As patients face shortages, DeGette urges FDA to address hydroxychloroquine and chloroquine hoarding

Apr 8, 2020
Press Release

DENVER, CO – Tens of thousands of Americans rely on hydroxychloroquine and chloroquine to treat conditions such as lupus, rheumatoid arthritis and malaria. But as President Trump continues to flaunt these medications as a miracle cure to the novel coronavirus – despite insufficient clinical trials – patients who need these drugs for FDA-approved uses are facing shortages.

Today, U.S. Rep. Diana DeGette (D-CO) sent a letter to Food and Drug Administration Commissioner Dr. Stephen M. Hahn urging his agency to take immediate actions to address the dangerous hoarding of these drugs.

“While I support continued research to study hydroxychloroquine, chloroquine and any other drug as a potential treatment to COVID-19, it is imperative that patients with FDA-approved indications for use are able to access their medications,” DeGette wrote. “Their lives depend on it.”

DeGette, chair of the Energy and Commerce Committee’s Oversight and Investigations panel – which oversees the nation's health care industry – called on FDA to issue a warning to health care providers against prescribing hydroxychloroquine and chloroquine for non-FDA-approved uses. This would help alleviate the current drug shortages and ensure patients who rely on these medications can access their treatments.

On March 28, FDA issued an emergency use authorization for both medications, despite the limited in-vitro and “anecdotal” evidence of efficacy for the treatment of the novel coronavirus. The CDC noted that “there are no currently available data from Randomized Clinical Trials (RCTs) to inform clinical guidance on the use, dosing, or duration of hydroxychloroquine for prophylaxis or treatment of [COVID-19].”

Since the emergency use authorization was issued, patients who rely on these drugs to treat conditions like lupus, rheumatoid arthritis and malaria have reported shortages across the country, including in DeGette’s home state of Colorado. On March 31, FDA added both hydroxychloroquine and chloroquine to its drug shortage list.

In addition to issuing a warning to providers against unnecessarily prescribing these medications, DeGette is asking Dr. Hahn to detail the steps FDA is taking to ensure current supplies of hydroxychloroquine and chloroquine are reserved for patients taking them for FDA-approved uses. She also wants to know FDA’s plan to address the current hydroxychloroquine shortage, and whether supplies of these drugs from the nation’s Strategic National Stockpile can be used to treat patients with FDA-approved uses in addition to COVID-19 patients.

A PDF copy of the letter is available here.

Following is the full text:

April 8, 2020

Stephen M. Hahn, M.D.

Commissioner of Food and Drugs

10903 New Hampshire Avenue

Silver Spring, MD 20993

 

Dear Dr. Hahn:

I am writing regarding concerns I have about reports of hoarding and utilizing certain medications to treat COVID-19, without adequate clinical data that point to their efficacy. Additionally, I am concerned that the publicity certain treatments are receiving are putting the populations that rely on them to survive at extreme risk.

Specifically, hydroxychloroquine (HCQ) and chloroquine (CQ) are currently used by tens of thousands of Americans to treat lupus, rheumatoid arthritis (RA), and malaria. As you know, these three conditions are the only indications for which these drugs are approved by the Food and Drug Administration (FDA). In fact, HCQ and CQ are often the only course of treatment for these patients.

On March 28, 2020, FDA issued an emergency use authorization (EUA) for both HCQ and CQ despite the limited in-vitro and “anecdotal” evidence of efficacy for the treatment of the coronavirus disease (COVID-19). The Centers for Disease Control and Prevention note “there are no currently available data from Randomized Clinical Trials (RCTs) to inform clinical guidance on the use, dosing, or duration of hydroxychloroquine for prophylaxis or treatment of [COVID-19].”  

Since the above-referenced EUA was issued, patients with lupus and RA have already been reporting the inability to access their medications. Shortages continue to be reported across the country, including in my home state of Colorado, and on March 31, 2020 FDA added both HCQ and CQ on their drug shortage list. I am particularly concerned about anecdotes of hoarding practices of these drugs to have “just in case” as well as inappropriate prescribing of these experimental treatments which seem to be exacerbating the drug shortage issue.

To mitigate this fast-growing problem, a number of states have already begun imploring providers to restrict dispensing of HCQ and CQ solely for FDA-approved indications of use or as a part of a state-approved clinical trial.  Until further information can be ascertained to prove the efficacy of these drugs for the treatment of COVID-19, I urge FDA to issue a Dear Health Care Provider Letter to warn providers against prescribing HCQ or CQ for non-FDA-approved indications for use. This would help alleviate the current drug shortage, ensure patients who rely on these medications can access their treatments, and address the misuse of these important therapeutics.

Lastly, the following information would be helpful:

  • What immediate and proactive actions is FDA taking to ensure current supplies of HCQ and CQ are allocated for patients taking them for FDA-approved indications?
  • What is FDA doing to address the current HCQ shortage?
  • Are disbursed SNS supplies of HCQ and CQ able to be used to treat patients with FDA-approved indications in addition to COVID-19 patients?
  • If so, is FDA coordinating with the Assistant Secretary for Preparedness and Response (ASPR) to use the SNS supplies to alleviate the drug shortage of HCQ?

While I support continued research to study HCQ, CQ, and any other drug as a potential treatment to COVID-19, it is imperative that patients with FDA-approved indications for use are able to access their medications. Their lives depend on it.

Your swift response is appreciated.

Sincerely,

Diana DeGette

Member of Congress