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[SARS-CoV-2]omnicron [variant] complicates [marketing] at-home Covid pill [in USA]; UK, EU marketing omitted
The FDA will likely specify which "high risk" populations should have access to the Merck-Ridgeback Biotherapeutics pill if they contract Covid-19. That still will leave [licensed medical] doctors and other providers [of WHAT?] on the hook for making ["]judgment calls["] on whether to prescribe the pill -- and to do it within five days of a patient showing symptoms -- in order to realize the potential benefits.
supply chain controversy: US licensed pharmacists do not prescribe Rx; they compound, fulfill, dispense pharmaceutical products.
But supplies of the pill will likely be limited at first. The federal government has purchased 3.1 million courses of molnupiravir, which it will acquire between the date of FDA authorization and early next year. It has the option of purchasing an additional two million doses later, if needed.

A senior federal health official said if authorized, the pills bought by the federal government will be provided free of cost to localities[sic] that can distribute [market] them through health departments, community health centers and pharmacies [marketing channels]. "We continue to work with jurisdictions to plan for distribution and use of these products that will be consistent with clinical guidelines [medical diagnostic criteria] and recommendations for who should receive them," the official said.

"death panelists" or "equity" avengers?
In Merck's trials, however, the pill was only tested on unvaccinated adults, which makes some health experts wonder if the pills will only be available to that group. With an unvaccinated population at just over 99 million people, according to the Centers for Disease Control, three million doses is "a drop in the bucket," said Eunice Neeley [MD, PHP], a preventive medicine specialist and primary care provider based in New Orleans, Louisiana.
Carlos del Rio [MD], an executive associate dean and infectious disease specialist at the Emory School of Medicine, said that the pills "should work" against other variants because of how they stop the virus from replicating. But it will be important to collect more clinical data to be sure, he added.
If pharmacists don't participate [diagnose COVID-19], patients might have to make doctors appointments, delaying when they can begin the regimen.
novel EUA launch? From prescription pad to store shelf
To get FDA approval to change a prescription drug's classification to ["over-the-counter"] OTC [medicine], the product's manufacturer must prove its medication's safety and efficacy.11 Generally drugs can become OTC if:
  • They have low potential for misuse and abuse.
  • They are used for self-diagnosed conditions.
  • They can be used safely and effectively without a health care provider's instruction.
  • They can be adequately labeled.
In late-stage clinical trials, molnupiravir was shown to be about 30 percent effective at preventing hospitalization in at-risk patients, compared to a placebo. For comparison, [monoclonal] antibody treatments [intravenous or subcutaneous injection] that are administered in clinics and hospitals are about 70 percent effective.
The most important thing, they argue, is stopping future infections before they happen. "This will not help us out of the pandemic because it is a treatment and not a prevention," said [Dorry] Segev[MD, PhD]. "The way out of this pandemic is prevention."
too late! NEXT! ...
by Cat on Sat Dec 4th, 2021 at 05:34:41 PM EST
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