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Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

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Photo: Steve Russell/Toronto Star via Getty Images

There is a new battle brewing among doctors, patient advocates and pharma companies over — believe it or not — human excrement.

Driving the news: The fight is over fecal microbiota transplants, a remarkably effective treatment for the bacterial infection Clostridioides difficile, the New York Times reports. The battle is over whether the treatment — which involves transplanting healthy fecal matter into the bowels of patients suffering from the infection — should be classified as a drug or as a procedure akin to organ, tissue and blood transplants.

The FDA is expected to make a final decision soon, although in 2013 it made a draft decision to regulate the procedure as a drug.

  • The market for drug-based treatments for C. diff is expected to hit $1.7 billion by 2026, according to GlobalData.
  • Following the success of the procedure, scientists are currently trying to come up with similar treatments for disorders like obesity, autism, ulcerative colitis, and Alzheimer’s and Parkinson’s diseases.
  • Investors are pouring money into such endeavors.

One major concern for critics: Treating the therapy as a drug will give it a 12-year monopoly period upon approval.

  • They say this could slow innovation and cause patients who can't afford the procedure to attempt to replicate it at home.
  • And, of course, there's fear that this would lead to high prices for stool transplants.
  • Drug companies say that regulating the procedure as a drug will help ensure its safety and efficacy.

Go deeper

CDC: Fully vaccinated people can gather indoors without masks

Photo: Filip Filipovic/Getty Images

People who have been fully vaccinated against COVID-19 can take fewer precautions in certain situations, including socializing indoors without masks when in the company of low-risk or other vaccinated individuals, according to guidance from the Centers for Disease Control and Prevention released Monday.

Why it matters: The report cites early evidence that suggests vaccinated people are less likely to have asymptomatic infection, and are potentially less likely to transmit the virus to other people. At the time of its publication, the CDC said the guidance would apply to about 10% of Americans.

Dan Primack, author of Pro Rata
37 mins ago - Economy & Business

Ripple CEO calls for clearer crypto regulations following SEC lawsuit

Illustration: Sarah Grillo/Axios

Ripple CEO Brad Garlinghouse tells "Axios on HBO" that if his company loses a lawsuit brought by the SEC, it would put the U.S. cryptocurrency industry at a competitive disadvantage.

Why it matters: Garlinghouse's comments may seem self-serving, but his call for clearer crypto rules is consistent with longstanding entreaties from other industry players.

Republican Sen. Roy Blunt will not seek re-election in 2022

Photo: Alex Wong/Getty Images

Sen. Roy Blunt (R-Mo.), widely seen as a member of the Republican establishment in Congress, will not run for re-election in 2022, he announced on Twitter Monday.

Why it matters: The 71-year-old senator is the No. 4-ranking Republican in the Senate, and the fifth GOP senator to announce he will not run for re-election in 2022 as the party faces questions about its post-Trump future.

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