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GOP Doctors Caucus Members Lead Letter to HHS Regarding Federal Takeover of Distribution of Key COVID-19 Treatment

Washington, September 24, 2021 Contact:

WASHINGTON, D.C. — GOP Doctors Caucus members Reps. Scott DesJarlais, M.D., (R-Tenn.) and Buddy Carter, R.Ph., (R-Ga.) led members of House Republican Conference, including Leader Kevin McCarthy (R-Calif.) and Conference Chair Elise Stefanik (R-N.Y.), in writing to Secretary of Health and Human Services Secretary Xavier Becerra, expressing concerns about a recent decision to transition monoclonal antibody distribution from a direct ordering process to a federally controlled distribution process.

“This change in distribution threatens to reduce or delay access to this life saving therapy for the patients who need it most. Additionally, a slight delay in administration of this therapy could be fatal. As you know, providers and health systems are already required to report mAb distribution data to HHS. The federal government should not hinder the efforts of providers seeking to procure and administer this product. Disallowing direct supply of mAb while a new distribution system is being developed will cause further delays,” the members wrote.

You can view the full letter here.

 

September 23, 2021

The Honorable Xavier Becerra

Secretary

U.S. Department of Health and Human Services

200 Independence Avenue SW

Washington, DC 20201

 

Dear Secretary Becerra,

 

We write to express concerns with the U.S. Department of Health and Human Services (HHS)

September 13th, 2021 announcement to abruptly transition monoclonal antibody (mAb)

distribution from a direct ordering process to a federally controlled distribution process.

 

Overnight, our healthcare providers were made aware that they may run out of mAbs, at a time

of heightened demand, as states will need to sift through layers of bureaucracy and contracting in

order to safely and accurately distribute the lifesaving treatment. Many states do not have the

infrastructure in place to take on this unnecessary challenge amidst a spike in COVID-19 cases

and will likely need to spend scarce state resources to contract solutions. This type of change is

ill advised and will lead to significant delays that will limit patient access to mAb treatment in

many states.

 

As you are aware, the Food and Drug Administration (FDA) has granted Emergency Use

Authorization (EUA) to several mAb therapies as treatment for COVID-19. This therapy is

known to reduce the amount of the SARS-CoV-2 virus that may reside within a patient’s system

and is most effective if a patient has had symptoms for ten days or less. Time is of the essence

for administering this therapy most effectively. A study from the New England Journal of

Medicine shows that a treatment course of mAbs can reduce COVID-19 hospitalization rates up

to seventy percent.

 

We have heard from physicians, providers, and hospitals in our respective states that the use of

mAbs has saved countless lives. Prior to this announcement, the private distribution network

worked well – getting providers and their patients the therapies they needed in a timely fashion.

Now, we have heard from providers in our state who cannot get orders for mAbs as states

scramble to set up a new distribution methodology.

 

This change in distribution threatens to reduce or delay access to this life saving therapy for the

patients who need it most. Additionally, a slight delay in administration of this therapy could be

fatal. As you know, providers and health systems are already required to report mAb distribution

data to HHS. The federal government should not hinder the efforts of providers seeking to procure and administer this product. Disallowing direct supply of mAb while a new distribution

system is being developed will cause further delays.

 

In regards to our concern, we have a number of questions for the agency:

 

1. What allocation formula and criteria are being used to ensure fairness among the states

for the distribution of mAb?

2. How do you plan to manage the mAb inventory?

3. How are you communicating to stakeholders who need mAb supply right now?

4. Do you plan to federally allocate future COVID-19 therapeutics in this way?

5. How many treatments were administered in underserved communities as a result of $150

million allocated to expand mAbs access to underserved communities2?

6. While HHS is anticipating a mAb shortage, why are there mAbs available under EUA

that the government has stated it will not purchase?

 

We are very concerned with this sudden change, which further emphasizes the urgent need for

investment from this Administration in COVID-19 therapeutics. As we have seen from

breakthrough cases, we know that vaccinated people can contract COVID-19. New variants of

the COVID-19 virus are expected to occur, as is seen across different viruses. In order for the

United States to remain resilient against COVID-19 in the face of novel variants and uncertainty

regarding length of immunity from vaccination, we must deploy every available means to

combat the disease and prevent hospitalizations and deaths. The development of new COVID-19

therapeutics, as well as a predictable supply of currently available treatments such as mAb, are

key as the country continues to respond to the public health emergency.

 

Thanks to Operation Warp Speed, safe and effective vaccines against COVID-19 are readily

available and we continue to encourage Americans to consult with their physician and get

vaccinated. However, therapeutics remain a crucial weapon in our fight against this virus, and

this order threatens our constituents’ access to some of the most effective available options. Accordingly, we strongly urge you to reconsider the order.

 

We appreciate your prompt attention to this matter.

 

Sincerely,

 

Scott DesJarlais, M.D.

Member of Congress

 

Earl L. "Buddy" Carter, R. Ph.

Member of Congress

 

Kevin McCarthy

Republican Leader

 

Elise M. Stefanik

Member of Congress

 

Andy Harris, M.D.

Member of Congress

 

Brad R. Wenstrup, D.P.M.

Member of Congress

 

Michael C. Burgess, M.D.

Member of Congress

 

Brian Babin, D.D.S.

Member of Congress

 

Larry Bucshon, M.D.

Member of Congress

 

Neal P. Dunn, M.D.

Member of Congress

 

A. Drew Ferguson IV

Member of Congress

 

Mark E. Green, M.D.

Member of Congress

 

Diana Harshbarger

Member of Congress

 

Ronny L. Jackson, M.D.

Member of Congress

 

John Joyce, M.D.

Member of Congress

 

Mariannette Miller-Meeks, M.D.

Member of Congress

 

Gregory F. Murphy, M.D.

Member of Congress

 

Jefferson Van Drew

Member of Congress

 

Jim Banks

Member of Congress

 

Pete Sessions

Member of Congress

 

Mike Rogers

Member of Congress

 

Robert B. Aderholt

Member of Congress

 

Daniel Webster

Member of Congress

 

Michael Waltz

Member of Congress

 

Lance Gooden

Member of Congress

 

William R. Timmons IV

Member of Congress

 

Brian J. Mast

Member of Congress

 

Kevin Brady

Member of Congress

 

Randy K. Weber, Sr.

Member of Congress

 

Austin Scott

Member of Congress

 

Jodey C. Arrington

Member of Congress

 

August Pfluger

Member of Congress

 

Adrian Smith

Member of Congress

 

Andy Barr

Member of Congress

 

Louie Gohmert

Member of Congress

 

Van Taylor

Member of Congress

 

Dan Newhouse

Member of Congress

 

Kat Cammack

Member of Congress

 

Roger Williams

Member of Congress

 

Ted Budd

Member of Congress

 

John H. Rutherford

Member of Congress

 

Kevin Hern

Member of Congress

 

Bob Gibbs

Member of Congress

 

Debbie Lesko

Member of Congress

 

Bob Good

Member of Congress

 

Eric A. "Rick" Crawford

Member of Congress

 

Dan Crenshaw

Member of Congress

 

Jeff Duncan

Member of Congress

 

Marjorie Taylor Greene

Member of Congress

 

Charles J. "Chuck" Fleischmann

Member of Congress

 

Beth Van Duyne

Member of Congress

 

Ben Cline

Member of Congress

 

Warren Davidson

Member of Congress

 

Ralph Norman

Member of Congress

 

Jody B. Hice

Member of Congress