Senator Marsha Blackburn (R-TN) this week urged U.S. Food and Drug Administration officials to address shortages of drugs used to treat patients with lupus.
Hydroxychloroquine and chloroquine, used to treat autoimmune diseases like lupus, are currently used to treat COVID-19.
“We should not be facing a choice between treating lupus and COVID-19,” Blackburn said in a statement.
“We have to fix our U.S. drug supply problem right now. All Americans should be able to trust that they will not be the population left behind while we identify treatment for COVID-19.”
This follows Blackburn’s and U.S. Democratic Sen. Bob Mendendez’s introduction of the bipartisan Securing America’s Medicine Cabinet Act, which seeks to address the fact that more than 70 percent of the ingredients used to make pharmaceuticals are manufactured overseas. The SAM-C Act will encourage pharmaceutical drug manufacturers to spur innovations similar to those in other industries such as automotive, aerospace and semiconductors and bring drug manufacturing back to the United States. U.S. Republican Sen. Tom Cotton of Arkansas and U.S. Republican Sen. Martha McSally of Arizona have joined as cosponsors, the press release said.
Blackburn, in a letter to FDA Commissioner Stephen Hahn, said lupus affects women of childbearing age.
“I have been contacted by Tennesseans who have lupus with concerns about access to hydroxychloroquine and chloroquine. Recent news reports echo those concerns. In addition, the American Society of Health-system Pharmacists (ASHP) reported shortages of both of these drugs on March 24, 2020,” Blackburn wrote.
“Please carefully consider that there have been previous shortages, unrelated to the current COVID19 pandemic. These two drugs were listed on the FDA drug shortages website on March 31, 2020. Notably, chloroquine has only one manufacturer listed. The COVID19 pandemic is an unprecedented situation that requires thoughtful decision making.”
Blackburn asked Hahn to address the following questions and concerns before April 17:
• Please explain the discrepancy of the date of the current shortage of chloroquine and hydroxychloroquine reported by FDA and ASHP.
• How does the FDA collect information about potential drug shortages?
• Are chloroquine and hydroxychloroquine “essential medicines” included in the Strategic National Stockpile (SNS)? If so, how much is stockpiled? If not, why not?
• When the Emergency Use Authorization was released for the use of chloroquine and hydroxychloroquine for COVID19, did officials anticipate or consider the possibility of shortages of these medications? If so, please explain what considerations where made. If not, why not?
• What steps is FDA taking to mitigate the effect of these shortages on patients with lupus who depend upon chloroquine and hydroxychloroquine?
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