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Battling COVID with One Hand Tied Behind our Back

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Public Advisor
Naomi Lopez is the Director of Health Care Policy for the Goldwater Institute, where she leads the Institute’s efforts to implement federal and state health care reforms that benefit all Americans. She has 25 years of experience in policy and her work focuses on a broad range of health care issues, including the Right to Try, off-label communications, pharmaceutical drug pricing, supply-side healthcare reforms, the Affordable Care Act, Medicaid, and 21st-century health care innovation.

Two years after the first confirmed case of COVID-19 in the U.S., hope is on the horizon in the form of recently authorized antivirals that may protect high-risk COVID patients from severe illness.

Leave it to the federal government to get in the way.

Health officials could make the antivirals more easily accessible to Americans by granting pharmacists the authority to prescribe and dispense them. Unfortunately, federal authorities’ failure to remove bureaucratic obstacles and cut red tape is making it much harder for patients to obtain these potentially life-saving treatments. 

The Food and Drug Administration (FDA) opened the door for these new, promising treatments by issuing a pair of emergency-use authorizations (EUA) last month for Pfizer’s Paxlovid as well as Merck and Ridgeback’s Molnupiravir. Both were authorized for high-risk COVID patients — Paxlovid for people over the age of 12 and Molnupiravir for patients over the age of 18 who are not pregnant. Both treatments are oral, and both are most effective when taken within five days of the onset of symptoms…

Under the EUA, the FDA may evaluate the totality of the scientific evidence, as well as the treatments’ known risks and potential benefits. If the agency determines either treatment may be effective, it can be approved under EUA while the public health emergency remains in effect…

The FDA has the power to authorize pharmacists to prescribe and dispense these antivirals — but it didn’t. While the agency provided no public reason, some suspect the decision was made over concern of potential drug interactions. But pharmacists are often the very providers who have the best insight into a patient’s drug history. They also have previous authorization to prescribe and dispense oral therapeutics under the Public Readiness and Emergency Preparedness (PREP) Act, but the FDA chose to rescind that authority without explanation…

Failing to grant pharmacists the same extension of prescribing authority for these antiviral pills that were granted for the COVID vaccines is another giant misstep. And it’s a reminder that the same federal government that seeks to impose restrictions and rules also bears some responsibility for delaying this important treatment to some of the patients who need it most. It turns what could have been a one-stop shop into a complicated, time-wasting and meaningless chase for the patients most vulnerable to COVID-19.

The full article is available at The Hill.

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