Buddy Carter

09/24/2021 | Press release | Distributed by Public on 09/24/2021 09:52

Carter Concerned Over HHS Policy Change in Monocolonal Antibody Therapies

U.S. Representatives Earl L. "Buddy" Carter, R.Ph., (R-GA) and Scott DesJarlais, M.D., (R-Tenn) authored a letter to the Department of Health and Human Services Secretary Xavier Becerra expressing concerns over the distribution of monoclonal antibody therapies.
The Department of Health and Human Services made changes to the policy just days after President Biden announced multiple executive orders for vaccination mandates.

Representative Carter and DesJarlais write in the letter, "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."

They made it clear to Secretary Becerra that while they are grateful for President Trump's successful execution of Operation Warp Speed to expedite the creation and distribution of the COVID-19 vaccine, that Americans cannot be completely reliant on the vaccination.
"...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," the letter reads. "Accordingly, we strongly urge you to reconsider the order."

The congressmen posed the following questions to Becerra and requested a response:

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?

Carter thanks his colleagues for joining him in the fight to ensure that the distribution process for delivering monoclonal antibodies to states in need is open and transparent.

Full text of the letter can be found here.