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Assuring Safety, Access, & Affordability for Taxpayer-Funded Regeneron Antibody Treatment

October 13, 2020

***For Immediate Release***

Press release header

FOR IMMEDIATE RELEASE

October 13, 2020

Contact: Kate Stotesbery

202-494-4620

 

Assuring Safety, Access, & Affordability for Taxpayer-Funded Regeneron Antibody Treatment

Washington, D.C. – U.S. Representative Lloyd Doggett (D-TX), Chair of the Ways and Means Health Subcommittee, pressed the Food and Drug Administration (FDA) and Operation Warp Speed leaders to clearly disclose details of and ensure the transparency, independent review, and affordable pricing for Regeneron’s COVID-19 antibody treatment—a treatment that has received over $500 million dollars in American taxpayer investments and is now under intense focus after President Trump’s treatment and praise. The guardrails against price-gouging on this treatment developed with taxpayer dollars, however, remain very opaque.

“Taxpayers deserve access to a treatment whose development they funded after it satisfies science-led safety standards,” said Chairman Doggett. “With the President’s election-eve rush apparently personally intervening with the FDA, it is essential to guarantee strong guardrails to protect safety, access, and affordability.”

In his letter, he wrote: “This week, President Trump announced that an emergency use authorization (EUA) is ‘all set’ and likened the treatment to a cure, though no evidence has been provided that this represents a cure and little concerning its therapeutic benefit. Reportedly, he has spoken directly with Commissioner Hahn to urge immediate authorization for this treatment. It is imperative that political pressure not lead to premature authorization.”

Chairman Doggett sought answers about the Emergency Use Authorization process; the manufacturing, distribution, and prioritization plans; and the research and development investments and pricing and procurement.

You can read his full letter here or below:

 

Dr. Stephen Hahn

Commissioner

Food and Drug Administration

10903 New Hampshire Ave.

Silver Spring, MD 20993

 

Alex Azar

Secretary

Department of Health and Human Services

200 Independence Ave. SW

Washington, DC 20201

 

Mark T. Esper

Secretary

Department of Defense

1400 Defense Pentagon

Washington, DC 20301

 

Moncef Slaoui

Chief Advisor

Operation Warp Speed

Department of Health and Human Services

200 Independence Ave. SW

Washington, DC 20201

 

Dear Commissioner Hahn, Secretary Azar, Secretary Esper, and Mr. Slaoui,

I write concerning the critical need for transparency, independent review, and affordable pricing for Regeneron’s COVID-19 antibody treatment—a treatment that has received over $500 million dollars in American taxpayer investments.  This week, President Trump announced that an emergency use authorization (EUA) is “all set” and likened the treatment to a cure, though no evidence has been provided that this represents a cure and little concerning its therapeutic benefit.  Reportedly, he has spoken directly with Commissioner Hahn to urge immediate authorization for this treatment.  It is imperative that political pressure not lead to premature authorization.

The President has previously advocated for authorization of treatments, one of which, hydroxychloroquine, has since been revoked due to its dangerous, even deadly, impact on some patients.  EUAs and regulatory approvals must be based on scientific evidence and subject to independent review.  All clinical trial data should be made public prior to authorization and the safety and efficacy of the product must be of the utmost and sole concern.

To ensure an open and evidence-based decision-making process, and transparency on the manufacturing, distribution, patient prioritization, and pricing plans for Regeneron’s antibody treatment, I respectfully request the following information and answers:

Emergency Use Authorization Process

  1. Will you commit to publicly releasing all clinical trial data, safety and efficacy data, and any accompanying analysis at least one week prior to issuing an emergency use authorization or full regulatory approval for Regeneron’s COVID-19 antibody treatment?
  2. Please provide the safety and efficacy standards the FDA will require Regeneron to meet prior to issuing an EUA or full regulatory approval for its antibody treatment.
  3. Please provide any commitments or plans the FDA will require of Regeneron prior to issuing an EUA or full regulatory approval, including commitments to completing clinical trials, plans for monitoring patients who receive the treatment, or any other condition the FDA may place on the authorization or approval.

Manufacturing, Distribution, and Prioritization

  1. Please provide the unredacted manufacturing agreements the federal government, or its subcontractors, has entered into with Regeneron for its COVID-19 antibody treatment.
  2. Please provide the unredacted distribution agreements the federal government, or its subcontractors, has entered into with any private company to distribute the Regeneron COVID-19 antibody treatment. 
  3. Please provide a detailed description of storage and transport requirements for the Regeneron antibody treatment, including necessary supplies, storage temperatures, and expiration dates for doses.  Please also provide a list of supplies already secured and any additional supplies needed to support anticipated doses.
  4. Please provide a detailed analysis on the current status of manufacturing capacity and any additional facilities that may be built, renovated, or retrofitted to manufacture the antibody treatment, as well as any companies that have received a license to manufacture the treatment.
  5. Please provide the formula that will be used to allocate doses.  This information should specify whether doses will be sent to states or directly to health care providers, and the formula to determine how many doses each entity shall receive.  Please include the data and reasoning used to make these determinations.
  6. Please provide any guidance states and/or health providers will receive regarding the prioritization of patients to receive the Regeneron antibody treatment, as well as the data and reasoning used to make this determination.

Research and Development Investments and Pricing and Procurement

  1. Please the unredacted research and development funding agreements the federal government, or its subcontractors, has entered into with Regeneron for its COVID-19 antibody treatment.
  2. Will you commit to establishing a formula for determining a reasonable price for the Regeneron antibody treatment?  If yes, please include a detailed summary of the formula, how the Secretary will enforce this reasonable price, and to what extent it accounts for taxpayer investments made in the research, development, and manufacturing and production of the drug.  If no, please provide an explanation for not negotiating a reasonable price and an explanation for how the Secretary will protect taxpayer investments and equitable access with fair and reasonable pricing.
  3. Will you commit to providing the Regeneron antibody treatment to all patients for free, including the cost of the dose, its administration, and any associated office visits?  Will you ensure that uninsured and underinsured individuals receive the same access and free-of-charge treatment?  Please provide a detailed explanation of how you will ensure insured, uninsured, and underinsured individuals receive free and equal access to this treatment.
  4. Will you commit to providing the Regeneron antibody treatment free of charge to states and health care providers?  If no, please provide an explanation for charging these entities as well as the estimated price per dose.  Please also provide a detailed explanation of how you will ensure all patients, regardless of insurance status, still receive free access to the treatment even when their provider or state has been charged for it.

Taxpayers have spent over half a billion dollars financing the research, development, and manufacturing of Regeneron’s antibody treatment. They have assumed all of the risk in this endeavor, and in return, taxpayers should receive a safe, effective, and affordable product.

Sincerely,

Lloyd Doggett

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