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Velazquez Presses HHS to Explain Remdesivir Distribution

Velázquez Presses HHS to Explain Remdesivir Distribution
May 14, 2020
Press Release

Washington, DC – Rep. Nydia M. Velázquez (D-NY) is pressing the U.S. Department of Health and Human Services for an explanation on how the agency has distributed donated doses of “remdesivir”, a drug that has shown promise in shortening recovery time for patients suffering from COVID-19.  In a letter to the Secretary of HHS and the agency’s Assistant Secretary for Preparedness and Response, Velázquez asks for a better explanation as to how the agency is prioritizing the medicine’s distribution.

 

Her letter follows conversations with personnel at Wyckoff Heights Medical Center who expressed that the hospital, which has been a coronavirus hotspot, was denied the drug. 

 

“From the outset, the Trump Administration’s response to the pandemic has been characterized by incompetence and cronyism,” said Velázquez. “Now, we’re hearing some hospitals in coronavirus hotspots, often minority communities, were denied access to this vital drug. We need a fuller accounting from HHS on how this drug is being distributed and to be sure HHS is sending doses directly to hospitals that need it most.”

 

“If Trump’s HHS can’t target allocation of this relatively small amount of a donated drug to where it’s needed, it begs the question whether it could effectively handle widespread distribution of a vaccine or other therapies once developed,” she added.  

 

The text of the letter is below and a .pdf is online here

 

The Honorable Alex Azar

Secretary

Department of Health and Human Services

200 Independence Ave SW

Washington, DC 20201

 

The Honorable Robert Kadlec

Assistant Secretary for Preparedness and Response

Department of Health and Human Services

200 Independence Ave SW

Washington, DC 20201

 

Dear Secretary Azar and Assistant Secretary Kadlec:

 

I write today to inquire about the methodologies employed to distribute remdesivir. The U.S. Department of Health and Human Services (HHS) is expected to uphold its duty in protecting the health of all Americans. This includes distribution of remdesivir to all communities, especially those that became COVID-19 hotspots. Now more than ever, it is critical that we support healthcare providers in fighting COVID-19 by providing the appropriate tools and medication to fight this illness.

 

As you know, on May 1st the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of remdesivir to treat hospitalized COVID-19 patients.[1] This occurred two days after the National Institutes of Health’s (NIH) clinical trial showed that patients who received the treatment had a 31% faster recovery time compared with those who received a placebo, a significant step forward in battling COVID-19.[2] Under the Federal Food, Drug and Cosmetic Act, distribution of any drug receiving an EUA is to be controlled by the United States Government for use.  It is my understanding that HHS is responsible for consulting with state and local government authorities in this distribution.

 

However, media reports suggest that doctors across the country are announcing they were “denied access” to remdesivir for their patients.[3] Furthermore, many doctors don’t understand the process for obtaining the drug due to a lack of guidance and transparency from HHS.

 

On Friday, my office was informed that Wyckoff Heights Medical Center, a hospital in my district that serves a large minority population, was denied access to remdesivir. According to Wyckoff Heights Medical Center Staff, they have experienced over 1,000 COVID-19 positive patients, 226 resulting in deaths. Additionally, reports on the ground suggest that Wyckoff Heights’ experience is prevalent at hospitals across the nation, many that also serve a large population of minority patients.

 

To better understand HHS’s decision-making process in distributing doses of remdesivir donated to the U.S. federal government by Gilead Sciences, I request answers to the following questions by Friday, May 15, 2020:

  1. Of the 1.5 million remdesivir vials donated globally by Gilead Sciences[4] it is our understanding that Gilead has committed to supplying approximately 607,000 vials of the experimental drug over the next six weeks. On Saturday, HHS announced cases were distributed to 10 states with each case containing 40 vials.[5] What guidance was given to HHS staff in determining the allocation and prioritization of the donated cases?
  2. Considering HHS expects that cases will be delivered to all 50 states and territories, does HHS plan to consult with local governments for future remdesivir distributions?
    1. Have these methodologies changed since the initial distribution?
    2. Does HHS plan to consult directly with hospitals and health care providers in future remdesivir distributions?
      1. Under what circumstances will HHS consult with hospitals and health care providers?
  3. Current data suggest a disproportionate burden of illness and death among racial and ethnic minority groups. Given this information, did your methodology consider or prioritize regional locations where hospitals are serving low-income communities or communities of color?

Thank you for your attention to this urgent issue and I look forward to your response.

 

Sincerely,

 

 

 

 

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[1] U.S. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment. 01, May 2020. Accessed on 08, May 2020 Retrieved from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment

[2] U.S. National Institute of Health. NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19. 29, April 2020. Accessed on 11, May 2020. Retrieved from: https://www.nih.gov/news-events/news-releases/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19

[3] Washington Post. Trump administration pushed use of remdesivir, but unequal rollout angers doctors. 07, May 2020. Accessed on 09, May 2020. Retrieved from: https://www.washingtonpost.com/business/2020/05/07/remdesivir-hospitals-doctors/

[4] Gilead. Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19. 01, May 2020. Accessed on 11, May 2020. Retrieved from: https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19

[5]U.S. Department of Health and Human Services. HHS announces shipments of donated remdesivir for hospitalized patients with COVID-19. 9, May 2020. Accessed on 11, May 2020. Retrieved from: https://www.hhs.gov/about/news/2020/05/09/hhs-ships-first-doses-of-donated-remdesivir-for-hospitalized-patients-with-covid-19.html

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