The following op-ed has been authored by a non-clinician, it does not constitute medical advice.
In an effort to boost access to the antiviral Paxlovid, the Food and Drug Administration (FDA) will now allow pharmacists to prescribe the medicine; the agency announced this last week, on July 6.
Previously, patients seeking the drug, which has proven highly effective at preventing severe illness and death from COVID-19, needed a prescription from a doctor.
That hurdle never really made sense. Paxlovid must be taken no more than five days after symptoms develop in order to have much effect.
Forcing people to secure a doctor’s appointment before accessing the drug makes timely treatment next-to-impossible in many cases.
Who knows how many people who contracted COVID and might have benefited from Paxlovid died because they were unable to get it in time? Unfortunately, this is standard operating procedure for the FDA — taking its sweet time before allowing patients access to effective treatments.
The data regarding Paxlovid’s effectiveness are astounding.
In a study published last month, just 0.1% of COVID patients who received Paxlovid were hospitalized during the five to 15 days following treatment. Only 0.7% visited an emergency room.
Easy access to Paxlovid might not matter much to young and healthy people with little fear of the virus. But for at-risk patients, such as older people and those with serious chronic conditions, a medicine that can virtually eliminate the chances of landing in the hospital from COVID-19 is life-changing.
Indeed, Dr. Anthony Fauci, the president’s chief medical adviser, said that he believed Paxlovid kept him out of the hospital after he tested positive for COVID last month.
At the same time, an antiviral like Paxlovid should offer hope that we need not return to mandated masking and social distancing.
There’s no justification for the permanent state of emergency that so many in the public health community are calling for if people have easy access to a therapy like Paxlovid — not to mention effective vaccines.
From the moment Paxlovid’s life-saving potential became apparent, health officials should have done everything in their power to get the drug to all who needed it. But that’s not what happened.
The federal government did make the drug free for at-risk individuals last year — and sent millions of Paxlovid pills to pharmacies around the country. But fewer than half of those doses found their way to patients.
The FDA’s previous requirement that only doctors could prescribe the medicine is one reason why. For people who live in medically underserved communities, visiting a doctor on short notice may not be an option.
It’s disproportionately these communities that paid the price for the FDA’s harsh rules.
Consider a recent study by researchers at the Centers for Disease Control and Prevention, (CDC) which found that patients living in ZIP codes deemed “socially vulnerable” received COVID-19 antivirals — including Paxlovid — less often than those living in more advantaged areas.
That’s despite the fact that vulnerable ZIP codes have more places at which patients can receive these medicines.
The slow rollout of Paxlovid offers yet more evidence for relaxing government regulations that constrict the supply of healthcare.
For instance, policymakers could scrap scope-of-practice laws that needlessly prevent nurse practitioners, physician assistants, and other qualified medical professionals from administering treatments and performing procedures without the supervision of a doctor.
Rules banning physicians from practicing outside of a specific state — and thus creating a doctor shortage where there needn’t be one — are another prime candidate for rollback.
The decision to allow pharmacists to prescribe Paxlovid stands out as a rare instance where FDA officials admitted that their own rules and requirements actually endangered public health. They might consider getting out of the way more often.
Improving Access to Paxlovid Long Overdue
Sally C. Pipes
The following op-ed has been authored by a non-clinician, it does not constitute medical advice.
In an effort to boost access to the antiviral Paxlovid, the Food and Drug Administration (FDA) will now allow pharmacists to prescribe the medicine; the agency announced this last week, on July 6.
Previously, patients seeking the drug, which has proven highly effective at preventing severe illness and death from COVID-19, needed a prescription from a doctor.
That hurdle never really made sense. Paxlovid must be taken no more than five days after symptoms develop in order to have much effect.
Forcing people to secure a doctor’s appointment before accessing the drug makes timely treatment next-to-impossible in many cases.
Who knows how many people who contracted COVID and might have benefited from Paxlovid died because they were unable to get it in time? Unfortunately, this is standard operating procedure for the FDA — taking its sweet time before allowing patients access to effective treatments.
The data regarding Paxlovid’s effectiveness are astounding.
In a study published last month, just 0.1% of COVID patients who received Paxlovid were hospitalized during the five to 15 days following treatment. Only 0.7% visited an emergency room.
Easy access to Paxlovid might not matter much to young and healthy people with little fear of the virus. But for at-risk patients, such as older people and those with serious chronic conditions, a medicine that can virtually eliminate the chances of landing in the hospital from COVID-19 is life-changing.
Indeed, Dr. Anthony Fauci, the president’s chief medical adviser, said that he believed Paxlovid kept him out of the hospital after he tested positive for COVID last month.
At the same time, an antiviral like Paxlovid should offer hope that we need not return to mandated masking and social distancing.
There’s no justification for the permanent state of emergency that so many in the public health community are calling for if people have easy access to a therapy like Paxlovid — not to mention effective vaccines.
From the moment Paxlovid’s life-saving potential became apparent, health officials should have done everything in their power to get the drug to all who needed it. But that’s not what happened.
The federal government did make the drug free for at-risk individuals last year — and sent millions of Paxlovid pills to pharmacies around the country. But fewer than half of those doses found their way to patients.
The FDA’s previous requirement that only doctors could prescribe the medicine is one reason why. For people who live in medically underserved communities, visiting a doctor on short notice may not be an option.
It’s disproportionately these communities that paid the price for the FDA’s harsh rules.
Consider a recent study by researchers at the Centers for Disease Control and Prevention, (CDC) which found that patients living in ZIP codes deemed “socially vulnerable” received COVID-19 antivirals — including Paxlovid — less often than those living in more advantaged areas.
That’s despite the fact that vulnerable ZIP codes have more places at which patients can receive these medicines.
The slow rollout of Paxlovid offers yet more evidence for relaxing government regulations that constrict the supply of healthcare.
For instance, policymakers could scrap scope-of-practice laws that needlessly prevent nurse practitioners, physician assistants, and other qualified medical professionals from administering treatments and performing procedures without the supervision of a doctor.
Rules banning physicians from practicing outside of a specific state — and thus creating a doctor shortage where there needn’t be one — are another prime candidate for rollback.
The decision to allow pharmacists to prescribe Paxlovid stands out as a rare instance where FDA officials admitted that their own rules and requirements actually endangered public health. They might consider getting out of the way more often.
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.