Malliotakis introduces bill to bar racial/ethnic discrimination for COVID-19 treatment access
Rep. Nicole Malliotakis and fellow Republican Congressmen Rodney Davis of Illinois and Andrew Garbarino of New York introduced the Equal Access to Therapeutics Act on Tuesday to prevent the federal government from distributing COVID-19 therapeutic treatments based on race or ethnicity.
According to Malliotakis’ office, the legislation is in response to guidance issued by New York City and state as well as other states for determining patient eligibility for COVID-19 monoclonal antibody treatments and therapeutics.
The Equal Access to Therapeutics Act sponsors assert that the guidance suggesting race be taken race into account as a factor that can increase a patients’ risk for severe illness would allow for unequal distribution of COVID-19 treatments.
“New York City and state’s decision to allocate therapeutic treatments by race rather than an individual’s medical condition is wrong,” Malliotakis said.
“Allocation and the administrations of these life-saving treatments should be based solely on an individual’s health need,” the congresswoman added.
DEPT. OF HEALTH & FDA GUIDANCE
In the guidance that the New York State Dept. of Health released at the end of Dec. 2021, the department lists the following criteria for a COVID-19 patient to be eligible for oral antiviral treatments:
- Age 12 years and older weighing at least 40 kg (88 pounds) for Paxlovid, or 18 years and older for molnupiravir.
- Test positive for SARS-CoV-2 on a nucleic acid amplification test or antigen test; results from an FDA-authorized home-test kit should be validated through video or photo but, if not possible, patient attestation is adequate.
- Have mild to moderate COVID-19 symptoms
- Patient cannot be hospitalized due to severe or critical COVID-19
- Able to start treatment within five days of symptom onset.
- Have a medical condition or other factors that increase their risk for severe illness.
- Non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19.
Similarly, the U.S. Food and Drug Administration (FDA)’s Emergency Use Authorization (EUA) of Sotrovimab authorizes use of the monoclonal antibody therapy for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The guidance lists “medical conditions or other factors” that may place patients at “higher risk for progression to severe COVID-19″ such as older age, obesity, pregnancy, chronic kidney disease, diabetes, immunosuppressive disease or treatment, lung diseases, sickle cell disease and neurodevelopmental disorders.
The FDA notes that this isn’t an exhaustive list of factors and “other medical conditions or factors (for example, race or ethnicity)” could also increase the risk of patients developing severe COVID-19.
Neither guidance requires distribution of the treatment to be based on a patient’s race or ethnicity, but instead suggests the consideration of race or ethnicity as it pertains to risk of severe progression of COVID-19 in patients.
EQUAL ACCESS TO THERAPEUTICS ACT SPECIFIC PROVISIONS
The Equal Access to Therapeutics Act would specifically:
- Restrict the Secretary of Health and Human Services (HHS) from issuing, implementing, or continuing to have in effect any guidance intended to restrict access to COVID-19 monoclonal antibody therapies and other treatments based on the race or ethnicity of a patient.
- Hold the Secretary of HHS personally liable for the death of any individual who is denied access to the treatments based on race or ethnicity.
- Prohibit federal funding to hospitals and healthcare providers who restrict access to these treatments based on race or ethnicity.