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Senator Marsha Blackburn Urges FDA to Respond to Critical Drug Shortages

 

U.S. SenateNashville, TN – Senator Marsha Blackburn (R-Tenn.) is urging the U.S. Food and Drug Administration to address shortages of drugs used to treat patients with lupus. Hydroxychloroquine and chloroquine, which are used to treat autoimmune diseases like lupus, are currently being used as treatment for Coronavirus (COVID-19).

“We should not be facing a choice between treating lupus and COVID-19,” said Senator Blackburn. “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.”

Senator Marsha Blackburn.

Senator Marsha Blackburn.

This follows Senators Blackburn and Bob Mendendez’s introduction of the bipartisan Securing America’s Medicine Cabinet Act, which seeks to address the fact that over 70% 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. Senators Tom Cotton (R-Ark.) and Martha McSally (R-Ariz.) have joined as cosponsors.

The full text of the letter is available below and here.

 

Dear Commissioner Hahn:

I write today with concerns regarding the availability of treatments for patients with systemic lupus erythematosus, commonly called lupus. As you know, this is an autoimmune disease that can cause significant illness. Women of child bearing age are particularly affected by this disease.

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 24th, 2020.  Please carefully consider that there have been previous shortages, unrelated to the current Coronavirus (COVID-19) pandemic. These two drugs were listed on the FDA drug shortages website on March 31st, 2020.  Notably, chloroquine has only one manufacturer listed.

The COVID19 pandemic is an unprecedented situation that requires thoughtful decision making.  

To address these concerns, please respond to the following questions by April 17th, 2020. If you have any questions, please contact my staff at 202.224.3344.

  1. Please explain the discrepancy of the date of the current shortage of chloroquine and hydroxychloroquine reported by FDA and ASHP.
  2. How does the FDA collect information about potential drug shortages?
  3. Are chloroquine and hydroxychloroquine “essential medicines” included in the Strategic National Stockpile (SNS)? If so, how much is stockpiled? If not, why not?
  4. When the Emergency Use Authorization  was released for the use of chloroquine and hydroxychloroquine for Coronavirus (COVID-19), did officials anticipate or consider the possibility of shortages of these medications? If so, please explain what considerations where made. If not, why not?
  5. 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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