Letter to Xavier Becerra, Secretary of Health and Human Services, Janet Woodcock, Commissioner of the Food and Drug Administration - Congresswoman Kat Cammack Sends Letter To HHS, FDA Leaders Over Abrupt End To Use Of Monoclonal Antibody Therapies On COVID-19 Patients

Press Release

Dear Secretary Becerra, Commissioner Woodcock:

I write to express concerns with the Food and Drug Administration's (FDA) January 24, 2022 announcement to abruptly end the use of two monoclonal antibody therapies (mAbs) on patients infected with COVID-19. This announcement has created a severe gap in treatment options for patients who have been infected or are at risk of infection from COVID-19.

Without advance warning, the FDA updated the Emergency Use Authorization (EUA) for Eli Lilly's Bamlanivimab-Etesevimab and Regeneron's REGEN-COV mAbs, stating that these treatments are not authorized for use in any U.S. state, territory, or jurisdiction at this time. Because of the FDA's sudden decision, Florida's state-supported mAb treatment sites now lack access to potentially lifesaving treatments and are closed until further notice.

As you know, mAb therapies have been shown to reduce the amount of the SARS-COV-2 virus that resides within a patient's system and can reduce the severity of symptoms. Furthermore, studies have shown that a treatment course of mAbs can help reduce COVID-19 hospitalization rates by as much as seventy percent.

I have heard from medical professionals across Florida and across the country that monoclonal antibody treatments can save lives and that ensuring providers have access to these treatments is an important component of fighting the spread of COVID-19, even if certain treatments are only partially effective. It is essential to have as many treatment options available as possible, so that providers can make the best decisions on a patient-by-patient basis.

The FDA's decision to restrict use of certain mAbs is based on the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel recommendations. Yet the panel's recommendation lacks any clinical data available and removes a valuable tool for our country's health care providers. Indeed, the panel states in its pre-print studies of the mAbs in question that "despite observing differences in neutralizing activity with certain mAbs, it remains to be determined how this finding translates into effects on clinical protection against B.1.1.529 (Omicron)." It is therefore concerning that the FDA, using insufficient information, and no clinical data, have now removed an important method of treatment of COVID-19.

The FDA has pointed to Paxlovid and Molnupiravira--prescription-only treatments--as better alternatives for COVID-19 patients and has assured us that 71,000 doses are available. In my district in North Florida for example, Paxlovid and Molnupiravir are currently not reported to be available at any local pharmacy. This Administration's choice to prohibit use of certain mAbs has clearly left a severe gap in options for Floridians, particularly high-risk patients seeking potentially life-saving treatment.

A consistent supply of various treatment methods, as well as the introduction of new therapeutics, are key to our country's continued response to the spread of COVID-19. I respectfully ask that the FDA reverse this decision and reauthorize Bamlanivimab-Etesevimab and REGEN-COV as potential treatment options. I also ask that you explain why HHS failed to coordinate with the State of Florida on this change in policy. Finally, I ask that you provide a detailed plan for how the Administration plans to make fully available the Paxlovid, Sotrovimab, Remdesivir, and Molnupiravir and any other authorized treatment options that are currently in scarce supply in many communities.

I appreciate your prompt attention to this matter.

Sincerely,

Kat Cammack
Member of Congress

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