January 27, 2022

By Naomi Lopez

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. 

Both antivirals show significant promise — Paxlovid may reduce hospitalization and death by 88 percent, and Molnupiravir by 30 percent. But ultimately, these numbers will only matter to patients who can access these treatments — when they need them.

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.

In order to access the treatment, patients must first obtain a COVID test, which can be difficult in some hard-hit areas, then get the approval of a physician (or other medical provider, usually in a physician’s office or the like), and then make their way to the pharmacy to fill the prescription. But remember: The treatment is most effective within the first five days of symptom onset, which means high-risk patients face a complicated race against the clock.

One of the success stories of the pandemic has been the ability of health care providers, including pharmacists, to practice at the top of their education and training. Pharmacies are not only convenient, but they enjoy an enormous amount of trust from their communities, and they have been indispensable in the fight against COVID-19. The federal government granted pharmacies the authority to provide immunizations, and they have since administered more than 215 million doses, not to mention an untold number of COVID tests.

Yet, the FDA stopped short of giving them similar authority when it comes to these two antivirals.

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.

And since the previously authorized IV treatment of monoclonal antibodies seem to be ineffective against the current, dominant omicron variant, the Biden administration has now halted shipments of this treatment to the states. Even though the two, recently authorized antiviral pills are currently facing supply shortages, the federal government should make every effort to ease access to the best, currently available treatments.

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.

Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.

This article was originally published by The Hill.

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