
The document cites licensed physicians who have said that the federal government’s EUA revocation has resulted in state agencies attempting to quash the off-label use of the drug.
While the letter does not list specific physicians, several practicing medical doctors recently promoted the use of hydroxychloroquine and expressed similar concerns in a town hall meeting hosted by state Sen. Bob Hall (R-Edgewood).
Cruz, Johnson, and Lee wrote that physicians have indicated to them that hydroxychloroquine is useful in “early outpatient treatment.”
“These physicians have pointed to the low mortality rates in other countries – like India, Turkey, South Korea, and Morocco – that are using [hydroxychloroquine] widely on outpatient COVID-19 populations before the disease progresses to more lethal stages of the virus that require hospitalization,” the senators wrote.
Expressing concerns about “misinformation and confusion” regarding the acceptability of hydroxychloroquine prescriptions, the senators also warned Hahn that the FDA’s actions against the use of hydroxychloroquine could be increasing mortality.
“[P]hysicians are concerned that the FDA’s actions regarding [hydroxychloroquine] may be directly costing lives by limiting outpatient access to this potential beneficial treatment,” they wrote.
The FDA pulled the EUA for hydroxychloroquine and chloroquine in June, citing “ongoing analysis and emerging scientific data.”
“We made this determination based on recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery,” the FDA said.
However, Cruz, Johnson, and Lee have requested more information about the specific studies the FDA used to make the decision, emphasizing studies that address “post-exposure outpatient treatment and/or pre-exposure prophylaxis” as opposed to studies that focused on treatment in the later phases of the coronavirus disease.
The senators also requested information about what the FDA has done to make treatments available in the U.S. that have worked in other countries, as well as steps the agency has taken to clarify that state government may not bar the use of a prescription drug.
There has been anxiety among some Texas doctors who use off-label treatments such as hydroxychloroquine to treat patients with COVID-19. Some have been reported to the Texas Medical Board (TMB).
TMB President Dr. Sherif Zaafran asserted this week that the TMB does not inhibit the use of hydroxychloroquine by physicians, although the agency has been accused of trying to intimidate doctors who use off-label treatments.
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Hayden Sparks is a reporter for The Texan in Dallas. During the academic year, he coaches high school competitive speech and debate and has also been involved in community theater and politics. A native Texan, Hayden served as a delegate at the Republican Party of Texas Convention in 2016. He is on track to receive a bachelor’s degree in psychology from Liberty University. In his free time, Hayden is known to take walks around the neighborhood while listening to random music on Spotify.